2019-10287. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tobacco Products, User Fees, Requirements for the Submission of Data Needed To Calculate User Fees for Domestic ...

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA or Agency) 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.

DATES:

Fax written comments on the collection of information by June 17, 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 0910-0749. 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.

Tobacco Products, User Fees, Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products

OMB Control Number 0910-0749—Extension

On June 22, 2009, the Family Smoking Prevention and Tobacco Control Act (the 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) and granted FDA authority to regulate the manufacture, marketing, and distribution of tobacco products to protect public health generally and to reduce tobacco use by minors.

FDA issued a final rule that requires domestic manufacturers and importers of cigars and pipe tobacco to submit information needed to calculate the amount of user fees assessed under the FD&C Act (https://www.govinfo.gov/​content/​pkg/​FR-2016-05-10/​pdf/​2016-10688.pdf). FDA expanded its authority over tobacco products by issuing another 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), deeming 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 (https://www.govinfo.gov/​content/​pkg/​FR-2016-05-10/​pdf/​2016-10685.pdf). The Deeming rule, among other things, subjected 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, the 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.

As noted, FDA issued a final rule that requires domestic tobacco product manufacturers and importers to submit information needed to calculate the amount of user fees assessed under the FD&C Act. The U.S. Department of Agriculture (USDA) had been collecting this information and provided FDA with the data the Agency needed to calculate the amount of user fees assessed to tobacco product manufacturers and importers. USDA ceased collecting this information in fiscal year 2015 (October 2014). USDA's information collection did not require OMB approval, per an exemption by Public Law 108-357, section 642(b)(3). Consistent with the requirements of the FD&C Act, FDA requires the submission of this information to FDA now instead of USDA. FDA took this action to ensure that the Agency continues to have the information needed to calculate, assess, and collect user fees from domestic manufacturers and importers of tobacco products.

Section 919(a) of the FD&C Act (21 U.S.C. 387s(a)) requires FDA to “assess user fees on, and collect such fees from, each manufacturer and importer of tobacco products” subject to the tobacco product provisions of the FD&C Act (chapter IX of the FD&C Act). The total amount of user fees to be collected for each fiscal year is specified in section 919(b)(1) of the FD&C Act, and under section 919(a) FDA is to assess and collect a proportionate amount each quarter of the fiscal year. The FD&C Act provides for the total assessment to be allocated among the classes of tobacco products. The class allocation is based on each tobacco product class' volume of tobacco product removed into commerce. Within each class of tobacco products, an individual domestic manufacturer or importer is assessed a user fee based on its share of the market for that tobacco product class.

In the Federal Register of September 11, 2018 (83 FR 45937), FDA published a 60-day notice requesting public comment on the proposed collection of information. One comment was received that was not PRA related.

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

Table 1—Estimated Annual Reporting Burden ¹

21 CFR section	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours
1150.5(a), (b)(1) and (2), and Form FDA 3852; General identifying information provided by manufacturers and importers of FDA regulated tobacco products and identification and removal information (monthly)	658	12	7,896	3	23,688
1150.5(b)(3); Certified copies (monthly)	658	12	7,896	1	7,896
1150.13; Submission of user fee information (identifying information, fee amount, etc.) (quarterly)	329	4	1,316	1	1,316
1150.15(a); Submission of user fee dispute (annually)	5	1	5	10	50
1150.15(d); Submission of request for further review of dispute of user fee (annually)	3	1	3	10	30
Total					32,980
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

FDA estimates that 658 entities will submit tobacco product user fees. The entity count was derived from aggregate data provided by the Alcohol and Tobacco Tax and Trade Bureau (TTB), and reflects that in 2017 there were 192 total permitted manufacturers and 466 permitted importers over all tobacco product types for which TTB collects excise taxes (including cigarettes, cigars, snuff, chewing tobacco, pipe tobacco, and roll-your-own tobacco, excluding electronic nicotine delivery systems).

The estimate of 658 respondents to provide the information requested from § 1150.5(a), (b)(1) and (2) (21 CFR 1150.5(a), (b)(1) and (2)), and Form FDA 3852 reflects both reports of no removal of tobacco products into domestic commerce and reports of removal of tobacco product into domestic commerce. FDA estimates it will take 3 hours for each of these submission types for a total of 23,688 hours. Under § 1150.5(b)(3), these respondents are also expected to provide monthly certified copies of the returns and forms that relate to the removal of tobacco products into domestic commerce and the payment of Federal excise taxes imposed under chapter 52 of the Internal Revenue Code of 1986 to FDA. We estimate that each monthly report will take 1 hour for a total of 7,896 hours. The estimate of 329 respondents to submit payment of user fee information under § 1150.13 reflects an average of half the number of domestic manufacturers and importers who may be subject to fees each fiscal quarter. FDA estimates the quarterly submission will take approximately 1 hour for a total of 1,316 hours.

FDA estimates that five of those respondents assessed user fees will dispute the amounts under § 1150.15(a), for a total amount of 50 hours. FDA also estimates that three respondents who dispute their user fees will ask for further review by FDA under § 1150.15(d), for a total amount of 30 hours. FDA has only received one dispute submission since fiscal year 2015. Based on this data, the Agency does not believe we will receive more than five disputes and three requests for further reviews in the next 3 years.

FDA estimates the total annual burden for this collection of information is 32,980 hours. The estimated burden for the information collection reflects an overall increase of 16,058 hours. We attribute this adjustment to an increase in the number of entities submitting tobacco user fee information to FDA.

Dated: May 14, 2019.

Lowell J. Schiller,

Principal Associate Commissioner for Policy.