Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions; Second Edition; Guidance for Industry; Availability, 53810-53811 [2015-22494]

Download as PDF 53810 Federal Register / Vol. 80, No. 173 / Tuesday, September 8, 2015 / Notices TABLE 5—ESTIMATED ANNUAL REPORTING BURDEN FOR ANIMAL DRUGS 1 Number of respondents 21 CFR section Number of responses per respondent Total annual responses Average burden per response Total hours 25.15(a) and (d) ................................................................... 25.40(a) and (c) ................................................................... 70 10 10 1 700 10 3 2,160 2,100 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 Tobacco Products Under sections 905, 910, and 911 of the Federal Food, Drugs, and Cosmetic Act (21 U.S.C. 387, 387j, and 387k), product applications and supplements (PMTAs), SEs, Exemption from SEs, and modified risk tobacco products must contain a claim for categorical exclusion or an EA. In 2015, FDA estimated it will receive approximately 5 premarket review of new tobacco PMTAs from 5 respondents, 509 reports intended to demonstrate the substantial equivalence of a new tobacco product (SEs) from 509 respondents, 15 exemption from substantial equivalence requirements applications (SE Exemptions) from 15 respondents, and 3 modified risk tobacco product applications (MRTPAs) from 3 respondents. FDA is not accepting claims for categorical exclusions at this time, and estimates that there will be 532 EAs from 532 respondents as required under §§ 25.40(a) and (c). Therefore, over the next 3 years, FDA estimates that approximately 532 respondents will submit an average of 1 application for environmental assessment. Part of the information in the EA will be developed while writing other parts of a PMTA, SE, Exemption from SE, or MRTPA. Based on FDA’s experience, previous information provided by potential sponsors and knowledge that part of the EA information has already been produced in one of the tobacco product applications, FDA estimates that it takes approximately 80 hours to prepare an EA. TABLE 6—ESTIMATED ANNUAL REPORTING BURDEN FOR TOBACCO PRODUCTS 1 21 CFR section Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours 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. Leslie Kux, Associate Commissioner for Policy. 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. [FR Doc. 2015–22507 Filed 9–4–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Submit either electronic or written comments on Agency guidances at any time. DATES: [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. asabaliauskas on DSK5VPTVN1PROD with NOTICES ACTION: Notice. 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 SUMMARY: VerDate Sep<11>2014 17:18 Sep 04, 2015 Jkt 235001 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. ADDRESSES: 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, PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 CTPRegulations@fda.hhs.gov, or annette.marthaler@fda.hhs.gov. 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 E:\FR\FM\08SEN1.SGM 08SEN1 Federal Register / Vol. 80, No. 173 / Tuesday, September 8, 2015 / Notices 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 asabaliauskas on DSK5VPTVN1PROD with NOTICES 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. 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:// VerDate Sep<11>2014 17:18 Sep 04, 2015 Jkt 235001 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 A. General Information About Submitting Comments B. Public Availability of Comments 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. 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/ GuidanceComplianceRegulatory Information/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 PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 53811 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request Health Resources and Services Administration, HHS. ACTION: Notice. AGENCY: In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR. DATES: Comments on this Information Collection Request must be received no later than November 9, 2015. ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA Information Collection Clearance Officer, Room 10C–03, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call the HRSA Information Collection Clearance Officer at (301) 443–1984. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the information request collection title for reference. Information Collection Request Title: The Maternal, Infant, and Early Childhood Home Visiting Program Performance Measurement Information System. OMB No. 0906–xxxx—New Abstract: The Maternal, Infant, and Early Childhood Home Visiting Program (MIECHV), administered by HRSA in partnership with the Administration for Children and Families (ACF), supports voluntary, evidence-based home visiting services during pregnancy and to parents with young children up to kindergarten entry. States and Tribal entities are eligible to receive funding from the MIECHV Program and have the flexibility to tailor the program to serve the specific needs of their communities. SUMMARY: E:\FR\FM\08SEN1.SGM 08SEN1

Agencies

[Federal Register Volume 80, Number 173 (Tuesday, September 8, 2015)]
[Notices]
[Pages 53810-53811]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-22494]


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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, CTPRegulations@fda.hhs.gov, or 
annette.marthaler@fda.hhs.gov.

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