2019-11657. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence ...

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (PRA).

DATES:

Fax written comments on the collection of information by July 5, 2019.

ADDRESSES:

To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: [phone], or emailed to [e-mail]. All comments should be identified with the OMB control number 0910-0673. Also include the FDA docket number found in brackets in the heading of this document.

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:

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

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

OMB Control Number 0910-0673—Extension

On June 22, 2009, the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-31) was signed 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, generally 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 (21 U.S.C. 387j(a)(2)(A)) before the product may be introduced into commercial distribution (section 910 of the FD&C Act).

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) of the FD&C Act (21 U.S.C. 387a(b))). 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”).

The FD&C Act authorizes three premarket pathways for a new tobacco product to legally enter the market. 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 pathway. Under section 905(j)(1)(A)(i) of the FD&C Act (21 U.S.C. 387e(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 of Health and Human Services has previously determined, under 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 as required under section 905(j)(1)(A)(i) of the FD&C Act. FDA's guidance entitled “Demonstrating the Substantial Equivalence of a New Tobacco Product: Responses to Frequently Asked Questions” (December 2016) 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 Substantial Equivalence (SE) Report for certain modifications that should be easier for manufacturers to prepare.

In the Federal Register of September 6, 2018 (83 FR 45251), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received seven comments that were PRA related. Commenters noted that the burden estimates seem low given current experience and rounds of review by FDA, but that FDA could reduce the current burden by increasing transparency in the SE process by issuing a rulemaking related to SE. These comments concerned the burdens related to the SE program and noted that lack of a rule related to the SE pathway has contributed to that burden. In addition, commenters stated that lack of clarity on the content of SE Reports, including the lack of clarity regarding the information that might be needed when a new tobacco product has “same characteristics” or “different characteristics,” contributes to that burden.

We believe that recent activities undertaken by FDA will help address these concerns and support maintaining the current estimates, which are averages of burden across a number of years. Specifically, in October 2018, FDA held a public workshop that provided industry stakeholders with additional information on SE content and process (https://www.fda.gov/​TobaccoProducts/​NewsEvents/​ucm615443.htm). More recently, FDA issued a notice of proposed rulemaking related to the content and format of SE Reports (84 FR 12740, April 2, 2019), which would establish the required content of SE Reports and explain FDA review practices. This proposed rule also provides potential approaches to addressing same characteristics and different characteristics, along with examples, and considerations FDA may evaluate in determining whether difference(s) in characteristics cause the new tobacco product to raise different questions of public health. FDA is seeking comment on that proposed rule.

In addition, we note that several of the commenters are cigar industry stakeholders who indicated that submissions may be higher for cigar products than our current estimates reflect, and we acknowledge that future collections may be further refined to reflect changes in numbers of submissions due to more SE submissions for cigar products related to 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 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 each year.

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

FDA estimates that it will receive 239 Product Quantity Change SE Reports each year 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 each year 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 accounted for.

Therefore, FDA estimates the annual 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: May 30, 2019.

Lowell J. Schiller,

Principal Associate Commissioner for Policy.