80 FR 53810 - Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions; Second Edition; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 173 (September 8, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 173 (September 8, 2015)
| Page Range | 53810-53811 | |
| FR Document | 2015-22494 |
[Federal Register Volume 80, Number 173 (Tuesday, September 8, 2015)] [Notices] [Pages 53810-53811] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-22494] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0147] Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions; Second Edition; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing a second edition of the guidance for industry entitled ``Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions''. FDA is issuing the second edition to provide further information on demonstrating substantial equivalence (SE) of a new tobacco product, including demonstrating SE when the new tobacco product has: A modified label that renders it distinct from, but has identical characteristics to, a valid predicate product; or a change in product quantity from, but where the per weight composition is identical to, a valid predicate product. DATES: Submit either electronic or written comments on Agency guidances at any time. ADDRESSES: All communications in response to this notice should be identified with Docket No. FDA-2011-D-0147. Submit electronic comments on the guidance to http://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: Annette Marthaler, Center for Tobacco Products, Food and Drug Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002; 1-877-287-1373, [email protected], or [email protected]. SUPPLEMENTARY INFORMATION: I. Background We are announcing the availability of the second edition of the guidance for industry entitled ``Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions'' (second edition SE FAQ guidance). We are issuing this guidance consistent with our good guidance practices regulation (21 CFR 10.115). In September 2011, FDA issued draft guidance responding to frequently asked questions covering a range of topics on demonstrating the SE of a new tobacco product (September 9, 2011, 76 FR 55927). In March 2015, FDA issued a final guidance on many of the topics included in the September 2011 draft ((March 5, 2015, 80 FR 12011) (March 2015 FAQ guidance)). In May 2015, FDA announced that an interim enforcement policy would be in effect while it considered comments submitted on the March 2015 FAQ guidance. This interim enforcement policy will continue to be in effect for 30 days from the date of issuance of the [[Page 53811]] second edition SE FAQ guidance. Based on the comments received on the September 2011 draft guidance and the March 2015 final guidance, we are now issuing the second edition FAQ final guidance. The second edition FAQ guidance describes FDA's current thinking on whether and when a change to a tobacco product's label, product quantity in the package, additives, or specifications renders that product a ``new tobacco product'' subject to premarket review. It explains that a manufacturer may submit streamlined SE reports for certain modifications to labels and changes to product quantity. The guidance also explains FDA's plans and processes for review of the streamlined SE reports. Finally, this guidance responds to several questions that have been raised about the SE process more generally. 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. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 This guidance refers to previously approved information collections. These collections of information 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 collections of information in sections 905(j) and 910 of the FD&C Act (21 U.S.C. 387e(j) and 387j, respectively), as amended by the Tobacco Control Act (Pub. L. 111-31), have been approved under OMB control number 0910-0673; the collections of information in 21 CFR part 25 have been approved under OMB control number 0910-0322. III. Comments A. General Information About Submitting Comments Interested persons may submit either electronic comments regarding this document to http://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 http://www.regulations.gov. As a matter of Agency practice, FDA generally does not post comments submitted by individuals in their individual capacity on http://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 http://www.regulations.gov. For this document, however, FDA will not be following this general practice. Instead, FDA will post on http://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 http://www.regulations.gov if you include that information in the body of your comments. For electronic comments submitted to http://www.regulations.gov, FDA will post the body of your comment on http://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 http://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 guidance at either http://www.regulations.gov or http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm. Dated: August 27, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-22494 Filed 9-4-15; 8:45 am] BILLING CODE 4164-01-P
![53810 Federal Register / Vol. 80, No. 173 / Tuesday, September 8, 2015 / Notices
TABLE 5—ESTIMATED ANNUAL REPORTING BURDEN FOR ANIMAL DRUGS 1
Number of Average
Number of Total annual
21 CFR section responses per burden per Total hours
respondents responses
respondent response
25.15(a) and (d) ................................................................... 70 10 700 3 2,100
25.40(a) and (c) ................................................................... 10 1 10 2,160 21,600
Total .............................................................................. ........................ ........................ ........................ ........................ 23,700
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Estimated Annual Reporting Burden for demonstrate the substantial equivalence approximately 532 respondents will
Tobacco Products of a new tobacco product (SEs) from 509 submit an average of 1 application for
respondents, 15 exemption from environmental assessment. Part of the
Under sections 905, 910, and 911 of substantial equivalence requirements information in the EA will be developed
the Federal Food, Drugs, and Cosmetic applications (SE Exemptions) from 15 while writing other parts of a PMTA,
Act (21 U.S.C. 387, 387j, and 387k), respondents, and 3 modified risk SE, Exemption from SE, or MRTPA.
product applications and supplements tobacco product applications (MRTPAs) Based on FDA’s experience, previous
(PMTAs), SEs, Exemption from SEs, and from 3 respondents. FDA is not information provided by potential
modified risk tobacco products must accepting claims for categorical sponsors and knowledge that part of the
contain a claim for categorical exclusion exclusions at this time, and estimates EA information has already been
or an EA. In 2015, FDA estimated it will that there will be 532 EAs from 532 produced in one of the tobacco product
receive approximately 5 premarket respondents as required under applications, FDA estimates that it takes
review of new tobacco PMTAs from 5 §§ 25.40(a) and (c). Therefore, over the approximately 80 hours to prepare an
respondents, 509 reports intended to next 3 years, FDA estimates that EA.
TABLE 6—ESTIMATED ANNUAL REPORTING BURDEN FOR TOBACCO PRODUCTS 1
Number of Average
Number of Total annual
21 CFR section responses per burden per Total hours
respondents responses
respondent response
25.40(a) and (c) ................................................................... 532 1 532 80 42,560
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: August 31, 2015. substantial equivalence (SE) of a new CTPRegulations@fda.hhs.gov, or
Leslie Kux, tobacco product, including annette.marthaler@fda.hhs.gov.
Associate Commissioner for Policy. demonstrating SE when the new tobacco SUPPLEMENTARY INFORMATION:
[FR Doc. 2015–22507 Filed 9–4–15; 8:45 am] product has: A modified label that
renders it distinct from, but has I. Background
BILLING CODE 4164–01–P
identical characteristics to, a valid We are announcing the availability of
predicate product; or a change in the second edition of the guidance for
DEPARTMENT OF HEALTH AND product quantity from, but where the industry entitled ‘‘Demonstrating the
HUMAN SERVICES per weight composition is identical to, Substantial Equivalence of a New
a valid predicate product. Tobacco Product: Responses to
Food and Drug Administration Frequently Asked Questions’’ (second
DATES: Submit either electronic or edition SE FAQ guidance). We are
[Docket No. FDA–2011–D–0147] written comments on Agency guidances issuing this guidance consistent with
at any time. our good guidance practices regulation
Demonstrating the Substantial
Equivalence of a New Tobacco ADDRESSES: All communications in (21 CFR 10.115).
response to this notice should be In September 2011, FDA issued draft
Product: Responses to Frequently
identified with Docket No. FDA–2011– guidance responding to frequently asked
Asked Questions; Second Edition;
D–0147. Submit electronic comments on questions covering a range of topics on
Guidance for Industry; Availability
the guidance to http:// demonstrating the SE of a new tobacco
AGENCY: Food and Drug Administration, www.regulations.gov. Submit written product (September 9, 2011, 76 FR
HHS. comments to the Division of Dockets 55927). In March 2015, FDA issued a
ACTION: Notice. Management (HFA–305), Food and Drug final guidance on many of the topics
Administration, 5630 Fishers Lane, Rm. included in the September 2011 draft
SUMMARY: The Food and Drug ((March 5, 2015, 80 FR 12011) (March
asabaliauskas on DSK5VPTVN1PROD with NOTICES
1061, Rockville, MD 20852.
Administration (FDA) is announcing a 2015 FAQ guidance)). In May 2015,
second edition of the guidance for FOR FURTHER INFORMATION CONTACT: FDA announced that an interim
industry entitled ‘‘Demonstrating the Annette Marthaler, Center for Tobacco enforcement policy would be in effect
Substantial Equivalence of a New Products, Food and Drug while it considered comments
Tobacco Product: Responses to Administration, Document Control submitted on the March 2015 FAQ
Frequently Asked Questions’’. FDA is Center, Bldg. 71, Rm. G335, 10903 New guidance. This interim enforcement
issuing the second edition to provide Hampshire Ave., Silver Spring, MD policy will continue to be in effect for
further information on demonstrating 20993–0002; 1–877–287–1373, 30 days from the date of issuance of the
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![Federal Register / Vol. 80, No. 173 / Tuesday, September 8, 2015 / Notices 53811
second edition SE FAQ guidance. Based www.regulations.gov. As a matter of DEPARTMENT OF HEALTH AND
on the comments received on the Agency practice, FDA generally does HUMAN SERVICES
September 2011 draft guidance and the not post comments submitted by
March 2015 final guidance, we are now individuals in their individual capacity Health Resources and Services
issuing the second edition FAQ final on http://www.regulations.gov. This is Administration
guidance. determined by information indicating
The second edition FAQ guidance Agency Information Collection
that the submission is written by an Activities: Proposed Collection: Public
describes FDA’s current thinking on individual, for example, the comment is
whether and when a change to a tobacco Comment Request
identified with the category ‘‘Individual
product’s label, product quantity in the Consumer’’ under the field titled AGENCY: Health Resources and Services
package, additives, or specifications ‘‘Category (Required),’’ on the ‘‘Your Administration, HHS.
renders that product a ‘‘new tobacco Information’’ page on http:// ACTION: Notice.
product’’ subject to premarket review. It
www.regulations.gov. For this
explains that a manufacturer may SUMMARY: In compliance with the
document, however, FDA will not be requirement for opportunity for public
submit streamlined SE reports for
certain modifications to labels and following this general practice. Instead, comment on proposed data collection
changes to product quantity. The FDA will post on http:// projects (Section 3506(c)(2)(A) of the
guidance also explains FDA’s plans and www.regulations.gov comments to this Paperwork Reduction Act of 1995), the
processes for review of the streamlined docket that have been submitted by Health Resources and Services
SE reports. Finally, this guidance individuals in their individual capacity. Administration (HRSA) announces
responds to several questions that have If you wish to submit any information plans to submit an Information
been raised about the SE process more under a claim of confidentiality, please Collection Request (ICR), described
generally. refer to 21 CFR 10.20. below, to the Office of Management and
The guidance represents the current Budget (OMB). Prior to submitting the
C. Information Identifying the Person
thinking of FDA on this topic. It does ICR to OMB, HRSA seeks comments
Submitting the Comment
not establish any rights for any person from the public regarding the burden
and is not binding on FDA or the public. Please note that your name, contact estimate, below, or any other aspect of
You can use an alternative approach if information, and other information the ICR.
it satisfies the requirements of the identifying you will be posted on http:// DATES: Comments on this Information
applicable statutes and regulations. www.regulations.gov if you include that Collection Request must be received no
II. Paperwork Reduction Act of 1995 information in the body of your later than November 9, 2015.
comments. For electronic comments ADDRESSES: Submit your comments to
This guidance refers to previously paperwork@hrsa.gov or mail the HRSA
submitted to http://
approved information collections. These Information Collection Clearance
collections of information are subject to www.regulations.gov, FDA will post the
body of your comment on http:// Officer, Room 10C–03, Parklawn
review by the Office of Management and Building, 5600 Fishers Lane, Rockville,
Budget (OMB) under the Paperwork www.regulations.gov along with your
state/province and country (if MD 20857.
Reduction Act of 1995 (44 U.S.C. 3501– FOR FURTHER INFORMATION CONTACT: To
3520). The collections of information in provided), the name of your
representative (if any), and the category request more information on the
sections 905(j) and 910 of the FD&C Act proposed project or to obtain a copy of
(21 U.S.C. 387e(j) and 387j, identifying you (e.g., individual,
consumer, academic, industry). For the data collection plans and draft
respectively), as amended by the instruments, email paperwork@hrsa.gov
Tobacco Control Act (Pub. L. 111–31), written submissions submitted to the
or call the HRSA Information Collection
have been approved under OMB control Division of Dockets Management, FDA
Clearance Officer at (301) 443–1984.
number 0910–0673; the collections of will post the body of your comments on
SUPPLEMENTARY INFORMATION: When
information in 21 CFR part 25 have been http://www.regulations.gov, but you can
submitting comments or requesting
approved under OMB control number put your name and/or contact
information, please include the
0910–0322. information on a separate cover sheet information request collection title for
III. Comments and not in the body of your comments. reference.
IV. Electronic Access Information Collection Request Title:
A. General Information About
The Maternal, Infant, and Early
Submitting Comments Persons with access to the Internet Childhood Home Visiting Program
Interested persons may submit either may obtain an electronic version of the Performance Measurement Information
electronic comments regarding this guidance at either http:// System.
document to http://www.regulations.gov www.regulations.gov or http:// OMB No. 0906–xxxx—New
or written comments to the Division of www.fda.gov/TobaccoProducts/ Abstract: The Maternal, Infant, and
Dockets Management (see ADDRESSES). It GuidanceComplianceRegulatory Early Childhood Home Visiting Program
is only necessary to send one set of Information/default.htm. (MIECHV), administered by HRSA in
comments. Identify comments with the partnership with the Administration for
Dated: August 27, 2015. Children and Families (ACF), supports
asabaliauskas on DSK5VPTVN1PROD with NOTICES
docket number found in brackets in the
heading of this document. Leslie Kux, voluntary, evidence-based home visiting
Associate Commissioner for Policy. services during pregnancy and to
B. Public Availability of Comments parents with young children up to
[FR Doc. 2015–22494 Filed 9–4–15; 8:45 am]
Received comments may be seen in BILLING CODE 4164–01–P
kindergarten entry. States and Tribal
the Division of Dockets Management entities are eligible to receive funding
between 9 a.m. and 4 p.m., Monday from the MIECHV Program and have the
through Friday, and will be posted to flexibility to tailor the program to serve
the docket at http:// the specific needs of their communities.
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Document Created: 2018-02-26 10:13:32
Document Modified: 2018-02-26 10:13:32
| 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 | Notices | |
| Action | Notice. | |
| Dates | Submit either electronic or written comments on Agency guidances at any time. | |
| Contact | Annette Marthaler, Center for Tobacco Products, Food and Drug Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002; 1-877-287-1373, [email protected], or [email protected] | |
| FR Citation | 80 FR 53810 |
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