81 FR 28783 - Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products; Small Entity Compliance Guide; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 90 (May 10, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 90 (May 10, 2016)
| Page Range | 28783-28784 | |
| FR Document | 2016-10689 |
[Federal Register Volume 81, Number 90 (Tuesday, May 10, 2016)] [Proposed Rules] [Pages 28783-28784] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-10689] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1150 [Docket No. FDA-2014-D-0917] Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products; Small Entity Compliance Guide; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a revised guidance for industry entitled ``Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products; Small Entity Compliance Guide'' for the final user fees rule published July 10, 2014, and for the new user fees regulation. This revised guidance, a small entity compliance guide (SECG), replaces the SECG of the same name published on July 16, 2014. The revised SECG is intended to set forth in plain language the requirements of the user fee regulations and to help small businesses understand and comply with the regulations. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2014-D-0917 for ``Small Entity Compliance Guide: Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of this guidance to the Center for Tobacco Products, Food and Drug Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., 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 document may be sent. See the [[Page 28784]] SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. FOR FURTHER INFORMATION CONTACT: Paul Hart, Center for Tobacco Products, Food and Drug Administration, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993, 1-877-287-1373, email: [email protected]. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a revised guidance for industry entitled ``Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products; Small Entity Compliance Guide'' for the final user fee rules published July 10, 2014 (79 FR 39302). Also, published elsewhere in this edition of the Federal Register, FDA issued a final rule to amend 21 CFR part 1150 (part 1150) to require domestic manufacturers and importers of cigars and pipe tobacco to submit to FDA information needed to calculate the amount of user fees assessed under the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA issued this user fee final rule together with the final rule, ``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; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products'' (Deeming rule), which deems all products that meet the statutory definition of ``tobacco product,'' except accessories of the newly deemed tobacco products, to be subject to the FD&C Act. The Deeming rule, among other things, subjects domestic manufacturers and importers of cigars and pipe tobacco to the FD&C Act's user fee requirements. Consistent with the Deeming rule and the requirements of the FD&C Act, this user fee final rule requires the submission of the information needed to calculate user fee assessments for each manufacturer and importer of cigars and pipe tobacco to FDA. In compliance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Pub. L. 104-121), FDA is making available this revised SECG stating in plain language the legal requirements of the user fee final regulations set forth in part 1150. II. Significance of Guidance FDA is issuing this revised SECG as a level 2 guidance, consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public unless specific regulatory or statutory requirements are cited. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. III. 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/Labeling/RulesRegulationsGuidance/default.htm. Dated: May 3, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-10689 Filed 5-5-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 90 / Tuesday, May 10, 2016 / Proposed Rules 28783
practices regulation (21 CFR 10.115). regulation. This revised guidance, a Calculate User Fees for Domestic
The draft guidance, when finalized, will small entity compliance guide (SECG), Manufacturers and Importers of Tobacco
represent the current thinking of FDA replaces the SECG of the same name Products.’’ Received comments will be
on PMTAs for ENDS. It does not published on July 16, 2014. The revised placed in the docket and, except for
establish any rights for any person and SECG is intended to set forth in plain those submitted as ‘‘Confidential
is not binding on FDA or the public. language the requirements of the user Submissions,’’ publicly viewable at
You can use an alternative approach if fee regulations and to help small http://www.regulations.gov or at the
it satisfies the requirements of the businesses understand and comply with Division of Dockets Management
applicable statutes and regulations. the regulations. between 9 a.m. and 4 p.m., Monday
DATES: Submit either electronic or through Friday.
III. Paperwork Reduction Act of 1995 • Confidential Submissions—To
written comments on Agency guidances
This draft guidance refers to submit a comment with confidential
at any time.
collections of information described in information that you do not wish to be
FDA’s Deeming rule, which this draft ADDRESSES: You may submit comments
made publicly available, submit your
guidance is intended to interpret. The as follows: comments only as a written/paper
collections of information in the Electronic Submissions submission. You should submit two
Deeming rule are subject to review by copies total. One copy will include the
the Office of Management and Budget Submit electronic comments in the
information you claim to be confidential
(OMB) under the Paperwork Reduction following way: with a heading or cover note that states
Act of 1995 (PRA) (44 U.S.C. 3501– • Federal eRulemaking Portal: http:// ‘‘THIS DOCUMENT CONTAINS
3520). As required by the PRA, FDA has www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
published an analysis of the information instructions for submitting comments. Agency will review this copy, including
collection provisions elsewhere in this Comments submitted electronically, the claimed confidential information, in
issue of the Federal Register and has including attachments, to http:// its consideration of comments. The
submitted them for OMB approval. www.regulations.gov will be posted to second copy, which will have the
the docket unchanged. Because your claimed confidential information
IV. Electronic Access comment will be made public, you are redacted/blacked out, will be available
Persons with access to the Internet solely responsible for ensuring that your for public viewing and posted on http://
may obtain an electronic version of the comment does not include any www.regulations.gov. Submit both
draft guidance at either http:// confidential information that you or a copies to the Division of Dockets
www.regulations.gov or http:// third party may not wish to be posted, Management. If you do not wish your
www.fda.gov/TobaccoProducts/ such as medical information, your or name and contact information to be
Labeling/RulesRegulationsGuidance/ anyone else’s Social Security number, or made publicly available, you can
default.htm. confidential business information, such provide this information on the cover
as a manufacturing process. Please note sheet and not in the body of your
Dated: May 3, 2016.
that if you include your name, contact comments and you must identify this
Leslie Kux,
information, or other information that information as ‘‘confidential.’’ Any
Associate Commissioner for Policy. identifies you in the body of your information marked as ‘‘confidential’’
[FR Doc. 2016–10687 Filed 5–5–16; 8:45 am] comments, that information will be will not be disclosed except in
BILLING CODE 4164–01–P posted on http://www.regulations.gov. accordance with 21 CFR 10.20 and other
• If you want to submit a comment applicable disclosure law. For more
with confidential information that you information about FDA’s posting of
DEPARTMENT OF HEALTH AND do not wish to be made available to the
HUMAN SERVICES comments to public dockets, see 80 FR
public, submit the comment as a 56469, September 18, 2015, or access
Food and Drug Administration written/paper submission and in the the information at: http://www.fda.gov/
manner detailed (see ‘‘Written/Paper regulatoryinformation/dockets/
21 CFR Part 1150 Submissions’’ and ‘‘Instructions’’). default.htm.
Written/Paper Submissions Docket: For access to the docket to
[Docket No. FDA–2014–D–0917] read background documents or the
Submit written/paper submissions as electronic and written/paper comments
Requirements for the Submission of follows: received, go to http://
Data Needed To Calculate User Fees • Mail/Hand delivery/Courier (for www.regulations.gov and insert the
for Domestic Manufacturers and written/paper submissions): Division of docket number, found in brackets in the
Importers of Tobacco Products; Small Dockets Management (HFA–305), Food heading of this document, into the
Entity Compliance Guide; Availability and Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts
AGENCY: Food and Drug Administration, Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Division of Dockets
HHS. • For written/paper comments Management, 5630 Fishers Lane, Rm.
ACTION: Notification of availability. submitted to the Division of Dockets 1061, Rockville, MD 20852.
Management, FDA will post your Submit written requests for single
SUMMARY: The Food and Drug comment, as well as any attachments, copies of this guidance to the Center for
Administration (FDA) is announcing the except for information submitted, Tobacco Products, Food and Drug
availability of a revised guidance for marked and identified, as confidential, Administration, Document Control
ehiers on DSK5VPTVN1PROD with PROPOSALS
industry entitled ‘‘Requirements for the if submitted as detailed in Center, Bldg. 71, Rm. G335, 10903 New
Submission of Data Needed to Calculate ‘‘Instructions.’’ Hampshire Ave., Silver Spring, MD
User Fees for Domestic Manufacturers Instructions: All submissions received 20993–0002. Send one self-addressed
and Importers of Tobacco Products; must include the Docket No. FDA– adhesive label to assist that office in
Small Entity Compliance Guide’’ for the 2014–D–0917 for ‘‘Small Entity processing your request or include a fax
final user fees rule published July 10, Compliance Guide: Requirements for number to which the guidance
2014, and for the new user fees the Submission of Data Needed To document may be sent. See the
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![28784 Federal Register / Vol. 81, No. 90 / Tuesday, May 10, 2016 / Proposed Rules
SUPPLEMENTARY INFORMATION section for guidance represents the current thinking Washington, DC 20044. Submissions
information on electronic access to the of FDA on this topic. It does not may be hand delivered between the
guidance. establish any rights for any person and hours of 8 a.m. and 4 p.m. to
FOR FURTHER INFORMATION CONTACT: Paul is not binding on FDA or the public CC:PA:LPD:PR (REG–127199–15),
Hart, Center for Tobacco Products, Food unless specific regulatory or statutory Courier’s Desk, Internal Revenue
and Drug Administration, Bldg. 71, Rm. requirements are cited. You can use an Service, 1111 Constitution Avenue NW.,
G335, 10903 New Hampshire Ave., alternative approach if it satisfies the Washington, DC., or sent electronically,
Silver Spring, MD 20993, 1–877–287– requirements of the applicable statutes via the Federal eRulemaking Portal at
1373, email: AskCTP@fda.hhs.gov. and regulations. http://www.regulations.gov (IRS REG–
SUPPLEMENTARY INFORMATION:
127199–15).
III. Electronic Access
FOR FURTHER INFORMATION CONTACT:
I. Background Persons with access to the Internet Concerning the proposed regulations,
FDA is announcing the availability of may obtain an electronic version of the Ronald M. Gootzeit, (202) 317–6937;
a revised guidance for industry entitled guidance at either http:// concerning submissions of comments
‘‘Requirements for the Submission of www.regulations.gov or http://www. and/or requests for a hearing, Regina
Data Needed to Calculate User Fees for fda.gov/TobaccoProducts/Labeling/ Johnson, (202) 317–6901 (not toll-free
Domestic Manufacturers and Importers RulesRegulationsGuidance/default.htm. numbers).
of Tobacco Products; Small Entity Dated: May 3, 2016. SUPPLEMENTARY INFORMATION:
Compliance Guide’’ for the final user fee Leslie Kux,
rules published July 10, 2014 (79 FR Associate Commissioner for Policy. Paperwork Reduction Act
39302). Also, published elsewhere in [FR Doc. 2016–10689 Filed 5–5–16; 8:45 am] The collection of information
this edition of the Federal Register, BILLING CODE 4164–01–P contained in this notice of proposed
FDA issued a final rule to amend 21 rulemaking has been previously
CFR part 1150 (part 1150) to require reviewed and approved by the Office of
domestic manufacturers and importers DEPARTMENT OF THE TREASURY Management and Budget in accordance
of cigars and pipe tobacco to submit to with the Paperwork Reduction Act of
FDA information needed to calculate Internal Revenue Service 1995 (44 U.S.C. 3507(d)) under control
the amount of user fees assessed under number 1545–1191. The estimated
the Federal Food, Drug, and Cosmetic 26 CFR Parts 1 and 301 average annual recordkeeping burden
Act (FD&C Act). FDA issued this user per recordkeeper is 10 hours. The
fee final rule together with the final [REG–127199–15]
estimated reporting burden is being
rule, ‘‘Deeming Tobacco Products To Be RIN 1545–BM94 reported under Form 5472 (OMB #
Subject to the Federal Food, Drug, and 1545–0123).
Cosmetic Act, as Amended by the Treatment of Certain Domestic Entities The collection of information in this
Family Smoking Prevention and Disregarded as Separate From Their proposed regulation is in sections
Tobacco Control Act; Restrictions on the Owners as Corporations for Purposes 1.6038A–1 through 1.6038A–3 and
Sale and Distribution of Tobacco of Section 6038A 1.6038A–5. This information is required
Products and Required Warning in order to provide the IRS with
Statements for Tobacco Products’’ AGENCY: Internal Revenue Service (IRS),
improved access to information that it
(Deeming rule), which deems all Treasury.
needs to satisfy its obligations under
products that meet the statutory ACTION: Notice of proposed rulemaking. U.S. tax treaties, tax information
definition of ‘‘tobacco product,’’ except exchange agreements, and similar
SUMMARY: This document contains
accessories of the newly deemed international agreements, as well as to
proposed regulations that would treat a
tobacco products, to be subject to the strengthen the enforcement of U.S. tax
domestic disregarded entity wholly
FD&C Act. The Deeming rule, among laws. The likely respondents are
owned by a foreign person as a domestic
other things, subjects domestic foreign-owned domestic entities that are
corporation separate from its owner for
manufacturers and importers of cigars disregarded as separate from their
the limited purposes of the reporting,
and pipe tobacco to the FD&C Act’s user owners.
record maintenance and associated
fee requirements. Consistent with the An agency may not conduct or
compliance requirements that apply to
Deeming rule and the requirements of sponsor, and a person is not required to
25 percent foreign-owned domestic
the FD&C Act, this user fee final rule respond to, a collection of information
corporations under section 6038A of the
requires the submission of the unless it displays a valid control
Internal Revenue Code. These changes
information needed to calculate user fee number assigned by the Office of
are intended to provide the IRS with
assessments for each manufacturer and Management and Budget.
improved access to information that it
importer of cigars and pipe tobacco to Books or records relating to a
needs to satisfy its obligations under
FDA. In compliance with section 212 of collection of information must be
U.S. tax treaties, tax information
the Small Business Regulatory retained as long as their contents may
exchange agreements and similar
Enforcement Fairness Act (Pub. L. 104– become material in the administration
international agreements, as well as to
121), FDA is making available this of any internal revenue law. Generally,
strengthen the enforcement of U.S. tax
revised SECG stating in plain language tax returns and tax return information
laws.
ehiers on DSK5VPTVN1PROD with PROPOSALS
the legal requirements of the user fee are confidential, as required by 26
final regulations set forth in part 1150. DATES: Written or electronic comments U.S.C. 6103.
and requests for a public hearing must
II. Significance of Guidance be received by August 8, 2016. Background
FDA is issuing this revised SECG as ADDRESSES: Send submissions to: Sections 301.7701–1 through
a level 2 guidance, consistent with CC:PA:LPD:PR (REG–127199–15), Room 301.7701–3 (‘‘the entity classification
FDA’s good guidance practices 5203, Internal Revenue Service, P.O. regulations’’) classify a business entity
regulation (21 CFR 10.115). The Box 7604, Ben Franklin Station, with two or more members as either a
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Document Created: 2016-05-10 05:18:52
Document Modified: 2016-05-10 05:18:52
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Proposed Rules | |
| Action | Notification of availability. | |
| Dates | Submit either electronic or written comments on Agency guidances at any time. | |
| Contact | Paul Hart, Center for Tobacco Products, Food and Drug Administration, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993, 1-877-287-1373, email: [email protected] | |
| FR Citation | 81 FR 28783 |
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