Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products; Correction, 30506-30507 [2014-12296]

Download as PDF 30506 Federal Register / Vol. 79, No. 102 / Wednesday, May 28, 2014 / Proposed Rules and place of filing reports, will be published by the Director of the Bureau of Economic Analysis in the Federal Register prior to the implementation of a survey; (b) In accordance with section 3104(b)(2) of title 22 of the United States Code, persons notified of these surveys and subject to the jurisdiction of the United States shall furnish, under oath, any report containing information which is determined to be necessary to carry out the surveys and studies provided for by the Act; and (c) Persons not notified in writing of their filing obligation by the Bureau of Economic Analysis are not required to complete the survey. ■ 3. Revise § 801.4 to read as follows: § 801.4 Recordkeeping requirements. In accordance with section 3104(b)(1) of title 22 of the United States Code, persons subject to the jurisdiction of the United States shall maintain any information which is essential for carrying out the surveys and studies provided for by the Act. ■ 4. Amend § 801.7 to read as follows: mstockstill on DSK4VPTVN1PROD with PROPOSALS § 801.7 Rules and regulations for the BE– 13, Survey of New Foreign Direct Investment in the United States. The BE–13, Survey of New Foreign Direct Investment in the United States is conducted to collect data on the acquisition or establishment of U.S. business enterprises by foreign investors and the expansion of existing U.S. affiliates of foreign companies to establish a new production facility. All legal authorities, provisions, definitions, and requirements contained in §§ 801.1 through 801.2 and §§ 801.4 through 801.6 are applicable to this survey. Specific additional rules and regulations for the BE–13 survey are given in paragraphs (a) through (d) of this section. More detailed instructions are given on the report forms and instructions. (a) Response required. A response is required from persons subject to the reporting requirements of the BE–13, Survey of New Foreign Direct Investment in the United States, contained herein, whether or not they are contacted by BEA. Also, a person, or their agent, that is contacted by BEA about reporting in this survey, either by sending them a report form or by written inquiry, must respond in writing pursuant this section. This may be accomplished by filing the properly completed BE–13 report (BE–13A, BE– 13B, BE–13C, BE–13D, BE–13E, or BE– 13 Claim for Exemption) within 45 days of being contacted. VerDate Mar<15>2010 16:35 May 27, 2014 Jkt 232001 (b) Who must report. A BE–13 report is required of any U.S. company in which: (1) A foreign direct investment in the United States relationship is created; (2) An existing U.S. affiliate of a foreign parent establishes a new U.S. legal entity, expands its U.S. operations, or acquires a U.S. business enterprise, or; (3) A U.S. business enterprise that previously filed a BE–13B or BE–13D indicating that the established or expanded entity is still under construction. Foreign direct investment is defined as the ownership or control by one foreign person (foreign parent) of 10 percent or more of the voting securities of an incorporated U.S. business enterprise, or an equivalent interest of an unincorporated U.S. business enterprise, including a branch. (c) Forms to be filed. Depending on the type of investment transaction, U.S. affiliates would report their information, on one of six forms—BE–13A, BE–13B, BE–13C, BE–13D, BE–13E, or BE–13 Claim for Exemption. (1) Form BE–13A—Report for a U.S. business enterprise when a foreign entity acquires a voting interest (directly, or indirectly through an existing U.S. affiliate) in that enterprise, segment, or operating unit and: (i) The total cost of the acquisition is greater than $3 million; (ii) The U.S. business enterprise will operate as a separate legal entity, and; (iii) By this acquisition, at least 10 percent of the voting interest in the acquired entity is now held (directly or indirectly) by the foreign entity. (2) Form BE–13B—Report for a U.S. business enterprise when a foreign entity, or an existing U.S. affiliate of a foreign entity, establishes a new legal entity in the United States and: (i) The projected total cost to establish the new legal entity is greater than $3 million, and; (ii) The foreign entity owns 10 percent or more of the new business enterprise’s voting interest (directly or indirectly). (3) Form BE–13C—Report for an existing U.S. affiliate of a foreign parent when it acquires a U.S. business enterprise or segment that it then merges into its operations and the total cost to acquire the business enterprise is greater than $3 million. (4) Form BE–13D—Report for an existing U.S. affiliate of a foreign parent when it expands its operations to include a new facility where business is conducted and the projected total cost of the expansion is greater than $3 million. (5) Form BE–13E—Report for a U.S. business enterprise that previously filed PO 00000 Frm 00022 Fmt 4702 Sfmt 4702 a BE–13B or BE–13D indicating that the established or expanded entity is still under construction. This form will collect updated cost information and will be collected annually until construction is complete. (6) Form BE–13 Claim for Not Filing— Report for a U.S. business enterprise that: (i) was contacted by BEA but does not meet the requirements for filing forms BE–13A, BE–13B, BE–13C, or BE–13D; or (ii) whether or not contacted by BEA, met all requirements for filing on Forms BE–13A, BE–13B, BE–13C, or BE–13D except the $3 million reporting threshold. (d) Due date. The BE–13 forms are due no later than 45 days after the acquisition is completed, the new legal entity is established, the expansion is begun, or the cost update is requested. [FR Doc. 2014–12159 Filed 5–27–14; 8:45 am] BILLING CODE 3510–06–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 1100, 1140, and 1143 [Docket No. FDA–2014–N–0189] RIN 0910–AG38 Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule; correction. The Food and Drug Administration (FDA or we) is correcting the preamble to a proposed rule that appeared in the Federal Register of April 25, 2014. That proposed rule would deem products meeting the statutory definition of ‘‘tobacco product,’’ except accessories of a proposed deemed tobacco product, to be subject to the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). The Tobacco Control Act provides FDA authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any other tobacco products SUMMARY: E:\FR\FM\28MYP1.SGM 28MYP1 Federal Register / Vol. 79, No. 102 / Wednesday, May 28, 2014 / Proposed Rules that the Agency by regulation deems to be subject to the law. Option 1 of the proposed rule would extend the Agency’s ‘‘tobacco product’’ authorities in the FD&C Act to all other categories of products, except accessories of a proposed deemed tobacco product, that meet the statutory definition of ‘‘tobacco product’’ in the FD&C Act. Option 2 of the proposed rule would extend the Agency’s ‘‘tobacco product’’ authorities to all other categories of products, except premium cigars and the accessories of a proposed deemed tobacco product, that meet the statutory definition of ‘‘tobacco product’’ in the FD&C Act. FDA also is proposing to prohibit the sale of ‘‘covered tobacco products’’ to individuals under the age of 18 and to require the display of health warnings on cigarette tobacco, roll-your own tobacco, and covered tobacco product packages and in advertisements. FDA is taking this action to address the public health concerns associated with the use of tobacco products. The document published with several technical errors, including some errors in reference numbers cited in section VII.B. of the document. This document corrects those errors. We are placing a corrected copy of the proposed rule in the docket. The proposed rule published April 25, 2014 (79 FR 23141) is corrected as of May 28, 2014. DATES: FOR FURTHER INFORMATION CONTACT: Gerie Voss, Office of Regulations, Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850–3229, 877–287– 1373, CTPRegulations@fda.hhs.gov. FDA is correcting the preamble to the April 25, 2014 (79 FR 23141), proposed rule entitled ‘‘Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products.’’ We are correcting references 2, 92, and 151– 157 in the reference list and in section VII.B. We are also placing a corrected copy of the proposed rule in the docket. In FR Doc. 2014–09491, appearing on page 23141 in the Federal Register of Friday, April 25, 2014 (79 FR 23141), FDA is making the following corrections: 1. On page 23165, in the first column, ‘‘(Refs.154, 155, and 156)’’ is corrected to read ‘‘(Refs. 154, 154A, and 155).’’ mstockstill on DSK4VPTVN1PROD with PROPOSALS SUPPLEMENTARY INFORMATION: VerDate Mar<15>2010 16:35 May 27, 2014 Jkt 232001 2. On page 23165, in the first column, ‘‘(Ref. 155)’’ is corrected to read ‘‘(Ref. 154A).’’ 3. On page 23165, in the second column, ‘‘(Ref. 156)’’ is corrected to read ‘‘(Ref. 155).’’ 4. On page 23165, in the second column ‘‘(Ref. 159 at 11)’’ is corrected to read, ‘‘(Ref. 158 at 11).’’ 5. On page 23165, in the second column, ‘‘(Ref. 159 at 12)’’ is corrected to read ‘‘(Ref. 158 at 12).’’ 6. On page 23197, in the third column, reference 2 is corrected to read: ‘‘2. Arrazola, R.A., N.M. Kuiper, and S.R. Dube, ‘‘Patterns of Current Use of Tobacco Products Among U.S. High School Students for 2000–2012— Findings From the National Youth Tobacco Survey,’’ Journal of Adolescent Health, 54:54–60, 2013.’’ 7. On page 23200, in the first column, reference 92 is corrected to read: ‘‘92. Cobb, C.O., K. Sahmarani, T. Eissenberg, et al., ‘‘Acute Toxicant Exposure and Cardiac Autonomic Dysfunction From Smoking a Single Narghile Waterpipe With Tobacco and With a ‘Healthy’ Tobacco-Free Alternative,’’ Toxicology Letters, 215:70–75, 2012.’’ 8. On page 23201, in the second column, the second reference 151 is corrected to read: ‘‘152. Portillo, F. and ˜ F. Antonanzas, ‘‘Information Disclosure and Smoking Risk Perceptions: Potential Short-Term Impact on Spanish Students of the New European Union Directive on Tobacco Products,’’ European Journal of Public Health, 12:295–301, 2002.’’ 9. On page 23201, in the second column, reference 152 is corrected to read: ‘‘153. Hammond, D., G.T. Fong, R. Borland, et al., ‘‘Effectiveness of Cigarette Warning Labels in Informing Smokers About the Risks of Smoking: Findings From the International Tobacco Control (ITC) Four Country Survey,’’ Tobacco Control, 15(Supp III):iii19–iii25, 2006.’’ 10. On page 23201, in the second column, reference 153 is corrected to read: ‘‘154. Fischer, P.M., J.W. Richards Jr., E.J. Berman, and D.M. Krugman, ‘‘Recall and Eye Tracking Study of Adolescents Viewing Tobacco Advertisements,’’ Journal of the American Medical Association, 261(1):84–89, 1989.’’ 11. On page 23201, in the third column, reference 154 is corrected to read: ‘‘154A. Krugman, D.M., R.J. Fox, J.E. Fletcher, et al., ‘‘Do Adolescents Attend to Warnings in Cigarette Advertising: An Eye-Tracking Approach,’’ Journal of Advertising Research, 34(6):39–52, 1994.’’ 12. On page 23201, in the third column, reference 157 is corrected to PO 00000 Frm 00023 Fmt 4702 Sfmt 4702 30507 read: ‘‘156. Truitt, L., W.L. Hamilton, P.R. Johnston, et al., ‘‘Recall of Health Warnings in Smokeless Tobacco Ads,’’ Tobacco Control, 11(Supp II): ii59–ii63, 2002.’’ 13. On page 23201, in the third column, reference 156 is corrected to read: ‘‘157. MacKinnon, D.P. and A.M. Fenaughty, ‘‘Substance Use and Memory for Health Warning Labels,’’ Health Psychology, 12(2):147–150, 1993.’’ Dated: May 21, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–12296 Filed 5–27–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF TRANSPORTATION Federal Highway Administration 23 CFR Part 490 [FHWA Docket No. FHWA–2013–0020] RIN 2125–AF49 National Performance Management Measures; Highway Safety Improvement Program Federal Highway Administration (FHWA), DOT. ACTION: Notice of proposed rulemaking; extension of comment period. AGENCY: The FHWA is extending the comment period for a notice of proposed rulemaking (NPRM) and request for comments, which was published on March 11, 2014, at 79 FR 13846. The original comment period is set to close on June 9, 2014. The extension is based the FHWA’s desire to allow interested parties sufficient time to review and provide comprehensive comments on this NPRM and the related FHWA/FTA Statewide and Nonmetropolitan Transportation Planning; Metropolitan Transportation Planning NPRM (FHWA RIN 2125– AF52; FTA RIN 2132–AB10). Therefore, the closing date for comments is changed to June 30, 2014, which will provide those interested in commenting additional time to discuss, evaluate, and submit responses to the docket. DATES: Comments must be received on or before June 30, 2014. ADDRESSES: Mail or hand deliver comments to the U.S. Department of Transportation, Dockets Management Facility, 1200 New Jersey Avenue SE., Washington, DC 20590, or submit electronically at https:// www.regulations.gov. All comments should include the docket number that SUMMARY: E:\FR\FM\28MYP1.SGM 28MYP1

Agencies

[Federal Register Volume 79, Number 102 (Wednesday, May 28, 2014)]
[Proposed Rules]
[Pages 30506-30507]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-12296]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1100, 1140, and 1143

[Docket No. FDA-2014-N-0189]
RIN 0910-AG38


Deeming Tobacco Products To Be Subject to the Federal Food, Drug, 
and Cosmetic Act, as Amended by the Family Smoking Prevention and 
Tobacco Control Act; Regulations on the Sale and Distribution of 
Tobacco Products and Required Warning Statements for Tobacco Products; 
Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; correction.

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

SUMMARY: The Food and Drug Administration (FDA or we) is correcting the 
preamble to a proposed rule that appeared in the Federal Register of 
April 25, 2014. That proposed rule would deem products meeting the 
statutory definition of ``tobacco product,'' except accessories of a 
proposed deemed tobacco product, to be subject to the Federal Food, 
Drug, and Cosmetic Act (the FD&C Act), as amended by the Family Smoking 
Prevention and Tobacco Control Act (Tobacco Control Act). The Tobacco 
Control Act provides FDA authority to regulate cigarettes, cigarette 
tobacco, roll-your-own tobacco, smokeless tobacco, and any other 
tobacco products

[[Page 30507]]

that the Agency by regulation deems to be subject to the law. Option 1 
of the proposed rule would extend the Agency's ``tobacco product'' 
authorities in the FD&C Act to all other categories of products, except 
accessories of a proposed deemed tobacco product, that meet the 
statutory definition of ``tobacco product'' in the FD&C Act. Option 2 
of the proposed rule would extend the Agency's ``tobacco product'' 
authorities to all other categories of products, except premium cigars 
and the accessories of a proposed deemed tobacco product, that meet the 
statutory definition of ``tobacco product'' in the FD&C Act. FDA also 
is proposing to prohibit the sale of ``covered tobacco products'' to 
individuals under the age of 18 and to require the display of health 
warnings on cigarette tobacco, roll-your own tobacco, and covered 
tobacco product packages and in advertisements. FDA is taking this 
action to address the public health concerns associated with the use of 
tobacco products.
    The document published with several technical errors, including 
some errors in reference numbers cited in section VII.B. of the 
document. This document corrects those errors. We are placing a 
corrected copy of the proposed rule in the docket.

DATES: The proposed rule published April 25, 2014 (79 FR 23141) is 
corrected as of May 28, 2014.

FOR FURTHER INFORMATION CONTACT: Gerie Voss, Office of Regulations, 
Center for Tobacco Products, Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850-3229, 877-287-1373, 
CTPRegulations@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: FDA is correcting the preamble to the April 
25, 2014 (79 FR 23141), proposed rule entitled ``Deeming Tobacco 
Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as 
Amended by the Family Smoking Prevention and Tobacco Control Act; 
Regulations on the Sale and Distribution of Tobacco Products and 
Required Warning Statements for Tobacco Products.'' We are correcting 
references 2, 92, and 151-157 in the reference list and in section 
VII.B. We are also placing a corrected copy of the proposed rule in the 
docket.
    In FR Doc. 2014-09491, appearing on page 23141 in the Federal 
Register of Friday, April 25, 2014 (79 FR 23141), FDA is making the 
following corrections:
    1. On page 23165, in the first column, ``(Refs.154, 155, and 156)'' 
is corrected to read ``(Refs. 154, 154A, and 155).''
    2. On page 23165, in the first column, ``(Ref. 155)'' is corrected 
to read ``(Ref. 154A).''
    3. On page 23165, in the second column, ``(Ref. 156)'' is corrected 
to read ``(Ref. 155).''
    4. On page 23165, in the second column ``(Ref. 159 at 11)'' is 
corrected to read, ``(Ref. 158 at 11).''
    5. On page 23165, in the second column, ``(Ref. 159 at 12)'' is 
corrected to read ``(Ref. 158 at 12).''
    6. On page 23197, in the third column, reference 2 is corrected to 
read: ``2. Arrazola, R.A., N.M. Kuiper, and S.R. Dube, ``Patterns of 
Current Use of Tobacco Products Among U.S. High School Students for 
2000-2012--Findings From the National Youth Tobacco Survey,'' Journal 
of Adolescent Health, 54:54-60, 2013.''
    7. On page 23200, in the first column, reference 92 is corrected to 
read: ``92. Cobb, C.O., K. Sahmarani, T. Eissenberg, et al., ``Acute 
Toxicant Exposure and Cardiac Autonomic Dysfunction From Smoking a 
Single Narghile Waterpipe With Tobacco and With a `Healthy' Tobacco-
Free Alternative,'' Toxicology Letters, 215:70-75, 2012.''
    8. On page 23201, in the second column, the second reference 151 is 
corrected to read: ``152. Portillo, F. and F. Anto[ntilde]anzas, 
``Information Disclosure and Smoking Risk Perceptions: Potential Short-
Term Impact on Spanish Students of the New European Union Directive on 
Tobacco Products,'' European Journal of Public Health, 12:295-301, 
2002.''
    9. On page 23201, in the second column, reference 152 is corrected 
to read: ``153. Hammond, D., G.T. Fong, R. Borland, et al., 
``Effectiveness of Cigarette Warning Labels in Informing Smokers About 
the Risks of Smoking: Findings From the International Tobacco Control 
(ITC) Four Country Survey,'' Tobacco Control, 15(Supp III):iii19-iii25, 
2006.''
    10. On page 23201, in the second column, reference 153 is corrected 
to read: ``154. Fischer, P.M., J.W. Richards Jr., E.J. Berman, and D.M. 
Krugman, ``Recall and Eye Tracking Study of Adolescents Viewing Tobacco 
Advertisements,'' Journal of the American Medical Association, 
261(1):84-89, 1989.''
    11. On page 23201, in the third column, reference 154 is corrected 
to read: ``154A. Krugman, D.M., R.J. Fox, J.E. Fletcher, et al., ``Do 
Adolescents Attend to Warnings in Cigarette Advertising: An Eye-
Tracking Approach,'' Journal of Advertising Research, 34(6):39-52, 
1994.''
    12. On page 23201, in the third column, reference 157 is corrected 
to read: ``156. Truitt, L., W.L. Hamilton, P.R. Johnston, et al., 
``Recall of Health Warnings in Smokeless Tobacco Ads,'' Tobacco 
Control, 11(Supp II): ii59-ii63, 2002.''
    13. On page 23201, in the third column, reference 156 is corrected 
to read: ``157. MacKinnon, D.P. and A.M. Fenaughty, ``Substance Use and 
Memory for Health Warning Labels,'' Health Psychology, 12(2):147-150, 
1993.''

    Dated: May 21, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-12296 Filed 5-27-14; 8:45 am]
BILLING CODE 4160-01-P

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