Guidance for Tobacco Retailers on Tobacco Retailer Training Programs; Availability, 54657-54658 [2013-21547]

Download as PDF ehiers on DSK2VPTVN1PROD with NOTICES Federal Register / Vol. 78, No. 172 / Thursday, September 5, 2013 / Notices clinical data) was $224,352,000. (Note: no investigational new drug (IND) review costs are included in this amount.) A total of 18 of these applications (12 NDAs [excluding the President’s Emergency Plan for Aids Relief NDAs] and 6 BLAs) received priority review, which would mean that the remaining 36 received standard reviews. Because a priority review compresses a review that ordinarily takes 10 months into 6 months, FDA estimates that a multiplier of 1.67 (10 months divided by 6 months) should be applied to non-priority review costs in estimating the effort and cost of a priority review as compared to a standard review. This multiplier is consistent with published research on this subject. In the article ‘‘Developing Drugs for Developing Countries,’’ published in Health Affairs, Volume 25, Number 2, in 2006, the comparison of historical average review times by David B. Ridley, Henry G. Grabowski, and Jeffrey L. Moe supports a priority review multiplier in the range of 1.48 to 2.35. The multiplier derived by FDA falls well below the midpoint of this range. Using FY 2012 figures, the costs of a priority and standard review are estimated using the following formula: (18 a × 1.67) + (36 a) = $224,352,000 where ‘‘a’’ is the cost of a standard review and ‘‘a times 1.67’’ is the cost of a priority review. Using this formula, the cost of a standard review for NMEs is calculated to be $3,396,000 (rounded to the nearest thousand dollars) and the cost of a priority review for NMEs is 1.67 times that amount, or $5,671,000 (rounded to the nearest thousand dollars). The difference between these two cost estimates, or $2,275,000, represents the incremental cost of conducting a priority review rather than a standard review. Section 524 of the FD&C Act specifies that the fee amount should be based on the average cost incurred by the Agency for a priority review in the previous FY. FDA is setting fees for FY 2014, and the previous fiscal year is FY 2013. However, the FY 2013 submission cohort has not been closed out yet, and the cost data for FY 2013 are not complete. The latest year for which FDA has complete cost data is FY 2012, so that must be adjusted for inflation in order to estimate the FY 2013 cost. Accordingly, FDA will adjust the FY 2012 incremental cost figure by the average amount by which FDA’s average costs increased in the 3 years prior to FY 2013, to adjust the FY 2012 amount for cost increases in FY 2013. That figure, published in the Federal Register notice on August 2, 2013 (see 78 FR VerDate Mar<15>2010 14:10 Sep 04, 2013 Jkt 229001 46980 at 46982), setting PDUFA fees for FY 2014, is 2.20 percent. Increasing the FY 2012 incremental priority review cost figure of $2,275,000 by 2.20 percent results in an estimated cost of $2,325,000 (rounded to the nearest thousand dollars). This is the priority review user fee amount for FY 2014 that must be submitted with a priority review voucher in FY 2014, in addition to any PDUFA fee that is required for such an application. III. Priority Review Fee Schedule for FY 2014 The fee rate for FY 2014 is set out in Table 1 of this document: TABLE 1—PRIORITY REVIEW SCHEDULE FOR FY 2014 Fee category Fee rate for FY 2014 Applications Submitted with a Priority Review Voucher in Addition to the Normal PDUFA Fee ....................... $2,325,000 IV. Implementation of Priority Review Fee Under section 524(c)(4)(A) of the FD&C Act, the priority review user fee is due upon submission of the application for which the priority review voucher is used. Section 524(c)(4)(B) of the FD&C Act specifies that the application will be considered incomplete if the priority review user fee and all other applicable user fees are not paid in accordance with FDA payment procedures. FDA may not grant a waiver, exemption, reduction, or refund of any fees due and payable under this section of the FD&C Act, and FDA may not collect priority review voucher fees prior to a relevant appropriation for fees for that FY. Beginning with FDA’s appropriation for FY 2009, the annual appropriation language states specifically that ‘‘priority review user fees authorized by 21 U.S.C. 360n [section 524 of the FD&C Act] may be credited to this account, to remain available until expended.’’ (Pub. L. 111–8, Section 5, Division A, Title VI.) The priority review fee established in the new fee schedule must be paid for any application that is received after September 30, 2013, and submitted with a priority review voucher. This fee must be paid in addition to any other fee due under PDUFA. Payment must be made in U.S. currency by check, bank draft, or U.S. postal money order payable to the order of the Food and Drug Administration. The user fee identification (ID) number should be PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 54657 included on the check, followed by the words ‘‘Priority Review.’’ Payments can be mailed to: Food and Drug Administration, P.O. Box 979107, St. Louis, MO 63197–9000. If checks are sent by a courier that requests a street address, the courier can deliver the checks to: U.S. Bank, Attention: Government Lockbox 979107, 1005 Convention Plaza, St. Louis, MO 63101. (Note: This U.S. Bank address is for courier delivery only.) The FDA post office box number (P.O. Box 979107) must be written on the check. The tax identification number of FDA is 53– 0196965. Wire transfer payments may also be used. Please reference your unique user fee ID number when completing your transfer. The originating financial institution may charge a wire transfer fee. Please ask your financial institution about the fee and include it with your payment to ensure that your fee is fully paid. The account information is as follows: New York Federal Reserve Bank, U.S. Dept. of Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, Acct. No.: 75060099, Routing No.: 021030004, SWIFT: FRNYUS33, Beneficiary: FDA, 1350 Piccard Dr., Rockville, MD 20850. Dated: August 29, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–21542 Filed 9–4–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–D–0350] Guidance for Tobacco Retailers on Tobacco Retailer Training Programs; 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 ‘‘Tobacco Retailer Training Programs.’’ The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) does not require retailers to implement retailer training programs. However, the Tobacco Control Act does provide for lower civil money penalties for violations of sale and distribution, including youth access, advertising, and promotion restrictions issued under the Federal Food, Drug, and Cosmetic Act SUMMARY: E:\FR\FM\05SEN1.SGM 05SEN1 54658 Federal Register / Vol. 78, No. 172 / Thursday, September 5, 2013 / Notices ehiers on DSK2VPTVN1PROD with NOTICES (the FD&C Act), as amended by the Tobacco Control Act, for retailers who have implemented a training program that complies with standards developed by FDA for such programs. FDA intends to issue regulations establishing standards for approved retailer training programs. In the interim, this guidance document is intended to assist tobacco retailers who wish to implement training programs for employees. 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 this guidance 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 document may be sent. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments on the guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Beth Buckler, Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850– 3229, 1–877–287–1373, beth.buckler@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for tobacco retailers entitled ‘‘Tobacco Retailer Training Programs.’’ This guidance document is intended to assist tobacco retailers who wish to implement training programs for employees. On June 22, 2009, the President signed the Tobacco Control Act (Pub. L. 111–31; 123 Stat. 1776) into law. The Tobacco Control Act grants FDA important authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health generally and to reduce tobacco use by minors. Among its many provisions, section 906(d) of the FD&C Act (21 U.S.C. 387f(d)), as amended by the Tobacco Control Act, states that ‘‘[t]he Secretary may by regulation require restrictions on the sale and distribution of a tobacco product, including restrictions on the access to, and the advertising and VerDate Mar<15>2010 14:10 Sep 04, 2013 Jkt 229001 promotion of, the tobacco product, if the Secretary determines that such regulation would be appropriate for the protection of the public health.’’ In accordance with section 102 of the Tobacco Control Act (21 U.S.C. 387a-1), FDA re-issued its 1996 final regulation restricting the sale and distribution of cigarettes and smokeless tobacco products (75 FR 13225, March 19, 2010). The regulation is deemed to be issued under chapter 9 of the FD&C Act, as amended by the Tobacco Control Act (section 102(a)(1)(A) of the Tobacco Control Act). The regulation contains provisions designed to limit young people’s access to cigarettes and smokeless tobacco products, as well as restrictions on advertising and promotion of such products, to curb the appeal of these products to minors (part 1140 (21 CFR part 1140)). Section 103(q)(2) of the Tobacco Control Act (21 U.S.C. 333 note) includes two schedules for assessing the maximum civil money penalties against retailers for violations of restrictions issued under section 906(d) of the FD&C Act, as amended by the Tobacco Control Act, pertaining to the sale and distribution, including youth access, and advertising and promotion of tobacco products. Under each schedule, violators are subject to increasing penalties for multiple violations within prescribed time periods. For the first three violations in a 24-month period, retailers with an approved training program are subject to lower penalties than retailers without such programs. Section 103(q)(2)(B) defines ‘‘approved training program’’ as a training program that complies with standards developed by FDA for such programs. FDA intends to issue regulations establishing standards for approved retailer training programs. In the interim, however, FDA is issuing this guidance to provide recommendations on elements the Agency believes should be included in a retailer training program. Until FDA issues these regulations, the Agency intends to use the lower maximum civil money penalties schedule for all retailers who violate the regulations restricting the sale and distribution of cigarettes and smokeless tobacco products (part 1140), whether or not they have implemented a training program. However, FDA may consider further reducing the civil money penalty for retailers who have implemented a training program. In the Federal Register of July 16, 2010 (75 FR 41498), FDA announced the availability of a draft guidance entitled ‘‘Tobacco Retailer Training Programs.’’ The Agency considered received comments as it finalized this guidance. PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 In addition, editorial changes were made to improve clarity. II. Significance of Guidance This level 1 guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency’s current thinking on tobacco retailer training programs. 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. III. Comments Interested persons may submit either written comments regarding this document to the Division of Dockets Management (see ADDRESSES) or electronic comments to https:// www.regulations.gov. 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. 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. IV. Paperwork Reduction Act of 1995 This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collection of information in this guidance was approved under OMB control number 0910–0745. V. Electronic Access Persons with access to the Internet may obtain the document at either https://www.regulations.gov or https:// www.fda.gov/TobaccoProducts/ GuidanceComplianceRegulatory Information/default.htm. Dated: August 30, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–21547 Filed 9–4–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0001] Allergenic Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. E:\FR\FM\05SEN1.SGM 05SEN1

Agencies

[Federal Register Volume 78, Number 172 (Thursday, September 5, 2013)]
[Notices]
[Pages 54657-54658]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-21547]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0350]


Guidance for Tobacco Retailers on Tobacco Retailer Training 
Programs; 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 ``Tobacco 
Retailer Training Programs.'' The Family Smoking Prevention and Tobacco 
Control Act (Tobacco Control Act) does not require retailers to 
implement retailer training programs. However, the Tobacco Control Act 
does provide for lower civil money penalties for violations of sale and 
distribution, including youth access, advertising, and promotion 
restrictions issued under the Federal Food, Drug, and Cosmetic Act

[[Page 54658]]

(the FD&C Act), as amended by the Tobacco Control Act, for retailers 
who have implemented a training program that complies with standards 
developed by FDA for such programs. FDA intends to issue regulations 
establishing standards for approved retailer training programs. In the 
interim, this guidance document is intended to assist tobacco retailers 
who wish to implement training programs for employees.

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 this guidance 
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 document may be sent. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.
    Submit electronic comments on the guidance to https://www.regulations.gov. Submit written comments on the guidance to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beth Buckler, Center for Tobacco 
Products, Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850-3229, 1-877-287-1373, beth.buckler@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for tobacco 
retailers entitled ``Tobacco Retailer Training Programs.'' This 
guidance document is intended to assist tobacco retailers who wish to 
implement training programs for employees.
    On June 22, 2009, the President signed the Tobacco Control Act 
(Pub. L. 111-31; 123 Stat. 1776) into law. The Tobacco Control Act 
grants FDA important authority to regulate the manufacture, marketing, 
and distribution of tobacco products to protect the public health 
generally and to reduce tobacco use by minors.
    Among its many provisions, section 906(d) of the FD&C Act (21 
U.S.C. 387f(d)), as amended by the Tobacco Control Act, states that 
``[t]he Secretary may by regulation require restrictions on the sale 
and distribution of a tobacco product, including restrictions on the 
access to, and the advertising and promotion of, the tobacco product, 
if the Secretary determines that such regulation would be appropriate 
for the protection of the public health.''
    In accordance with section 102 of the Tobacco Control Act (21 
U.S.C. 387a-1), FDA re-issued its 1996 final regulation restricting the 
sale and distribution of cigarettes and smokeless tobacco products (75 
FR 13225, March 19, 2010). The regulation is deemed to be issued under 
chapter 9 of the FD&C Act, as amended by the Tobacco Control Act 
(section 102(a)(1)(A) of the Tobacco Control Act). The regulation 
contains provisions designed to limit young people's access to 
cigarettes and smokeless tobacco products, as well as restrictions on 
advertising and promotion of such products, to curb the appeal of these 
products to minors (part 1140 (21 CFR part 1140)).
    Section 103(q)(2) of the Tobacco Control Act (21 U.S.C. 333 note) 
includes two schedules for assessing the maximum civil money penalties 
against retailers for violations of restrictions issued under section 
906(d) of the FD&C Act, as amended by the Tobacco Control Act, 
pertaining to the sale and distribution, including youth access, and 
advertising and promotion of tobacco products. Under each schedule, 
violators are subject to increasing penalties for multiple violations 
within prescribed time periods. For the first three violations in a 24-
month period, retailers with an approved training program are subject 
to lower penalties than retailers without such programs. Section 
103(q)(2)(B) defines ``approved training program'' as a training 
program that complies with standards developed by FDA for such 
programs.
    FDA intends to issue regulations establishing standards for 
approved retailer training programs. In the interim, however, FDA is 
issuing this guidance to provide recommendations on elements the Agency 
believes should be included in a retailer training program. Until FDA 
issues these regulations, the Agency intends to use the lower maximum 
civil money penalties schedule for all retailers who violate the 
regulations restricting the sale and distribution of cigarettes and 
smokeless tobacco products (part 1140), whether or not they have 
implemented a training program. However, FDA may consider further 
reducing the civil money penalty for retailers who have implemented a 
training program.
    In the Federal Register of July 16, 2010 (75 FR 41498), FDA 
announced the availability of a draft guidance entitled ``Tobacco 
Retailer Training Programs.'' The Agency considered received comments 
as it finalized this guidance. In addition, editorial changes were made 
to improve clarity.

II. Significance of Guidance

    This level 1 guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The guidance represents 
the Agency's current thinking on tobacco retailer training programs. 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.

III. Comments

    Interested persons may submit either written comments regarding 
this document to the Division of Dockets Management (see ADDRESSES) or 
electronic comments to https://www.regulations.gov. 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. 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.

IV. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collection of information in this guidance was approved under OMB 
control number 0910-0745.

V. Electronic Access

    Persons with access to the Internet may obtain the document at 
either https://www.regulations.gov or https://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.

    Dated: August 30, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-21547 Filed 9-4-13; 8:45 am]
BILLING CODE 4160-01-P
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