2022-15727. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tobacco Health Document Submission

AGENCY:

Food and Drug Administration, Health and Human Services (HHS).

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA, Agency, or we) 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:

Submit written comments (including recommendations) on the collection of information by August 22, 2022.

ADDRESSES:

To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https://www.reginfo.gov/​public/​do/​PRAMain. Find this particular information collection by selecting “Currently under Review—Open for Public Comments” or by using the search function. The OMB control number for this information collection is 0910-0654. Also include the FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Rachel Showalter, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399, [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 Health Document Submission

OMB Control Number 0910-0654—Revision

Section 904(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 387d(a)(4)) requires each tobacco product manufacturer or importer, or agent thereof, to submit all documents developed after June 22, 2009, “that relate to health, toxicological, behavioral, or physiologic effects of current or future tobacco products, their constituents (including smoke constituents), ingredients, components, and additives” (herein referred to as “tobacco health documents” or “health documents”).

The guidance document entitled “Health Document Submission Requirements for Tobacco Products (Revised)” (2017) ( https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents/​tobacco-health-document-submission ) requests tobacco health document submissions from manufacturers and importers of tobacco products based on statutory requirements and compliance dates.^[1] As indicated in the guidance, all manufacturers and importers of tobacco products are now subject to the FD&C Act and are required to comply with section 904(a)(4) of the FD&C Act, which requires immediate and ongoing submission of health documents developed after June 22, 2009 (the date of enactment of the Tobacco Control Act). However, FDA generally does not intend to enforce the requirement at this time with respect to all such health documents, so long as a specified set of documents, those developed between June 23, 2009, and December 31, 2009, are provided at least 90 days prior to the delivery for introduction of tobacco products into interstate commerce. Thereafter, manufacturers should preserve all health documents, including those that relate to products for further manufacturing and those developed after December 31, 2009, for future submission to FDA. All Agency guidance documents are issued in accordance with our good guidance practice regulations in 21 CFR 10.115, which provide for public comment at any time.

FDA is planning revisions to the guidance to reflect that the deemed tobacco product compliance period has passed. Additional revisions include clarifying and editorial changes to promote a better understanding of FDA's interpretation of the “health, toxicological, behavioral, or physiologic” phrase, examples of health, toxicological, behavioral, or physiologic effects documents, and minor updates to the metadata list.

FDA has been collecting the information submitted pursuant to section 904(a)(4) of the FD&C Act through a facilitative electronic form and through a paper form (Form FDA 3743) for those individuals who choose not to use the electronic method. On both forms, FDA is requesting the following information from firms that have not already reported or still have documents to report:

• Submitter identification
• Submitter type, company name, address, country, company headquarters Dun and Bradstreet D-U-N-S number, and FDA assigned Facility Establishment Identifier (FEI) number
• Submitter point of contact
• Contact name, title, position title, email, telephone, and Fax
• Submission format and contents (as applicable)
• Electronic documents: media type, media quantity, size of submission, quantity of documents, file type, and file software
• Paper documents: quantity of documents, quantity of volumes, and quantity of boxes
• Whether or not a submission is being provided
• Confirmation statement
• Identification and signature of submitter including name, company name, address, position title, email, telephone, and Fax
• Document categorization (as applicable): relationship of the document or set of documents to the following:

○ Health, behavioral, toxicological, or physiological effects

○ Uniquely identified current or future tobacco product(s)

○ Category of current or future tobacco product(s)

○ Specific ingredient(s), constituent(s), component(s), or additive(s)

○ Class of ingredient(s), constituent(s), component(s), or additive(s)

• Document readability and accessibility: keywords; glossary or explanation of any abbreviations, jargon, or internal ( e.g., code) names; special instructions for loading or compiling submission.

• Document metadata: date document was created, document author(s), document recipient(s), document custodian, document title or identification number, beginning and ending Bates numbers, Bates number ranges for documents attached to a submitted email, document type, and whether the document is present in the University of California San Francisco's Truth Tobacco Documents database.

You may access the electronic form and paper form on our website, at https://www.fda.gov/​tobacco-products/​manufacturing/​submit-documents-ctp-portal and https://www.fda.gov/​media/​78652/​download, respectively. In addition to the electronic and paper forms, FDA issued the guidance on this collection to assist persons making tobacco health document submissions. For further assistance, FDA is providing a technical guide, embedded hints, and a web tutorial on the electronic portal.

FDA issued a final rule to deem products meeting the statutory definition of “tobacco product” to be subject to the FD&C Act on May 10, 2016 (81 FR 28973), which became effective on August 8, 2016. The FD&C Act provides FDA authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco (RYO), smokeless tobacco, and any other tobacco products that the Agency by regulation deems to be subject to the law. This final rule extended the Agency's “tobacco product” authorities to all other categories of products that meet the statutory definition of “tobacco product” in the FD&C Act, except accessories of such deemed tobacco products.

For tobacco products subject to the deeming rule, FDA understands “current or future tobacco products” to refer to products commercially distributed on or after August 8, 2016, or products in any stage of research or development at any time after August 8, 2016, including experimental products and developmental products intended for introduction into the market for consumer use. For cigarettes, cigarette tobacco, RYO, and smokeless tobacco, FDA understands “current or future tobacco products” to refer to products commercially distributed on or after June 23, 2009, or products in any stage of research or development at any time after June 23, 2009, including experimental products and developmental products intended for introduction into the market for consumer use.

In the guidance on this collection, FDA indicated our intent to enforce the requirement at this time with respect to all such health documents relating to the deemed tobacco products, so long as a specified set of documents, those developed between June 23, 2009, and December 31, 2009, were submitted by February 8, 2017, or in the case of small-scale deemed tobacco product manufacturers (small-scale manufacturers), by November 8, 2017 (81 FR 28973 at 29008 and 29009). Additionally, FDA extended the compliance deadlines by an additional 6 months for small-scale manufacturers in the areas impacted by natural disasters to May 8, 2018. Thereafter, FDA's compliance plan requested deemed manufacturers provide tobacco health document submissions from the specified period, at least 90 days prior to the delivery for introduction into interstate commerce of tobacco products to which the health documents relate. Manufacturers or importers of cigarettes, cigarette tobacco, RYO, or smokeless tobacco products must provide all health documents developed between June 23, 2009, and December 31, 2009, at least 90 days prior to the delivery for introduction of tobacco products into interstate commerce.

After publication of the 60-day notice however, on March 15, 2022, President Biden signed H.R. 2471—the Consolidated Appropriations Act, 2022. As a result, the FD&C Act now includes specific language that makes clear that FDA has the authority to regulate tobacco products containing nicotine from any source, which includes synthetic. On April 14, 2022, firms engaged in the manufacture, preparation, compounding, or processing of tobacco products containing non-tobacco nicotine products (NTN) must therefore provide health documents.

In the Federal Register of February 25, 2022 (87 FR 10800), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

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
Tobacco Health Document Submissions and Form FDA 3743	10	3.2	32	50	1,600
Tobacco Health Document Submissions and Form 3743 for Non-Tobacco Nicotine Products (NTN)	100	1	100	2	200
Total					1,800

The number of documents received each year since the original collection period has fallen to less than 5 percent of what was received in the original collection period. FDA expects this is because documents created within the specified period should have already been submitted. The Agency bases this estimate on the total number of tobacco firms it is aware of and its experience with document production and the number of additional documents that have been reported each year since the original estimate of the reporting burden.

FDA estimates that a tobacco health document submission as required by section 904(a)(4) of the FD&C Act, will take approximately 50 hours per submission based on FDA experience. To derive the number of respondents for this provision, FDA assumes that very few manufacturers or importers, or agents thereof, would have health documents to submit. We anticipate documents will be submitted on an annual basis for a total of 10 respondents. FDA estimates the annual reporting burden for these respondents to be 1,600 hours.

As mentioned previously in this document, with the new authority provided to FDA, firms engaged in the manufacture, preparation, compounding, or processing of tobacco products containing NTN must provide health documents. Although these firms are unlikely to have health documents created within the specified period, we are estimating for this extension that we will receive 100 new NTN respondents who will be required to provide a declaration to such effect via Form 3743, which is expected to take 2 hours, for a total 200 burden hours.

Based on a review of the information collection of our current OMB approval, we have increased the burden by 200 hours.

Dated: July 18, 2022.

Lauren K. Roth,

Associate Commissioner for Policy.

Footnotes

1.  FDA announced the availability of a guidance on this collection in the Federal Register on April 20, 2010 (75 FR 20606) (revised December 5, 2016 (81 FR 87565)).