2018-19353. Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on “Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products.”

DATES:

Submit either electronic or written comments on the collection of information by November 5, 2018.

ADDRESSES:

You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before November 5, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of November 5, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

Electronic Submissions

Submit electronic comments in the following way:

• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Dockets Management Staff, 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-2011-D-0147 for “Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov. Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/​fdsys/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [e-mail].

SUPPLEMENTARY INFORMATION:

Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Guidance for Industry and Food and Drug Administration Staff on Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products

OMB Control Number 0910-0673—Extension

On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-31) into law. The Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding, among other things, a chapter granting FDA authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health generally and to reduce tobacco use by minors.

The FD&C Act, as amended by the Tobacco Control Act, requires that before a new tobacco product may be introduced or delivered for introduction into interstate commerce, the new tobacco product must undergo premarket review by FDA. FDA must issue an order authorizing the commercial distribution of the new tobacco product or find the product exempt from the requirements of substantial equivalence under section 910(a)(2)(A) of the FD&C Act, before the product may be introduced into commercial distribution (section 910 of the FD&C Act (21 U.S.C. 387j)).

FDA has issued a guidance document containing recommendations for preparing substantial equivalence reports (SE Reports) under section 905(j)(1)(A)(i). A tobacco product manufacturer must show that a new tobacco product is substantially equivalent, within the meaning of section 910, to a tobacco product commercially marketed (other than for test marketing) in the United States as of February 15, 2007, or to a tobacco product that the Secretary has previously determined, pursuant to subsection (a)(3) of section 910, is substantially equivalent and that it is in compliance with the requirements of the FD&C Act. The comparison product chosen by the tobacco product manufacturer is referred to by FDA as the predicate tobacco product.

The guidance document associated with this collection of information contains recommendations on preparing reports intended to demonstrate substantial equivalence to a predicate tobacco product and compliance with the FD&C Act as required under section 905(j)(1)(A)(i). Submission of a section 905(j)(1)(A)(i) report intended to demonstrate substantial equivalence and, in response, an order from the Agency finding that the new tobacco product is substantially equivalent to a predicate tobacco product and in compliance with the requirements of the FD& C Act, is one means for a new tobacco product to legally enter the market. FDA's guidance entitled “Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions” (December 2016). This guidance may be accessed at https://www.fda.gov/​TobaccoProducts/​Labeling/​RulesRegulationsGuidance/​default.htm). In that guidance, FDA recommends that certain modifications might be addressed in a “Product Quantity Change Report,” which is a more streamlined SE Reports for certain modifications that should be easier for manufacturers to prepare.

The Tobacco Control Act also gave FDA the authority to issue a regulation deeming all other products that meet the statutory definition of a tobacco product to be subject to Chapter IX of the FD&C Act (section 901(b) (21 U.S.C. 387a(b)) of the FD&C Act). On May 10, 2016, FDA issued that rule, extending FDA's tobacco product authority to all products that meet the definition of tobacco product in the law (except for accessories of newly regulated tobacco products), including electronic nicotine delivery systems, cigars, hookah, pipe tobacco, nicotine gels, dissolvables that were not already subject to the FD&C Act, and other tobacco products that may be developed in the future (81 FR 28974 at 28976) (“the Deeming final rule”).

FDA estimates the burden of this collection of information as follows:

Table 1—Estimated Annual Reporting Burden ¹

Activity	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours
Full SE 905(j)(1)(A)(i) and 910(a)	683	1	683	300	204,900
Full SE 905(j)(1)(A)(i) and 910(a) Bundled	456	1	456	90	41,040
Product Quantity Change SE Report	239	1	239	87	20,793
Product Quantity Change Bundled SE Report	192	1	192	62	11,904
Total					278,637
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

FDA's estimates are based on experience with SE Reports, initial updated deemed registration and listing data, interactions with the industry, and information related to other regulated products. The estimated number of SE Reports is expected to increase from an annual average of 979 to 1,570.

When groups of full or product quantity change SE Reports have identical content, they may be bundled; when a group of similar reports are bundled, the subsequent bundled reports are expected to take less time to prepare than the initial report.

FDA has based these estimates on information it now has available from interactions with the industry, information related to other regulated products, and FDA expectations regarding the tobacco industry's use of the section 905(j) pathway to market their products. Table 1 describes the annual reporting burden as a result of the implementation of the substantial equivalence requirements of sections 905(j)(1)(A)(i) and 910(a) of the FD&C Act (21 U.S.C. 387j(a)) for an SE application.

FDA estimates that 683 respondents will prepare and submit 683 section 905(j)(1)(A)(i) SE Reports each year. In addition, anyone submitting an SE Report is required to submit an environmental assessment (EA) under 21 CFR 25.40. The burden for environmental reports has been included in the burden per response for each type of SE report. Based on FDA's experience with EAs for currently regulated tobacco products, we expect industry to spend 80 hours to prepare an environmental assessment for a SE Report. Thus, FDA estimates that it will take a manufacturer approximately 300 hours per report to prepare an SE Report and the EA for a new tobacco product, which is a total of 204,900 hours.

In addition, we estimate receiving 456 Full SE Bundled Reports at 90 hours per submission for a total of 41,040 hours.

FDA estimates that it will receive 239 Product Quantity Change SE Reports and that it will take a manufacturer approximately 87 hours to prepare this report for a total of 20,793 hours. This includes time to prepare the environmental assessment, which FDA believes will take less time due to the typically more limited modification(s) included in a Product Quantity Change SE Report. We estimate receiving 192 Product Quantity Change Bundled SE Reports at approximately 62 hours per submission for a total of 11,904 hours, this number excludes the time for the initial SE Report which was previously account for.

Therefore, FDA estimates the burden for submission of SE information will be 278,637 hours. This is an increase of 106,759 hours from the currently approved burden. We attribute this increase to an increase in the number of SE Reports we expect related to Deemed products (e.g., based on the initial registration and listing information).

Dated: August 31, 2018.

Leslie Kux,

Associate Commissioner for Policy.