Document ID: FDA-2019-N-2854-1146
Agency: fda
Document Type: Proposed Rule
Title: Premarket Tobacco Product Applications and Recordkeeping Requirements; Reopening of the Comment Period
Posted Date: 2020-03-10T04:00Z

[Federal Register Volume 85, Number 47 (Tuesday, March 10, 2020)]
[Proposed Rules]
[Pages 13840-13841]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04828]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1100, 1107, and 1114

[Docket No. FDA-2019-N-2854]
RIN 0910-AH44

Premarket Tobacco Product Applications and Recordkeeping 
Requirements; Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; reopening of the comment period.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
reopening the comment period only for the agency information collection 
activity associated with proposed rulemaking entitled ``Premarket 
Tobacco Product Applications and Recordkeeping Requirements,'' which 
appeared in the Federal Register of September 25, 2019. FDA is not 
reopening the comment period associated with any other aspects of the 
proposed rulemaking. The Agency is taking this action to seek comment 
on an additional proposed form to collect information that would be 
required under certain provisions of the proposed rule. This proposed 
form would allow for easier identification of each new tobacco product 
contained in a grouped submission of premarket tobacco product 
applications (PMTAs). FDA is reopening the comment period only on the 
proposed agency information collection activity to allow interested 
persons additional time to submit comments on this form.

DATES: FDA is reopening the comment period on the agency information 
collection activity contained in the proposed rule published in the 
Federal Register of September 25, 2019 (84 FR 50566). Submit either 
electronic or written comments by April 9, 2020.

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: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0879 and 
title ``Premarket Tobacco Product Applications and Recordkeeping

[[Page 13841]]

Requirements.'' Also include the FDA docket number found in brackets in 
the heading of this document.
    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: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of September 25, 
2019 (84 FR 50566), FDA published a proposed rule that included an 
agency information collection assessment with a 60-day comment period 
to request comments on proposed requirements related to PMTA reporting 
and recordkeeping. In the Federal Register of November 26, 2019 (84 FR 
65044), FDA published a document reopening the comment period on the 
proposed rule for an addition 20 days in response to multiple requests 
from commenters and the comment period closed on December 16, 2019.
    FDA is reopening the comment period for the agency information 
collection activity associated with the proposed rulemaking for a 
period of 30 days, until April 9, 2020, to allow comment on an 
additional proposed form. The Agency believes that a 30-day extension 
allows adequate time for interested persons to submit comments without 
significantly delaying rulemaking.
    FDA has included an additional proposed form (Form FDA 4057b) in 
the docket that will assist industry and FDA in identifying the 
products that are the subject of a submission where an applicant groups 
multiple PMTAs into a single submission (referred to as a bundled 
submission or a grouped submission). FDA has previously stated that one 
approach to submitting PMTAs could be to group applications for 
products that are both from the same manufacturer or domestic importer 
and in the same product category and subcategory into a single 
submission. FDA discusses bundled submissions in the proposed rule (84 
FR 50566 at 50578) and notes that FDA intends to consider information 
on each tobacco product as a separate, individual PMTA. The form would 
assist applicants in providing the unique identifying information for 
each product in a grouped submission of PMTAs that would be required by 
table 1 to 21 CFR 1114.7(c)(3)(iii) of the proposed rule (84 FR 50566 
at 50637). By having the identifying information for products contained 
in a submission be more clearly organized, FDA will be able to more 
efficiently process and review the applications contained in a grouped 
submission.
    FDA is revising table 22 from the Paperwork Reduction Act section 
contained in the proposed rule (84 FR 50566 at 50627) to add the 
associated burden for the additional proposed form. We estimate that 24 
respondents will complete Form FDA 4057b for a total of 96 hours. Based 
on the Form FDA 4057 for use when submitting PMTA single and bundled 
submissions, FDA estimated that 24 respondents will submit PMTA bundles 
per year. Form FDA 4057b would be created once for each submission 
containing more than one PMTA. We assume the submitter could include 
from 2 to 2,000 products in each Form FDA 4057b. Entering data for up 
to 2,000 rows can take approximately 4 hours on average per Form FDA 
4057b for manual data entry. If the data entry is automated, it could 
be performed more quickly. Assuming 4 hours per Form FDA 4057b for 24 
applications, we estimate a total burden of 96 hours for this new 
activity. FDA does not believe the recordkeeping burden will be 
affected by the addition of the form.
    The new total burden for the collections of information in this 
rulemaking are estimated to be 22,610 reporting hours and 52 
recordkeeping hours for a total of 22,662 hours. In compliance with the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3407(d)), the Agency has 
submitted the information collection provisions of this proposed rule 
to OMB for review. These requirements will not be effective until FDA 
obtains OMB approval. FDA will publish a notice concerning OMB approval 
of these requirements in the Federal Register.

    Dated: March 4, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-04828 Filed 3-9-20; 8:45 am]
 BILLING CODE 4164-01-P