[Federal Register Volume 81, Number 152 (Monday, August 8, 2016)]
[Rules and Regulations]
[Pages 52329-52335]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18534]


-----------------------------------------------------------------------

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: Direct final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is issuing a 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 rule, FDA will be able to focus our 
review resources on submissions that meet a threshold of acceptability 
and encourage quality submissions. FDA is issuing this action directly 
as a final rule because we believe there is little likelihood that we 
will receive any significant adverse comments opposing the rule given 
the specific deficiencies identified that will result in FDA's refusal 
to accept the submission.

DATES: This rule is effective December 21, 2016. Submit either 
electronic or written comments on this direct final rule by October 24, 
2016. If we receive no significant adverse comments during the 
specified comment period, we intend to publish a confirmation document 
on or before the effective date by publication of a document in the 
Federal Register.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that

[[Page 52330]]

identifies you in the body of your comments, that information will be 
posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-N-1555 for ``Refuse to Accept Procedures for Premarket Tobacco 
Submissions.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at http://www.regulations.gov or at the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

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 under direct final rule 
procedures. The rule identifies 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).
---------------------------------------------------------------------------

    \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)). This direct final 
rule applies to all tobacco products FDA regulates under Chapter IX 
of the FD&C Act.
---------------------------------------------------------------------------

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. 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. Direct Final Rulemaking

    In the Federal Register of November 21, 1997 (62 FR 62466), FDA 
described the procedures on when and how the Agency will employ direct 
final rulemaking (this guidance document may be accessed at http://www.fda.gov/regulatoryinformation/guidances/ucm125166.htm). We have 
determined that this rule is appropriate for direct final rulemaking 
because we believe it is noncontroversial and we anticipate no 
significant adverse comments. Consistent with our procedures on direct 
final rulemaking, FDA is publishing elsewhere in this issue of the 
Federal Register a companion proposed rule with the same codified 
language as this direct final rule to add a rule describing when FDA 
would refuse to accept submissions due to deficiencies. The companion 
proposed rule provides a procedural framework within which the rule may 
be finalized in the event that the direct final rule is withdrawn 
because of any significant adverse comments. The comment period for the

[[Page 52331]]

direct final rule runs concurrently with the companion proposed rule.
    We are providing a comment period on the direct final rule of 75 
days after the date of publication in the Federal Register. If we 
receive any significant adverse comments, we intend to withdraw this 
direct final rule action before its effective date by publication of a 
notification in the Federal Register. A significant adverse comment is 
defined as a comment that explains why the rule would be inappropriate, 
including challenges to the rule's underlying premise or approach, or 
would be ineffective or unacceptable without a change. In determining 
whether an adverse comment is significant and warrants terminating a 
direct final rulemaking, we will consider whether the comment raises an 
issue serious enough to warrant a substantive response in a notice and 
comment process in accordance with section 553 of the Administrative 
Procedure Act (5 U.S.C. 553). Comments that are frivolous, 
insubstantial, or outside the scope of the rule will not be considered 
significant or adverse under this procedure. A comment recommending a 
regulation change in addition to those in the rule would not be 
considered a significant adverse comment unless the comment provides a 
reasonable explanation for why the rule would be ineffective without 
the additional change. In addition, if a significant adverse comment 
applies to an amendment, paragraph, or section of this rule and that 
provision can be severed from the remainder of the rule, we may adopt 
as final those provisions of the rule that are not subject of a 
significant adverse comment.
    If any significant adverse comments are received during the comment 
period, FDA will publish, before the effective date of this direct 
final rule, a document withdrawing the direct final rule. If we 
withdraw the direct final rule, any comments received will be applied 
to the proposed rule and will be considered in developing a final rule 
using the usual notice and comment procedures. If FDA receives no 
significant adverse comments during the specified comment period, FDA 
intends to publish a confirmation document, before the effective date 
of the direct final rule, confirming the effective date.

III. Purpose and Legal Authority

A. Purpose

    FDA is issuing this refuse to accept rule as a means of efficiently 
handling 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 the 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 will also result in FDA's refusal to accept that specific type of 
premarket submission (e.g., a PMTA fails to contain specimens of the 
labeling proposed to be used for such tobacco product under section 
910(b)(1)(F) of the FD&C Act).
    FDA's refusal to accept a tobacco product submission will not 
preclude an applicant from resubmitting a new submission that addresses 
the deficiencies. In addition, acceptance of a submission will not mean 
that FDA has determined that the submission is complete, but rather 
only that the submission has met 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 MRTPAs), once filed. The rule establishes a general 
process for refusing to accept submissions for premarket tobacco 
product 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 expect the amount of time 
it takes FDA to make this determination to be relatively quick, 
however, it 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 after the deeming rule becomes effective. FDA expects the 
performance goals to be generally similar to other Agency performance 
goals, i.e. a certain percentage of RTA 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 
authority to issue regulations for the efficient enforcement of the 
FD&C Act. This rule allows 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. Description of the Direct Final Rule

    We are adding part 1105 (21 CFR part 1105) to title 21, 
specifically Sec.  1105.10. Section 1105.10(a) 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 (10), if 
applicable:
     Section 1105.10(a)(1) states that FDA will refuse to 
accept a tobacco product submission that does not pertain to a tobacco 
product. This provision addresses a submission that refers to a product 
that does not meet the definition of a ``tobacco product'' under 
section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)) and, therefore, is 
not subject to FDA's tobacco product authorities.
     Section 1105.10(a)(2) states that FDA will refuse to 
accept a submission that is not in the English language or does not 
contain complete English translations of any information included with 
the submission. FDA is unable to read and process such submissions.
     Section 1105.10(a)(3) provides that FDA will refuse to 
accept a submission if it is provided in an electronic format that FDA 
cannot process, read, review, and archive. As with submissions that are 
not in English (or fail to include an English translation), FDA is 
unable to read and process such submissions. FDA provides information 
on the electronic formats that it can read, process, review, and 
archive at http://www.fda.gov/tobaccoproducts/

[[Page 52332]]

guidancecomplianceregulatoryinformation/manufacturing/default.htm.
     Section 1105.10(a)(4) provides that FDA will refuse to 
accept any submission that does not contain contact information, 
including the applicant's name and address. If a submission omits the 
contact information, FDA will not be able to contact the applicant 
regarding the submission, e.g., with questions or followup related to 
the submission. In this instance, FDA also will likely be unable to 
provide notice of the Agency's refusal to accept the submission under 
Sec.  1105.10(c).
     Section 1105.10(a)(5) provides that FDA will refuse to 
accept a submission from a foreign applicant if the submission does not 
list an authorized U.S. agent, including the agent's U.S. address. FDA 
is requiring identification of a U.S. agent for two reasons. First, a 
U.S. agent is important to help CTP ensure adequate notice is provided 
to applicants for official Agency communications. FDA may be unable to 
confirm that adequate notice of Agency action or correspondence 
concerning premarket submissions is provided to foreign applicants as 
FDA cannot necessarily confirm receipt of correspondence sent 
internationally. Accordingly, the designation of a U.S. agent provides 
an official contact to the Agency who can receive the information or 
documentation on behalf of the applicant. Providing notice regarding 
that application to the U.S. agent will constitute notice to the 
foreign applicant. Second, FDA requires identification of a U.S. agent 
to assist FDA in communication with the foreign applicant and help the 
Agency to efficiently process applications and avoid delays. In many 
instances during the application review process, FDA has reached out 
numerous times to foreign applicants and has either been unable to 
speak with the applicant or unable to directly communicate questions 
and/or concerns. This impediment, which occurs more for foreign 
applicants than domestic applicants, has resulted in delays or 
terminations in the review of specific applications and a slowdown of 
the premarket application process as a whole. A U.S. agent will act as 
a communications link between FDA and the applicant and will facilitate 
timely correspondence between FDA and foreign applicants, including 
responding to questions concerning pending applications and, if needed, 
assisting FDA in scheduling meetings with the foreign applicants to 
resolve outstanding issues before Agency action is taken. Additionally, 
the identified U.S. agent will be authorized to act on behalf of the 
foreign applicant for that specific application.
     Section 1105.10(a)(6) provides that FDA will refuse to 
accept the submission if it does not include any required FDA form(s). 
At the time of this direct final rule, FDA has not yet issued any forms 
to accompany premarket submissions. In the event that FDA does issue 
such a form(s), the Agency will give interested parties notice and 
opportunity to comment on such forms in accordance with rulemaking 
procedures and the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520).
     Section 1105.10(a)(7) provides that FDA will refuse to 
accept a submission that does not contain the following product-
identifying information (for the product that is the subject of the 
submission and, if applicable, for the predicate): The manufacturer of 
the tobacco product; the product name, including brand and subbrand; 
product category (e.g., cigarette) and subcategory (e.g., combusted, 
filtered); package type (e.g., box) and package quantity (e.g., 20 per 
box); and characterizing flavor (i.e., applicants must state the 
characterizing flavor, such as menthol, or state that there is no 
characterizing flavor present in the tobacco product). For example, in 
table 1, FDA has supplied a list of recommended categories and 
subcategories of some tobacco products to assist applicants in 
providing product-identifying information in their submissions. Note 
that there may be other information FDA needs to identify a particular 
product, e.g., descriptors (such as ``premium'') that are separate from 
the product name. If this is the case, such information should be 
provided by the applicant in the initial submission to facilitate FDA's 
efficient review.

          Table 1--Tobacco Product Categories and Subcategories
------------------------------------------------------------------------
        Tobacco product category           Tobacco product subcategory
------------------------------------------------------------------------
Cigarettes.............................  Combusted, Filtered.
                                         Combusted, Non-Filtered.
                                         Combusted, Other.
                                         Non-Combusted.
Roll-Your-Own Tobacco Products.........  Roll-Your-Own Tobacco Filler.
                                         Rolling Paper.
                                         Filtered Cigarette Tube.
                                         Non-Filtered Cigarette Tube.
                                         Filter.
                                         Paper Tip.
                                         Roll-Your-Own Co-Package.
                                         Other.
Smokeless Tobacco Products.............  Loose Moist Snuff.
                                         Portioned Moist Snuff.
                                         Loose Snus.
                                         Portioned Snus
                                         Loose Dry Snuff.
                                         Dissolvable.
                                         Loose Chewing Tobacco.
                                         Portioned Chewing Tobacco.
                                         Smokeless Co-Package.
                                         Other.
ENDS (Electronic Nicotine Delivery       Open E-Liquid.
 System).                                Closed E-Liquid.
                                         Closed E-Cigarette.
                                         Open E-Cigarette.
                                         ENDS Component.

[[Page 52333]]

 
                                         ENDS Co-Package.
                                         ENDS Other.
Cigars.................................  Filtered, Sheet-Wrapped Cigar.
                                         Unfiltered, Sheet-Wrapped
                                          Cigar.
                                         Leaf-Wrapped Cigar.
                                         Cigar Component.
                                         Cigar Tobacco Filler.
                                         Cigar Co-Package.
                                         Other.
Pipe Tobacco Products..................  Pipe.
                                         Pipe Tobacco Filler.
                                         Pipe Component.
                                         Pipe Co-Package.
                                         Other.
------------------------------------------------------------------------

    This product-specific information helps ensure that the product is 
within CTP's purview and enables FDA to appropriately identify the 
specific product that is the subject of the submission. Specifically, 
this information is necessary to both review the submission itself and 
to issue an order that appropriately identifies the tobacco product 
that is subject to the order. For example, an SE submission contains a 
comparison between the predicate and new products. If FDA does not know 
the exact products that are being compared, FDA will be unable to 
sufficiently understand and evaluate the comparison to determine 
whether the products are substantially equivalent. As another example, 
if an applicant does not specify whether its proposed new product 
contains a characterizing flavor, FDA will not be able to issue an 
order as it will not know the specific product for which the applicant 
is seeking an order (e.g., product X menthol or product X cinnamon.)
     Section 1105.10(a)(8) provides that FDA will refuse to 
accept a submission if the applicant fails to indicate the type of 
submission (i.e., PMTA, MRTPA, SE application, or exemption request or 
subsequent abbreviated report), because that information is necessary 
to enable FDA to begin an appropriate review of the submission.
     Section 1105.10(a)(9) provides that FDA will refuse to 
accept a submission if it 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. A signature provides 
assurance to FDA that the submission is both intended by the applicant 
and ready for review. Responsible officials also should be aware that 
under 18 U.S.C. 1001, it is illegal to knowingly and willingly submit 
false information to the U.S. Government.
     Section 1105.10(a)(10) applies only to PMTAs, MRTPAs, SE 
applications, and exemption requests (this subsection does not apply to 
the subsequent abbreviated report). For these submissions, this 
paragraph provides that FDA will refuse to accept the submission if it 
does not include an environmental assessment (EA) or a valid claim of 
categorical exclusion. Under Sec.  25.15(a) (21 CFR 25.15(a)), all 
submissions requesting FDA action require the submission of either a 
claim of categorical exclusion or an EA. Because an EA is required for 
an initial exemption request, it is not also required for an 
abbreviated report, and thus is not a basis for FDA to refuse to accept 
an abbreviated report. In addition, Sec.  25.15(a) provides that FDA 
may refuse to file a submission if the included EA fails to address 
``the relevant environmental issues.'' Because the SE and SE Exemption 
pathways do not include a filing stage, FDA intends to determine such 
adequacy at the acceptance stage for those pathways.\2\ The EA or claim 
of categorical exclusion must be made for the Agency action being 
proposed (e.g., issuance of an SE order for introduction of such new 
tobacco product into interstate commerce for commercial distribution in 
the United States.). For information on preparing an EA, refer to Sec.  
25.40.
---------------------------------------------------------------------------

    \2\ The PMTA and MRTPA pathways, by contrast, have a filing 
stage.
---------------------------------------------------------------------------

    Section 1105.10(b) provides that if FDA does not identify a reason 
under paragraph (a) for refusing to accept a submission, then the 
Agency may accept it for processing and further review. If FDA does 
accept the submission, the Agency intends to send the submitter an 
acknowledgement letter stating that FDA has accepted the submission for 
processing and further review. This letter will also include a 
premarket submission tracking number.
    Section 1105.10(c) provides that if FDA identifies a reason under 
paragraph (a) for refusing to accept a premarket review submission, we 
will notify the applicant in writing of the reason(s) and that FDA has 
not accepted the submission for processing and further review. However, 
FDA will be unable to provide this notification when the contact 
information is insufficient, for example, has not been provided or is 
not legible. If FDA refuses to accept the submission for one or more of 
the reasons stated in Sec.  1105.10, the submitter may revise the 
submission to correct the deficiencies and resubmit it to FDA as a new 
submission.

V. Effective Date

    This direct final rule will be effective 60 days after the comment 
period ends.

VI. Paperwork Reduction Act of 1995

    FDA concludes that this direct final 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 direct final 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.

[[Page 52334]]

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 direct final 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 direct final 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 final rule establishes a procedure that FDA is 
responsible for implementing and has the effect of providing entities 
with useful feedback on the readiness of a submission, we certify that 
the direct final 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 direct final rule 
would 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 environmental considerations). 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 will have clarity about 
basic expectations of the requirements needed for acceptance of 
premarket applications. In addition, refusing to accept submissions 
with these deficiencies allows 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.

    Therefore, under the Federal Food, Drug, and Cosmetic Act, and 
under authority delegated to the Commissioner of Food and Drugs, 21 CFR 
chapter I is amended by adding part 1105 to subchapter K to read as 
follows:

PART 1105--GENERAL

Subpart A--General Submission Requirements
Sec.
1105.10 Refusal to accept a premarket tobacco product submission.

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

Subpart A--General Submission Requirements


Sec.  1105.10  Refusal to accept a premarket tobacco product 
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 an 
environmental assessment, or a valid claim of categorical exclusion in 
accordance with part 25 of this chapter.
    (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.


[[Page 52335]]


    Dated: August 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-18534 Filed 8-5-16; 8:45 am]
 BILLING CODE 4164-01-P