[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
[[Page 95866]]
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]
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