[Federal Register Volume 81, Number 250 (Thursday, December 29, 2016)]
[Rules and Regulations]
[Pages 95863-95869]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31370]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1105

[Docket No. FDA-2016-N-1555]


Refuse To Accept Procedures for Premarket Tobacco Product 
Submissions

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule 
describing when FDA will refuse to accept a tobacco product submission 
(or application) because the application has not met a minimum 
threshold for acceptability for FDA review. Under the rule, FDA will 
refuse to accept a tobacco product submission, for example, that is not 
in English, does not pertain to a tobacco product, or does not identify 
the type of submission. By refusing to accept submissions that have the 
deficiencies identified in the proposed rule, FDA will be able to focus 
our review resources on submissions that meet a threshold of 
acceptability and encourage quality submissions.

DATES: This rule is effective January 30, 2017.

FOR FURTHER INFORMATION CONTACT: Annette Marthaler or Paul Hart, Office 
of Regulations, Center for Tobacco Products (CTP), Food and Drug 
Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New 
Hampshire Ave., Silver Spring, MD 20993-0002, 877-287-1373, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Executive Summary

A. Purpose of the Rule

    FDA is issuing this refuse to accept rule to identify deficiencies 
that will result in FDA's refusal to accept certain tobacco product 
submissions under sections 905, 910, and 911 of the Federal Food, Drug, 
and Cosmetic Act (the FD&C Act), as amended by the Family Smoking 
Prevention and Tobacco Control Act (Tobacco Control Act) (21 U.S.C. 
387e, 387j, and 387k).\1\ Because these submissions will be refused 
before they enter FDA's review queue, more resources will be available 
for submissions that are ready for further review. This rule 
establishes a refuse to accept process for premarket tobacco product 
submissions, including premarket tobacco product applications (PMTAs), 
modified risk tobacco product applications (MRTPAs), substantial 
equivalence (SE) applications (also called SE reports), and exemption 
requests (including subsequent abbreviated reports).
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    \1\ FDA has published a final rule extending the Agency's 
``tobacco product'' authorities in the FD&C Act to all categories of 
products that meet the statutory definition of ``tobacco product'' 
in the FD&C Act, except accessories of such newly deemed tobacco 
products (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 (81 FR 28974, May 10, 2016) (the Deeming 
rule)). This rule will apply to all tobacco products FDA regulates 
under Chapter IX of the FD&C Act.
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B. Summary of the Major Provisions of the Regulatory Action

    The rule explains when FDA will refuse to accept a premarket 
submission, including PMTAs, MRTPAs, SE applications, and exemption 
requests (including subsequent abbreviated reports). The rule is based 
on FDA's experience in reviewing these submissions. Under the rule, FDA 
will refuse to accept a premarket submission that: (1) Does not pertain 
to a tobacco product; (2) is not in English (or does not include a 
complete translation); (3) is submitted in an electronic format that 
FDA cannot process, read, review, or archive; (4) does not include the 
applicant's contact information; (5) is from a foreign applicant and 
does not include the name and contact information of an authorized U.S. 
agent (authorized to act on behalf of the applicant for the 
submission); (6) does not include a required form(s); (7) does not 
identify the tobacco product; (8) does not identify the type of 
submission; (9) does not include the signature of a responsible 
official authorized to represent the applicant; or (10) does not 
include an environmental assessment or claim of a categorical 
exclusion, if applicable. Under the rule, if FDA refuses to accept the 
submission, FDA will send the contact (if available) a notification. If 
the submission is accepted for further review, FDA will send an 
acknowledgement letter.

II. Background

    FDA published two rulemaking documents concerning refuse to accept 
procedures in the Federal Register of August 8, 2016: A direct final 
rule (81 FR 52329) and a companion proposed rule (81 FR 52371). We 
published the direct final rule because we believed that the rule was 
noncontroversial, and we did not anticipate that it would receive any 
significant adverse comments. As a companion to the direct final rule, 
we published a proposed rule with the same codified language published 
in the proposed rules section of the Federal Register. The companion 
proposed rule provides a procedural framework to finalize the rule in 
the event that the direct final rule receives any adverse comment and 
is withdrawn. We received adverse comment on the direct final rule and 
withdrew the direct final rule by issuing a notice in the Federal 
Register of November 16, 2016 (81 FR 80567). We are now finalizing the 
proposed rule and responding to the comments we received.

[[Page 95864]]

III. Purpose and Legal Authority

A. Purpose

    FDA is issuing this refuse to accept rule to efficiently handle 
submissions that do not meet a threshold of acceptability for FDA 
review (e.g., the submission lacks certain information FDA needs for 
substantive review of the submission). Currently, FDA often expends 
extensive time and resources in attempts to obtain information and 
resolve the deficiencies identified in the rule simply to begin 
substantively processing the submission. FDA expects that this rule 
will enhance the quality of the submissions and that submissions will 
move expeditiously through the review process. In addition, this rule 
will help submitters better understand the common hurdles FDA 
encounters in conducting a substantive review of submissions.
    The rule identifies deficiencies that FDA has seen across types of 
premarket submissions and will result in FDA refusing to accept the 
submission. This rule applies to all tobacco product applications; we 
note that there are additional deficiencies that are not covered in 
this rule that may arise for specific types of premarket submissions 
that would also result in FDA's refusal to accept that specific type of 
premarket submission (e.g., omission of labeling for a PMTA that is 
required under section 910(b)(1)(F) of the FD&C Act).
    FDA's refusal to accept a tobacco product submission does not 
preclude an applicant from resubmitting a new submission that addresses 
the deficiencies. In addition, acceptance of a submission does not mean 
that FDA has determined that the submission is complete, rather only 
that the submission meets the basic, minimum threshold for acceptance. 
Substantive review of the submission will begin once FDA accepts the 
submission, and for submissions with filing requirements (i.e., PMTAs 
and MRPTAs), once filed. This rule establishes a general process for 
refusing to accept submissions for premarket tobacco review, including 
PMTAs, MRTPAs, SE applications, and exemption requests (including 
subsequent abbreviated reports). Because administratively incomplete 
submissions will be refused before FDA begins substantive review, we 
will be able to use our resources on submissions that are more complete 
and better prepared for further review. In addition, FDA intends to 
determine, as soon as practicable, whether the submission will be 
accepted. We intend to determine whether we will refuse to accept most 
premarket submissions under this rule by 21 to 60 days of receipt, with 
less lengthy submissions, such as some exemption requests, taking 
closer to 21 days or fewer and other more lengthy submissions taking 
closer to 60 days or fewer; however, this range is an initial estimate 
and the actual time required may vary depending on the volume of 
submissions received at any one time. FDA remains committed to an 
efficient product review process and intends to establish and implement 
performance goals for this action once it has experience with the 
volume of submissions it will receive for newly deemed tobacco 
products. FDA expects the performance goals to be generally similar to 
other Agency performance goals, i.e. a certain percentage of refuse to 
accept determinations made within a defined period of time, and with 
the percentage rising over time.

B. Legal Authority

    Section 701(a) of the FD&C Act (21 U.S.C. 371(a)) provides FDA with 
the authority to issue regulations for the efficient enforcement of the 
FD&C Act. This rule will allow FDA to more efficiently use our 
resources to review premarket submissions under sections 905, 910, and 
911 of the FD&C Act. FDA has processed and reviewed many submissions 
since the enactment of the Tobacco Control Act, and submissions with 
the deficiencies identified in the rule have been repeatedly identified 
by FDA as reflecting submissions that are incomplete and not prepared 
for further review.

IV. Overview of the Final Rule

    We are finalizing the proposed rule with only editorial changes. 
The rule adds part 1105 (21 CFR part 1105) to title 21, specifically 
Sec.  1105.10. Section 1105.10 provides that FDA will refuse to accept, 
as soon as practicable, PMTAs, MRTPAs, SE applications, and exemption 
requests (including subsequent abbreviated reports) for the reasons 
listed in paragraphs (a)(1) through (a)(10), if applicable.

V. Comments on the Proposed Rule

    We consider any comments that were submitted on the direct final 
rule to have been submitted on the proposed rule. We received two sets 
of comments on the proposed rule, one from a tobacco product 
manufacturer and another from a public health group. In general, one of 
the commenters expressed strong support for this rule, asking that it 
be applied to a broader set of applications, while the other commenter 
identified concerns with the rulemaking, including that ``promulgating 
a direct final rule was procedurally improper.'' This commenter 
suggested that FDA withdraw the rule in its entirety and issue any 
future rule only after engaging in notice and comment rulemaking. This 
rulemaking, however, did provide both notice and an opportunity for 
comments. As previously noted, FDA withdrew the direct final rule and 
is proceeding with the rulemaking under the procedural framework of the 
proposed rule. FDA has considered the comments submitted to the docket 
for the rulemaking and responds to the comments in the following 
paragraphs.
    To make it easier to identify comments and our responses, the word 
``Comment,'' in parentheses, will appear before each comment, and the 
word ``Response,'' in parentheses, will appear before each response. We 
have numbered the comments to make it easier to distinguish between 
comments; the numbers are for organizational purposes only and do not 
reflect the order in which we received the comments or any value 
associated with the comment. We have combined similar comments under 
one numbered comment.
    (Comment 1) One commenter suggested that FDA apply the rule to 
provisional substantial equivalence applications submitted by 
manufacturers under section 910(a)(2)(B) of the FD&C Act for new 
tobacco products that were first introduced or delivered for 
introduction into interstate commerce between February 15, 2007, and 
March 22, 2011.
    (Response) FDA disagrees with this comment. We do not believe that 
this rule should be applied retroactively to refuse to accept 
submissions submitted before the rule is effective. While the refuse to 
accept criteria represent a minimum threshold that applications should 
be able to meet, we believe that applying this rule retroactively would 
be unfair to applicants because they had no notice that they would be 
subject to the rule's requirements.
    (Comment 2) One commenter suggested that FDA apply this 
``commonsense regulation'' to premarket submissions for newly deemed 
tobacco products submitted during the compliance period announced in 
the Deeming rule.
    (Response) FDA notes that, as explained in the proposed rule, the 
rule once effective, will apply to premarket submissions for all 
tobacco products, including those that are for products covered by the 
Deeming rule.
    (Comment 3) One commenter requested that FDA revise and expand the 
requirements of the rule to allow FDA to refuse to accept substantial 
equivalence applications that fail to

[[Page 95865]]

comply with certain criteria that relate to the substantial equivalence 
pathway, such as creating product-identifying information requirements 
for predicate products.
    (Response) FDA disagrees with this comment. The rule creates a 
minimum threshold of acceptability for all premarket submissions, 
regardless of the type of submission, and is not intended to address 
content specific to only one type of premarket submission. FDA plans to 
consider including refuse to accept criteria that are specific to a 
particular premarket pathway as part of future rulemakings. For 
example, FDA has already issued one such rule, ``Tobacco Products, 
Exemptions From Substantial Equivalence Requirements,'' which contains 
refuse to accept criteria relating specifically to exemption requests 
(July 5, 2011, 76 FR 38961).
    (Comment 4) One commenter argued that FDA lacks the legal authority 
to implement the rule. The commenter stated that because the Tobacco 
Control Act does not set forth content requirements for substantial 
equivalence applications or exemption requests, FDA has no statutory 
justification for pre-review of those submissions. The commenter 
further stated that while the Tobacco Control Act does set forth 
content requirements for premarket tobacco product applications and 
modified risk tobacco product applications that grant FDA authority to 
conduct filing reviews of those submissions, FDA lacks the statutory 
authority to conduct a separate acceptance review as part of the pre-
review of an application. In sum, the commenter argued that FDA does 
not have the statutory authority, either explicit or implicit, to 
refuse to accept tobacco product submissions.
    (Response) FDA disagrees with this comment. As described in section 
III.B of the rule, section 701(a) grants FDA the authority to issue 
regulations for the efficient enforcement of the FD&C Act. As also 
discussed in the proposed rule, this rule will allow FDA to efficiently 
enforce the premarket review requirements of sections 905, 910, and 911 
of the FD&C Act by allowing FDA to refuse to accept submissions that do 
not meet basic criteria and focus its resources on those submissions 
that are ready for review.
    (Comment 5) One commenter argued that unless FDA establishes a time 
by which FDA will refuse to accept a premarket submission, the rule is 
legally problematic for a number of reasons. While two of the specific 
reasons are discussed in this document in separate comments and 
responses, overall, the commenter suggested that FDA should, similar to 
its approach for new drug applications and premarket approval 
applications for medical devices, create a limit of 15 days in which to 
determine whether it will refuse to accept a premarket submission.
    (Response) FDA declines the suggestion that FDA adopt a 15-day time 
limit similar to the refuse to accept review periods for refuse to 
accept notifications for 510(k) and premarket approval applications 
established by the Center for Devices and Radiological Health (CDRH). 
CDRH has had a significantly longer time reviewing such applications 
and has gained extensive experience doing so. CTP currently lacks 
sufficient experience reviewing tobacco product submissions to develop 
specific timeframes. Moreover, there is some uncertainty regarding the 
types and number of applications that manufacturers will choose to 
submit for products covered by the Deeming rule and regarding the 
precise timing of such submissions. Given the size of the industry and 
the number of newly deemed products on the market, FDA anticipates a 
large influx of applications, many of which could be at the end of the 
initial compliance periods for each premarket pathway. It is likely 
that many applicants will have no experience with the FDA premarket 
review process, so the quality of the submissions is likewise very 
difficult to predict. Due to this uncertainty and the difficulty 
predicting the level of resources FDA will have to expend as a result, 
FDA is not prepared at this time to commit to a single time limit for 
all submissions. Instead, FDA is providing an estimated timeframe in 
which it intends to determine whether to accept submissions: FDA 
intends to make the determination of whether it will accept an 
application for review based upon the requirements in the rule by 21 to 
60 days of receipt. Further, we intend to establish performance goals 
or other timeframes once we gain sufficient experience.
    (Comment 6) One commenter argues that the absence of a time limit 
in the rule poses a problem under the First Amendment. Specifically, 
the commenter alleges that FDA's premarket review of tobacco product 
submissions, particularly with regard to MRTPAs, are prior restraints 
on speech; thus, the lack of a time limit for FDA to make acceptance 
determinations allows the Agency to delay the applicant's truthful and 
non-misleading speech indefinitely.
    (Response) FDA disagrees with the commenter's assertion that the 
rule's provisions are problematic under the First Amendment. First, as 
the commenter acknowledges in a footnote, members of the tobacco 
industry challenged the MRTP provisions, including the absence of a 
time limit, on First Amendment grounds, and the Sixth Circuit rejected 
that challenge and upheld the MRTP provisions (Discount Tobacco v. 
United States, 674 F.3d 509, 537 (6th Cir. 2012)). Second, the 
premarket review process is not unique to FDA's regulation of tobacco 
and in fact is employed widely across most of FDA's product areas. The 
commenter singles out the MRTP review process as particularly 
problematic, but they misapprehend the structure of the provision, 
which imposes no direct restriction on speech. Rather, it requires 
premarket review before a product may be introduced into interstate 
commerce and defines such product in part by reference to its 
promotional claims. Courts have upheld FDA premarket reviews in other 
product areas based on a similar scheme. See, e.g., United States v. 
LeBeau, 2016 U.S. App. LEXIS 12375 (7th Cir. 2016); Whitaker v. 
Thompson, 353 F.3d 947 (D.C. Cir. 2004); United States v. Cole, 84 F. 
Supp. 3d 1159, 1166 (D. Or. 2015). Third, there is a split in authority 
regarding whether the prior restraint doctrine applies to commercial 
speech; the Sixth Circuit in Discount Tobacco found that the doctrine 
did not apply to evaluation of the MRTP provisions (674 F.3d at 532-
33). Fourth, even assuming that the marketing of a tobacco product is 
speech to which the prior restraint doctrine could possibly apply, the 
process established here would satify the requirements of that 
doctrine. First, prior restraints are not acceptable where they place 
``unbridled discretion in the hands of a government official or 
agency.'' (FW/PBS, Inc. v. Dallas, 493 U.S. 215, 225-226 (1990) 
(plurality opinion).) Here, however, the rule lays out 10 basic 
requirements for tobacco product applications which, if not met, will 
cause FDA to refuse to accept the submission. Further, when assessing 
whether a submission meets that minimum threshold of acceptability, FDA 
will look only to whether the submission is facially complete and it 
will not conduct a substantive review. Second, the prior restraint 
doctrine requires that decisions ``must be issued within a reasonable 
period of time.'' (City of Littleton v. Z.J. Gifts D-4, L.L.C, 541 U.S. 
774, 780 (2004).) For instance, in a case involving FDA premarket 
review of health claims for dietary supplements, the Second Circuit 
held that a 540-day period was permissible ``given the need to protect 
consumers before any harm occurs,'' to ``evaluate the evidence in 
support of labeling

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claims,'' and to develop ``a record on the matter so that a court can 
determine whether the regulated speech is, in fact, truthful and non-
misleading.'' (Nutritional Health Alliance v. Shalala, 144 F.3d 220 (2d 
Cir. 1998).) Furthermore, as the district court in the Discount Tobacco 
case noted, the Administrative Procedure Act (APA) ``imposes a general 
but nondiscretionary duty upon an administrative agency to pass upon a 
matter presented to it `within a reasonable time,' 5 U.S.C. 555(b), and 
authorizes a reviewing court to `compel agency action unlawfully 
withheld or unreasonably delayed,' 5 U.S.C. 706(1).'' (Commonwealth 
Brands, Inc. v. United States, 678 F. Supp. 2d 512, 533 (W.D. Ky. 
2010).) The APA requirement that the Agency act on matters before it 
``within a reasonable time,'' in conjunction with FDA's estimated 
timeframes and the performance goals for refuse to accept review that 
FDA intends to establish, indicate that FDA will not leave applications 
``in limbo,'' as claimed by the commenter, but will act on them in a 
reasonable amount of time. For all of these reasons, the rule's 
provisions do not constitute an unconstitutional prior restraint.
    (Comment 7) One commenter argued that implementing the rule would 
allow FDA to deprive manufacturers of the valuable substantive right to 
market their products during the compliance period for deemed products 
with no hearing and no substantive review, which is contrary to 
Congress' intent in the Tobacco Control Act. The commenter further 
argued that the Tobacco Control Act allows FDA to require certain 
tobacco products to be taken off of the market only upon making a 
substantive determination that the action is warranted under statutory 
standards, and thus FDA cannot require that products be removed from 
the market without any such substantive review.
    (Response) FDA disagrees with this comment. Under the FD&C Act, 
generally, a new tobacco product may not be introduced or delivered for 
introduction into interstate commerce unless it is subject to a 
marketing order under section 910(c)(1)(A)(i), FDA has issued an order 
finding the new tobacco product substantially equivalent to a predicate 
product, or FDA has issued an exemption from the requirements of 
substantial equivalence. The final Deeming rule, issued with notice and 
an opportunity for comment, extends this requirement to newly regulated 
products that are not grandfathered (i.e., marketed as of February 15, 
2007). Thus, as of August 8, 2016, marketing these products without FDA 
authorization is prohibited by statute. However, FDA is affording 
staggered compliance periods during which FDA does not intend to 
enforce the premarket review requirements. These compliance periods are 
general statements of policy that do not establish any rights for any 
person, and are not binding on FDA or the public. (See e.g., 
Professionals and Patients for Customized Care v. Shalala, 56 F.3d 592 
(5th Cir. 1995).) The commenter gives a vague reference to the rule 
depriving manufacturers of a ``substantive right'' to market with no 
hearing or substantive review, but without citing any authority for 
such a right. Irrespective of the rule, a manufacturer does not have a 
right to market a product that is in violation of the FD&C Act because 
it does not have a required premarket authorization.
    (Comment 8) One commenter stated that FDA should allow 
manufacturers to amend applications that FDA finds to be deficient and 
consider the amended applications to be received as of their original 
submission dates. The commenter explained that this approach would not 
tie up Agency resources because FDA could simply notify an applicant of 
any deficiencies and suspend substantive review until the applicant 
resolves those issues and, as such, there is no valid reason for 
requiring that applications be resubmitted rather than amended.
    (Response) FDA disagrees with this suggestion. Creating a queue of 
deficient premarket submissions that FDA must track and manage is the 
type of inefficient process that FDA seeks to eliminate from the 
premarket submission review process with the rule. A queue for plainly 
deficient submissions will require a redirection of FDA resources away 
from more complete, quality submissions. Additionally, we disagree with 
the suggestion that we should consider amended submissions to have been 
received by the original submission date. This would allow 
manufacturers to submit woefully deficient premarket submissions and 
rely on FDA to identify deficiencies to be resolved.
    (Comment 9) One commenter argued that FDA should withdraw the rule 
and instead issue rules specifying the content that must be contained 
in each type of application because without such application-specific 
rules, the rule is unconstitutionally vague. The commenter further 
explained that without the promulgation of such content regulations, it 
considers the rule to violate the Due Process Clause of the 5th 
Amendment as well as the APA because it would allow FDA to deny 
applications without fully explaining application content requirements 
to applicants. Additionally, the comment asserts that the rule is 
unduly vague under the Due Process Clause and the APA on the basis that 
some of the criteria are either ``ill-defined or entirely undefined.''
    (Response) FDA disagrees with this comment. The rule is not 
impermissibly vague as it provides applicants with fair notice of 10 
criteria by which FDA will refuse to accept a premarket submission. 
These criteria are not specific to the requirements of any one 
premarket pathway but instead include basic parameters that apply to 
all premarket submissions. Detailed criteria that are specific to each 
premarket pathway are not necessary to implementing a rule that applies 
to all types of premarket submissions generally without any 
consideration of content specific to each premarket pathway. Any 
additional grounds for which FDA may refuse a premarket submission 
exist independently from this rulemaking; therefore, the vagueness of 
such grounds, if any, is not attributable to the rule and does not 
cause it to violate the Due Process clause of the 5th Amendment or the 
APA. Further, the comment incorrectly asserts that some of the criteria 
required by the rule are unduly vague under the Due Process Clause and 
the APA. A law is impermissibly vague if it does not give ``a person of 
ordinary intelligence a reasonable opportunity to know what is 
prohibited.'' Grayned v. City of Rockford, 408 U.S. 104, 108 (1972). To 
the extent that the commenter identifies concerns with specific 
requirements of the rule, we address them in the responses to comments 
10-14; however, FDA believes that the requirements of this rule are 
sufficiently clear to give submitters a reasonable opportunity to be 
aware of what information must be included with a tobacco product 
application.
    (Comment 10) One commenter argued that FDA must edit the rule so 
that it comprehensively states all potential refuse to accept criteria 
for each premarket pathway and commit to accepting all submissions that 
meet those specific criteria because granting FDA discretion to refuse 
to accept submissions on the basis of criteria not specified in this 
rule violates the principles of fair notice embodied in the 
Constitution and the APA.
    (Response) FDA disagrees. Under Sec.  1105.10(b), FDA ``may accept 
the submission'' if it ``finds that none of the reasons in paragraph 
(a) of this section exists for refusing to accept a premarket 
submission.'' The use of the word

[[Page 95867]]

``may'' in this section reflects the fact that this rule addresses the 
basic threshold of acceptability that all premarket submissions must 
meet; however it does not address other grounds on which FDA could 
refuse to accept a specific type of premarket submission, such as the 
omission of labeling from a PMTA that is required by section 
910(b)(1)(F) of the FD&C Act. Any additional grounds on which FDA may 
refuse to accept a premarket submission exist independently from this 
rulemaking and are outside of its scope.
    (Comment 11) One commenter argues that FDA's discussion in the 
preamble of the proposed rule regarding ``other information'' that FDA 
recommends be included as part of the product-identifying information 
submitted under Sec.  1105.10(a)(7) should either be deleted or 
modified to provide a full and complete description of what ``other 
information'' applicants should provide. The commenter also suggests 
that FDA must state whether failure to provide such information would 
be grounds for FDA to refuse to accept a submission.
    (Response) FDA disagrees with this comment. Section 1105.10(a)(7) 
specifically lists the product-identifying information that is required 
under the rule: The manufacturer of the tobacco product; the product 
name, including the brand and subbrand; the product category and 
subcategory; package type and package quantity; and characterizing 
flavor. The preamble of the proposed rule notes that other information 
may be needed to identify the product, such as product descriptors that 
are not a part of the product name (e.g., premium), but it merely 
requests such information be submitted to facilitate FDA's review. 
Failure to include additional product-identifying information beyond 
those specifically listed in Sec.  1105.10(a)(7) is not grounds for FDA 
to refuse to accept a submission under the rule.
    (Comment 12) One commenter argued that FDA must either remove the 
requirement in Sec.  1105.10(a)(7) that applicants specify the category 
and subcategory of the tobacco product or provide a list of all 
potential categories and subcategories. The commenter further noted 
that FDA could require a uniform system of product identification under 
21 U.S.C. 387e(e) (section 905(e) of the FD&C Act), but it has not yet 
issued a regulation doing so.
    (Response) FDA disagrees with this comment. The rule requires 
applicants to describe the category and subcategory of the tobacco 
product that is the subject of the premarket submission. This is a 
requirement to provide basic product-identifying information, such as 
describing the product category as ``Smokeless Tobacco Product'' and 
the subcategory as ``Dissolvable,'' which in no way creates a rigid 
system of product identification with which an applicant must 
comply.\2\ Creating an exhaustive product categorization system is not 
necessary for applicants to describe the product's category and 
subcategory and in some cases may not allow applicants to accurately 
describe new tobacco products that fall into novel categories or 
subcategories. Table 1 in the preamble of the proposed rule provides 
some recommendations on how an applicant may satisfy this requirement, 
but it is not intended to be an exhaustive list (for example, although 
recommendations for waterpipes were not included in table 1, 
submissions on waterpipes should include similar information). While 
the table is not an exhaustive list of every tobacco product category 
and subcategory that exists, manufacturers have enough information to 
reasonably understand how to comply with the requirement and can 
provide information based on internal classifications. Applicants 
unable to identify the category or subcategory of the tobacco product 
that will be the subject of a premarket submission are encouraged to 
contact FDA prior to submission.
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    \2\ Applicants should note that some categories are defined in 
section 900 of the FD&C Act (e.g., cigarette (900(3)), cigarette 
tobacco (900(4)), roll-your-own tobacco (900(15)), smokeless tobacco 
(900(18))).
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    (Comment 13) One commenter argued that FDA should not require an 
applicant to identify the submission type as part of a premarket 
submission because the list of submission types provided to implement 
Sec.  1105.10(a)(8) is incomplete. To support this statement, the 
commenter notes that the list in the preamble of the proposed rule does 
not mention Product Quantity Change SE Reports as a potential premarket 
submission type.
    (Response) FDA disagrees with the suggestion that manufacturers 
should not be required to identify the type of application they are 
submitting and that the list of submission types described in the 
preamble of the proposed rule is incomplete. Identifying the type of 
submission is necessary for FDA to review a premarket submission 
because it enables FDA to determine the appropriate decisional standard 
to apply to a submission (e.g., whether it is a PMTA subject to the 
requirements of section 910 of the FD&C Act or an MRTPA subject to the 
requirements of section 911 of the FD&C Act). The commenter is also 
incorrect in its assertion that the proposed rule's discussion of the 
types of premarket submissions is incomplete. The only example the 
commenter provides to support this assertion is the Product Quantity 
Change SE Reports, which are SE applications. The preamble of the 
proposed rule described the types of premarket submissions, which are 
PMTAs, MRTPAs, SE applications, and exemption requests (and subsequent 
abbreviated reports). Applicants are welcome to provide additional 
information regarding their submission type, such as specifying that 
their SE application is being submitted for a product quantity change, 
provided that the basic submission type remains clear. Applicants 
unsure of how to identify the type of application that they are 
submitting are encouraged to contact FDA prior to submission.
    (Comment 14) One commenter argued that FDA should remove the 
requirement that a premarket submission be accompanied by required 
forms because FDA has yet to require any forms and it is unclear what 
those forms may eventually require. The commenter stated that if and 
when FDA creates required forms, it can issue regulations providing how 
and when the forms must be submitted.
    (Response) We disagree with the suggestion that this requirement 
should be removed from the rule. As described in section IV of the 
proposed rule, if and when FDA issues any forms it would need to do so 
in accordance with applicable requirements, e.g., notice and 
opportunity to comment on such forms in accordance with rulemaking 
procedures and the Paperwork Reduction Act of 1995 and rulemaking under 
the APA. We have chosen to include the form submission requirement in 
this rule to provide notice that the failure to submit any required 
forms, if and whenever they are issued, will be grounds for refusing to 
accept a premarket submission.
    (Comment 15) One commenter argued that FDA should not require 
applicants to identify whether a product has a characterizing flavor 
until FDA has issued a full explanation of what it considers to be a 
characterizing flavor and how it expects manufacturers to determine 
what the characterizing flavor of a tobacco product is. The commenter 
also argued that the requirement to identify a characterizing flavor 
has no statutory basis and is not necessary to identify a product in 
light of all other information FDA is requiring, such as the product 
name, brand, subbrand, category, and subcategory.
    (Response) FDA disagrees with this comment. This requirement, along 
with

[[Page 95868]]

the other product-identifying information in Sec.  1105.10(a)(7), will 
identify to FDA the specific tobacco product that is the intended 
subject of the application. As explained in the preamble to the 
proposed rule, FDA is requiring this product-identifying information 
under section 701 of the FD&C Act to efficiently enforce premarket 
review requirements for tobacco requirements. For example, FDA needs to 
be able to distinguish between products that have the same brand and 
subbrand, but different flavors (e.g., brand X menthol or brand X 
cinnamon). This also helps ensure that FDA ultimately issues an order 
that addresses the intended tobacco product. For the purposes of the 
refuse to accept process and to appropriately identify the specific 
product that is the subject of the submission, FDA is solely looking to 
see how the applicant identifies the tobacco product as having no 
characterizing flavor or having a particular characterizing flavor. 
Thus, for example, a firm would give ``menthol'' as the characterizing 
flavor a tobacco product it identifies as ``Brand A menthol''. At the 
acceptance stage, FDA would not review beyond how the product is 
identified, such as to determine whether the product contains a 
different or additional characterizing flavor. Applicants that have 
questions regarding how to describe their product's characterizing 
flavor are encouraged to contact FDA prior to submission.
    (Comment 16) One commenter argued that FDA should either modify the 
rule so that it contains procedures to resolve disputes regarding 
whether FDA should have refused to accept an application, or it should 
specify whether the procedures for internal Agency review of decisions 
specified in Sec.  10.75 (21 CFR 10.75) applies.
    (Response) The procedures for internal Agency review of decisions 
in Sec.  10.75 apply to a decision of an FDA employee, other than 
commissioner, on a matter. Applicants seeking review of a refuse to 
accept decision may use this mechanism or consider other mechanisms set 
out in part 10. FDA expects, however, that most applicants will find 
that addressing any deficiencies in the application will quickly 
resolve issues.

VI. Paperwork Reduction Act of 1995

    FDA concludes that this rule contains no collection of information. 
Therefore, clearance by the Office of Management and Budget under the 
Paperwork Reduction Act of 1995 is not required.

VII. Federalism

    We have analyzed this rule in accordance with the principles set 
forth in Executive Order 13132. We have determined that the rule does 
not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, we conclude that the rule 
does not contain policies that have federalism implications as defined 
in the Executive Order and, consequently, a federalism summary impact 
statement is not required.

VIII. Tribal Consultation

    We have analyzed this rule in accordance with the principles set 
forth in Executive Order 13175. We have determined that the rule does 
not contain policies that would have substantial direct effects on one 
or more Indian tribes, on the relationship between the Federal 
Government and Indian tribes, or on the distribution of power and 
responsibilities between the Federal Government and Indian tribes. 
Accordingly, we conclude that the rule does not contain policies that 
have tribal implications as defined in the Executive Order; 
consequently, a tribal summary impact statement is not required.

IX. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(h) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

X. Economic Analysis of Impacts

    We have examined the impacts of the rule under Executive Order 
12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 
601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). 
Executive Orders 12866 and 13563 direct us to assess all costs and 
benefits of available regulatory alternatives and, when regulation is 
necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, public health and safety, 
and other advantages; distributive impacts; and equity). We believe 
that this rule is not a significant regulatory action as defined by 
Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because this rule establishes a procedure that FDA is 
responsible for implementing and has the effect of providing all 
entities useful feedback on the readiness of a submission, we certify 
that the rule will not have a significant economic impact on a 
substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $146 million, using the most current (2015) Implicit 
Price Deflator for the Gross Domestic Product. This rule does not 
result in expenditure in any year that meets or exceeds this amount.
    This rule identifies 10 significant and common deficiencies in 
premarket tobacco submissions that will cause FDA to refuse to accept 
them. Encouraging submissions that are free of the deficiencies listed 
in this rule does not represent a change in Agency expectations. One of 
the 10 deficiencies is required by statute (i.e., must be a tobacco 
product). One of the deficiencies is required by another regulation 
(i.e., must comply with requirements related to environmental 
assessments or exclusions from such assessments). The remaining eight 
deficiencies are basic expectations for an application to enter the 
review process. Therefore, this rule clarifies these expectations. This 
clarification will result in cost savings for both the applicant and 
FDA as less time is spent by FDA working with applicants to address 
these significant deficiencies. Applicants have clarity about basic 
expectations regarding requirements for acceptance of premarket 
applications. In addition, refusing to accept submissions with these 
deficiencies will allow Agency staff to more efficiently process 
submissions and quickly move those submissions without these 
deficiencies into review of substantial scientific issues.

List of Subjects in 21 CFR Part 1105

    Administrative practices and procedures, Tobacco, Tobacco products.


0
Therefore, under the Federal Food, Drug, and Cosmetic Act, and under 
authority delegated to the Commissioner

[[Page 95869]]

of Food and Drugs, 21 CFR chapter I is amended by adding part 1105, 
consisting of Sec.  1105.10, to read as follows:

PART 1105--GENERAL

    Authority: 21 U.S.C. 371(a), 387e, 387j, and 387k.

Subpart A--General Submission Requirements


Sec.  1105.10  Refusal to accept a premarket submission.

    (a) FDA will refuse to accept for review, as soon as practicable, a 
premarket tobacco product application, modified risk tobacco product 
application, substantial equivalence application, or exemption request 
or subsequent abbreviated report for the following reasons, if 
applicable:
    (1) The submission does not pertain to a tobacco product as defined 
in 21 U.S.C. 321(rr).
    (2) The submission is not in English or does not contain complete 
English translations of any information submitted within.
    (3) If submitted in an electronic format, the submission is in a 
format that FDA cannot process, read, review, and archive.
    (4) The submission does not contain contact information, including 
the applicant's name and address.
    (5) The submission is from a foreign applicant and does not 
identify an authorized U.S. agent, including the agent's name and 
address, for the submission.
    (6) The submission does not contain a required FDA form(s).
    (7) The submission does not contain the following product-
identifying information: The manufacturer of the tobacco product; the 
product name, including the brand and subbrand; the product category 
and subcategory; package type and package quantity; and characterizing 
flavor.
    (8) The type of submission is not specified.
    (9) The submission does not contain a signature of a responsible 
official, authorized to represent the applicant, who either resides in 
or has a place of business in the United States.
    (10) For premarket tobacco applications, modified risk tobacco 
product applications, substantial equivalence applications, and 
exemption requests only: The submission does not include a valid claim 
of categorical exclusion in accordance with part 25 of this chapter, or 
an environmental assessment.
    (b) If FDA finds that none of the reasons in paragraph (a) of this 
section exists for refusing to accept a premarket submission, FDA may 
accept the submission for processing and further review. FDA will send 
to the submitter an acknowledgement letter stating the submission has 
been accepted for processing and further review and will provide the 
premarket submission tracking number.
    (c) If FDA finds that any of the reasons in paragraph (a) of this 
section exist for refusing to accept the submission, FDA will notify 
the submitter in writing of the reason(s) and that the submission has 
not been accepted, unless insufficient contact information was 
provided.

    Dated: December 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31370 Filed 12-28-16; 8:45 am]
 BILLING CODE 4164-01-P