Guidance for Industry: Enforcement Policy Concerning Rotational Warning Plans for Smokeless Tobacco; Availability, 32481-32482 [2010-13819]

Download as PDF Federal Register / Vol. 75, No. 109 / Tuesday, June 8, 2010 / Notices 1. Funding Instrument Type 3. Submission Dates and Times To receive consideration, applications must be submitted by 11:59 Eastern time by the deadline listed in the ‘‘Dates’’ section at the beginning of this Notice. These awards will be made in the form of grants to Title VI Native American Programs. V. Responsiveness Criteria Does not apply. 2. Anticipated Total Priority Area Funding per Budget Period VI. Application Review Information Does not apply. AoA intends to make available, under this program announcement, grant awards for $1,000 to 246 projects at a federal share of approximately $246,000 total for a project period of 1 year. VII. Agency Contacts Direct inquiries regarding programmatic issues to U.S. Department of Health and Human Services, Administration on Aging, Office for American Indian, Alaskan Native, and Native Hawaiian Programs, Washington, DC 20201, attention: Yvonne Jackson or by calling 202–357–3501, or by e-mail at Yvonne.jackson@aoa.hhs.gov. www.aoa.gov/doingbus/fundopp/ fundopp.aspx II. Award Information III. Eligibility Criteria and Other Requirements 1. Eligible Applicants Only current Older Americans Act Title VI Native American Program grantees are eligible to apply for this funding. Dated: May 18, 2010. Kathy Greenlee, Assistant Secretary for Aging. 2. Cost Sharing or Matching [FR Doc. 2010–13651 Filed 6–7–10; 8:45 am] BILLING CODE 4154–01–P Cost Sharing does not apply. 3. DUNS Number All grant applicants must obtain a D– U–N–S number from Dun and Bradstreet. It is a nine-digit identification number, which provides unique identifiers of single business entities. The D–U–N–S number is free and easy to obtain from https:// www.dnb.com/US/duns_update/. 4. Intergovernmental Review Executive Order 12372, Intergovernmental Review of Federal Programs, is not applicable to these grant applications. 2. Address for Application Submission emcdonald on DSK2BSOYB1PROD with NOTICES Guidance for Industry: Enforcement Policy Concerning Rotational Warning Plans for Smokeless Tobacco; Availability ACTION: Application kits are available by writing to the U.S. Department of Health and Human Services, Administration on Aging, Office for American Indian, Alaskan Native, and Native Hawaiian Programs, Washington, DC 20201, attention: Yvonne Jackson or by calling 202–357–3501, or online at https:// www.grants.gov. Applications may be submitted by e-mail to grants.office@aoa.hhs.gov, by fax to 202–357–3467 or in hard copy by overnight delivery to the U.S. Department of Health and Human Services, Administration on Aging, Office of Grants Management, Washington, DC 20201, Attn. Sean Lewis. Jkt 220001 [Docket No. FDA–2010–D–0276] AGENCY: 1. Address to Request Application 16:31 Jun 07, 2010 Food and Drug Administration Food and Drug Administration, HHS. IV. Application and Submission Information VerDate Mar<15>2010 DEPARTMENT OF HEALTH AND HUMAN SERVICES Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Enforcement Policy Concerning Rotational Warning Plans for Smokeless Tobacco Products.’’ The guidance is intended to provide information relating to FDA’s enforcement policy concerning section 3 of the Comprehensive Smokeless Tobacco Health Education Act (Smokeless Tobacco Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). This guidance will be implemented immediately, but remains subject to comment in accordance with the agency’s good guidance practices (GGPs). DATES: Submit either electronic or written comments on this guidance at any time. General comments on agency guidance documents are welcome at any time. PO 00000 Frm 00127 Fmt 4703 Sfmt 4703 32481 ADDRESSES: Submit written requests for single copies of the draft guidance document entitled ‘‘Enforcement Policy Concerning Rotational Warning Plans for Smokeless Tobacco Products’’ to the Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850–3229. 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 guidance. Submit electronic comments on the 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: Gail Schmerfeld, Center for Tobacco Products, 9200 Corporate Blvd., Rockville, MD 20850–3229, 240–276– 1717, e-mail: Gail.Schmerfeld@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background On June 22, 2009, the President signed the Tobacco Control Act (Public Law 111–31) into law. The Tobacco Control Act grants 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 204 of the Tobacco Control Act amended section 3 of the Smokeless Tobacco Act (15 U.S.C. 4402) to prescribe new requirements for health warning labels that must appear on smokeless tobacco product packages and advertising, and to require that rotational warning plans for packaging and advertising for smokeless tobacco products be submitted to FDA, rather than to the Federal Trade Commission (FTC). The new warning labels required by section 3 of the Smokeless Tobacco Act must begin to rotate in advertising for smokeless tobacco products beginning on June 22, 2010, and must be distributed and displayed on the packaging of smokeless tobacco products manufactured on or after June 22, 2010, as set forth in section 3(b)(3) of the Smokeless Tobacco Act (section 204(b) of the Tobacco Control Act and section 3(b)(3) of the Smokeless Tobacco Act). In addition, on or after July 22, 2010, manufacturers may not introduce any smokeless tobacco product into E:\FR\FM\08JNN1.SGM 08JNN1 32482 Federal Register / Vol. 75, No. 109 / Tuesday, June 8, 2010 / Notices domestic commerce unless its packaging complies with section 3 of the Smokeless Tobacco Act (Id.). Among the requirements in section 3(b)(3) is that the rotation of label statements on packaging and advertising for each brand of smokeless tobacco must be ‘‘in accordance with a plan submitted by the tobacco product manufacturer, importer, distributor, or retailer’’ to, and approved by, FDA (Id.). At this time, as an exercise of enforcement discretion, FDA does not intend to commence or recommend enforcement of the requirement that a smokeless tobacco manufacturer, distributor, importer, or retailer must have an FDA-approved rotational warning plan, so long as a rotational warning plan has been submitted to FDA by July 22, 2010. FDA believes that allowing additional time for the review of rotational warning plans will permit an orderly transition of regulatory authority from FTC to FDA to review and approve rotational warning plans. During such transition between June 22, 2010, and July 22, 2010, affected companies may wish to contact FDA to discuss the submission of their rotational warning plans in order to make the subsequent approval process more orderly and efficient. FDA intends to provide further public notice prior to revising or rescinding this enforcement policy after the transition from FTC to FDA has been accomplished for the submission and review of rotational warning plans. This enforcement policy pertains only to the requirement that smokeless tobacco manufacturers, distributors, importers, or retailers must have an FDA-approved rotational warning plan. FDA expects compliance with regard to all other requirements of section 3 of the Smokeless Tobacco Act, including the requirements relating to size, formatting, location, and use of required warning statements. emcdonald on DSK2BSOYB1PROD with NOTICES II. Significance of Guidance FDA is issuing this guidance document as a level 1 guidance consistent with FDA’s good guidance practices regulations (21 CFR 10.115). This guidance is being implemented immediately without prior public comment under 10.115(g)(2) because the agency has determined that prior public participation is not feasible or appropriate. This document provides guidance on statutory provisions that take effect June 22, 2010. It is important that FDA explain its enforcement policy concerning the submission and approval of rotational warning plans for smokeless tobacco products before that date. VerDate Mar<15>2010 16:31 Jun 07, 2010 Jkt 220001 III. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. IV. Electronic Access An electronic version of this guidance document is available on the Internet at https://www.regulations.gov and https:// www.fda.gov/TobaccoProducts/ GuidanceComplianceRegulatory Information/default.htm. Dated: June 4, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–13819 Filed 6–4–10; 4:15 pm] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0247] Investigational New Drug Applications; Co-development of Investigational Drugs AGENCY: Food and Drug Administration, HHS. ACTION: Notice; establishment of docket; request for comments. SUMMARY: The Food and Drug Administration (FDA) is establishing a public docket to obtain input on methods to co-develop two or more distinct investigational drugs intended to be used in combination to treat a disease or condition. FDA is planning to develop guidance for industry and other affected parties on the co-development of two or more novel drugs intended to be used in combination (but not as not fixed-dose combinations) and is seeking public input to identify the affected parties’ information needs concerning such co-development. Accordingly, FDA is seeking comment on general methodologic and regulatory issues that arise in various scenarios when codeveloping two or more investigational drugs intended to be used in combination. FDA is also seeking comment on methodologic and regulatory issues when co-developing two or more investigational drugs PO 00000 Frm 00128 Fmt 4703 Sfmt 4703 intended to be used in combination for specific therapeutic areas, including oncology, anti-infectives, seizure disorders, cardiovascular diseases, and any other therapeutic category in which such co-development is likely to occur. DATES: Submit either electronic or written comments by September 7, 2010. ADDRESSES: Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to https:// www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Colleen L. Locicero, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 4200, Silver Spring, MD 20993–0002, 301– 796–2270. SUPPLEMENTARY INFORMATION: I. Background FDA is aware of growing interest in co-developing two or more distinct, novel investigational drugs intended to be used in combination to treat a disease or condition (but not as fixed-dose combinations under 21 CFR 300.50). At a September 2009 conference co-hosted by the ‘‘Friends of Cancer Research’’ in partnership with the Engelberg Center for Health Care Reform at the Brookings Institution, and supported by the American Society for Clinical Oncology (ASCO), the American Association for Cancer Research (AACR) Susan G. Komen for the Cure, and the Lance Armstrong Foundation (Brookings Conference), which was attended by FDA scientists, there was considerable interest in approaches to developing new oncology therapies intended to be used in combination. In addition, on April 30, 2010, FDA held a public hearing in accordance with part 15 (21 CFR part 15) devoted, in part, to obtaining information about study designs and appropriate populations for developing two or more novel, directacting antivirals intended to be used in combination for the treatment of chronic hepatitis C. FDA is also aware of efforts to try to develop two or more investigational drugs intended to be used in combination to treat tuberculosis. FDA is further aware of general uncertainty about the evidentiary requirements and regulatory criteria applicable to such codevelopment efforts. Accordingly, FDA is planning to develop generally applicable guidance (not restricted to oncology or any other specific therapeutic category) to address E:\FR\FM\08JNN1.SGM 08JNN1

Agencies

[Federal Register Volume 75, Number 109 (Tuesday, June 8, 2010)]
[Notices]
[Pages 32481-32482]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-13819]



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



DEPARTMENT OF HEALTH AND HUMAN SERVICES



Food and Drug Administration



[Docket No. FDA-2010-D-0276]




Guidance for Industry: Enforcement Policy Concerning Rotational 

Warning Plans for Smokeless Tobacco; Availability



AGENCY: Food and Drug Administration, HHS.



ACTION: Notice.



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



SUMMARY: The Food and Drug Administration (FDA) is announcing the 

availability of a guidance for industry entitled ``Enforcement Policy 

Concerning Rotational Warning Plans for Smokeless Tobacco Products.'' 

The guidance is intended to provide information relating to FDA's 

enforcement policy concerning section 3 of the Comprehensive Smokeless 

Tobacco Health Education Act (Smokeless Tobacco Act), as amended by the 

Family Smoking Prevention and Tobacco Control Act (Tobacco Control 

Act). This guidance will be implemented immediately, but remains 

subject to comment in accordance with the agency's good guidance 

practices (GGPs).



DATES:  Submit either electronic or written comments on this guidance 

at any time. General comments on agency guidance documents are welcome 

at any time.



ADDRESSES: Submit written requests for single copies of the draft 

guidance document entitled ``Enforcement Policy Concerning Rotational 

Warning Plans for Smokeless Tobacco Products'' to the Center for 

Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., 

Rockville, MD 20850-3229. 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 guidance.

    Submit electronic comments on the 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: Gail Schmerfeld, Center for Tobacco 

Products, 9200 Corporate Blvd., Rockville, MD 20850-3229, 240-276-1717, 

e-mail: Gail.Schmerfeld@fda.hhs.gov.



SUPPLEMENTARY INFORMATION:



I. Background



    On June 22, 2009, the President signed the Tobacco Control Act 

(Public Law 111-31) into law. The Tobacco Control Act grants 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 204 of the Tobacco Control Act amended 

section 3 of the Smokeless Tobacco Act (15 U.S.C. 4402) to prescribe 

new requirements for health warning labels that must appear on 

smokeless tobacco product packages and advertising, and to require that 

rotational warning plans for packaging and advertising for smokeless 

tobacco products be submitted to FDA, rather than to the Federal Trade 

Commission (FTC).

    The new warning labels required by section 3 of the Smokeless 

Tobacco Act must begin to rotate in advertising for smokeless tobacco 

products beginning on June 22, 2010, and must be distributed and 

displayed on the packaging of smokeless tobacco products manufactured 

on or after June 22, 2010, as set forth in section 3(b)(3) of the 

Smokeless Tobacco Act (section 204(b) of the Tobacco Control Act and 

section 3(b)(3) of the Smokeless Tobacco Act). In addition, on or after 

July 22, 2010, manufacturers may not introduce any smokeless tobacco 

product into



[[Page 32482]]



domestic commerce unless its packaging complies with section 3 of the 

Smokeless Tobacco Act (Id.). Among the requirements in section 3(b)(3) 

is that the rotation of label statements on packaging and advertising 

for each brand of smokeless tobacco must be ``in accordance with a plan 

submitted by the tobacco product manufacturer, importer, distributor, 

or retailer'' to, and approved by, FDA (Id.).

    At this time, as an exercise of enforcement discretion, FDA does 

not intend to commence or recommend enforcement of the requirement that 

a smokeless tobacco manufacturer, distributor, importer, or retailer 

must have an FDA-approved rotational warning plan, so long as a 

rotational warning plan has been submitted to FDA by July 22, 2010. FDA 

believes that allowing additional time for the review of rotational 

warning plans will permit an orderly transition of regulatory authority 

from FTC to FDA to review and approve rotational warning plans. During 

such transition between June 22, 2010, and July 22, 2010, affected 

companies may wish to contact FDA to discuss the submission of their 

rotational warning plans in order to make the subsequent approval 

process more orderly and efficient. FDA intends to provide further 

public notice prior to revising or rescinding this enforcement policy 

after the transition from FTC to FDA has been accomplished for the 

submission and review of rotational warning plans. This enforcement 

policy pertains only to the requirement that smokeless tobacco 

manufacturers, distributors, importers, or retailers must have an FDA-

approved rotational warning plan. FDA expects compliance with regard to 

all other requirements of section 3 of the Smokeless Tobacco Act, 

including the requirements relating to size, formatting, location, and 

use of required warning statements.



II. Significance of Guidance



    FDA is issuing this guidance document as a level 1 guidance 

consistent with FDA's good guidance practices regulations (21 CFR 

10.115). This guidance is being implemented immediately without prior 

public comment under 10.115(g)(2) because the agency has determined 

that prior public participation is not feasible or appropriate. This 

document provides guidance on statutory provisions that take effect 

June 22, 2010. It is important that FDA explain its enforcement policy 

concerning the submission and approval of rotational warning plans for 

smokeless tobacco products before that date.



III. Comments



    Interested persons may submit to the Division of Dockets Management 

(see ADDRESSES) either electronic or written comments regarding this 

document. It is only necessary to send one set of comments. It is no 

longer necessary to send two copies of mailed comments. Identify 

comments with the docket number found in brackets in the heading of 

this document. Received comments may be seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., Monday through Friday.



IV. Electronic Access



    An electronic version of this guidance document is available on the 

Internet at https://www.regulations.gov and https://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.



    Dated: June 4, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.

[FR Doc. 2010-13819 Filed 6-4-10; 4:15 pm]

BILLING CODE 4160-01-S
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