
[Federal Register Volume 81, Number 152 (Monday, August 8, 2016)]
[Proposed Rules]
[Pages 52371-52377]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18533]


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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: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a proposed 
rule describing when FDA would 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 proposed 
rule, FDA would 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

[[Page 52372]]

type of submission. By refusing to accept submissions that have the 
deficiencies identified in the proposed rule, FDA would be able to 
focus our review resources on submissions that meet a threshold of 
acceptability and encourage quality submissions. If we receive any 
significant adverse comments that warrant terminating the direct final 
rule, we will consider such comments on the proposed rule in developing 
the final rule.

DATES: Submit either electronic or written comments on the proposed 
rule by October 24, 2016.

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 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 
Product 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, 
CTPRegulations@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Executive Summary

A. Purpose of the Proposed Rule

    FDA is proposing this refuse to accept rule as a companion to the 
direct final rule issued elsewhere in this issue of the Federal 
Register. The proposed rule would identify deficiencies that would 
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 would be refused 
before they enter FDA's review queue, more resources would be available 
for submissions that are ready for further review. This proposed rule 
would establish 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)). This proposed 
rule would 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 proposed rule explains when FDA would refuse to accept a 
premarket submission, including PMTAs, MRTPAs, SE applications, and 
exemption requests (including subsequent abbreviated reports). The 
proposal is based on FDA's experience in reviewing these submissions. 
Under the proposed rule, FDA would 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

[[Page 52373]]

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 proposed rule, if FDA 
refuses to accept the submission, FDA would send the contact (if 
available) a notification. If the submission is accepted for further 
review, FDA would send an acknowledgement letter.

II. Direct Final Rulemaking

    This proposed rule is a companion to the direct final rule with the 
same codified language published in the final rules section of this 
issue of the Federal Register. This companion proposed rule provides 
the procedural framework to finalize the rule in the event that the 
direct final rule receives any adverse comment and is withdrawn. The 
comment period for this companion proposed rule runs concurrently with 
the comment period for the direct final rule. We are publishing the 
direct final rule because the rule is noncontroversial, and we do not 
anticipate that it will receive any significant adverse comments.
    An 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. 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 rule change in addition to 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 
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 subjects of 
significant adverse comment.
    If no significant adverse comment is received in response to the 
direct final rule, no further action will be taken related to this 
proposed rule. Instead, we will publish a confirmation document, before 
the effective date of the direct final rule, confirming that the direct 
final rule will go into effect on December 21, 2016. In the Federal 
Register of November 21, 1997 (62 FR 62466), you can find additional 
information about direct rulemaking procedures in the guidance document 
entitled ``Guidance for FDA and Industry: Direct Final Rule 
Procedures.'' This guidance may be accessed at http://www.fda.gov/regulatoryinformation/guidances/ucm125166.htm.

III. Purpose and Legal Authority

A. Purpose

    FDA is proposing 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 
proposed rule simply to begin substantively processing the submission. 
FDA expects that this proposed rule would enhance the quality of the 
submissions and that submissions would move expeditiously through the 
review process. In addition, this rule would help submitters better 
understand the common hurdles FDA encounters in conducting a 
substantive review of submissions.
    The proposed rule identifies deficiencies that FDA has seen across 
types of premarket submissions and would result in FDA refusing to 
accept the submission. This proposed 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., 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 would not 
preclude an applicant from resubmitting a new submission that addresses 
the deficiencies. In addition, acceptance of a submission would 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 would begin once 
FDA accepts the submission, and for submissions with filing 
requirements (i.e., PMTAs and MRPTAs), once filed. This proposed rule 
would establish 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 would be refused before 
FDA begins substantive review, we would 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 
the authority to issue regulations for the efficient enforcement of the 
FD&C Act. This proposed rule would 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 proposed rule have 
been repeatedly identified by FDA as reflecting submissions that are 
incomplete and not prepared for further review.

IV. Description of Proposed Regulation

    We are proposing to add part 1105 (21 CFR part 1105) to title 21, 
specifically Sec.  1105.10. Proposed Sec.  1105.10(a) would provide 
that FDA would 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.
     Proposed Sec.  1105.10(a)(1) states that FDA would refuse 
to accept a submission that does not pertain to a tobacco product. This 
provision would

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address 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, would not be subject to FDA's 
tobacco product authorities.
     Proposed Sec.  1105.10(a)(2) states that FDA would 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.
     Proposed Sec.  1105.10(a)(3) provides that FDA would 
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 a submission. FDA provides 
information on the electronic formats that it can read, process, 
review, and archive at http://www.fda.gov/tobaccoproducts/guidancecomplianceregulatoryinformation/manufacturing/default.htm.
     Proposed Sec.  1105.10(a)(4) provides that FDA would 
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 would 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 would 
likely be unable to provide notice of the Agency's refusal to accept 
the submission under Sec.  1105.10(c).
     Proposed Sec.  1105.10(a)(5) provides that FDA would 
refuse to accept a submission from a foreign applicant if it does not 
list an authorized U.S. agent for the submission, including the agent's 
U.S. address. FDA is proposing to require 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 would 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 would act as a communications link 
between FDA and the applicant and would 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 would be authorized to act on behalf of the 
foreign applicant for that specific application.
     Proposed Sec.  1105.10(a)(6) provides that FDA would 
refuse to accept the submission if it does not include any required FDA 
form(s). At the time of this proposed 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).
     Proposed Sec.  1105.10(a)(7) provides that FDA would 
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 Products Categories and Subcategories
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           Tobacco product category                               Tobacco product subcategory
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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.

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                                               Loose Snus.
                                               Portioned Snus.
                                               Loose Dry Snuff.
                                               Dissolvable.
                                               Loose Chewing Tobacco.
                                               Portioned Chewing Tobacco.
                                               Smokeless Co-Package.
                                               Other.
ENDS (Electronic Nicotine Delivery System)...  Open E-Liquid.
                                               Closed E-Liquid.
                                               Closed E-Cigarette.
                                               Open E-Cigarette.
                                               ENDS Component.
                                               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.
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    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 would 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 would 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.)
     Proposed Sec.  1105.10(a)(8) provides that FDA would 
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.
     Proposed Sec.  1105.10(a)(9) provides that FDA would 
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.
     Proposed Sec.  1105.10(a)(10) would apply only to PMTAs, 
MRTPAs, SE applications, and exemption requests (this subsection does 
not apply to the subsequent abbreviated report). For these submissions, 
this proposed paragraph provides that FDA would refuse to accept the 
submission if it does not include an environmental assessment (EA) or a 
valid claim of categorical exclusion prepared in accordance with 21 CFR 
25.40. Under Sec.  25.15(a) (21 CFR 25.15), 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 
would not be 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.
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    \2\ The PMTA and MRTPA pathways, by contrast, have a filing 
stage.
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    Proposed Sec.  1105.10(b) provides that if FDA does not identify a 
reason under paragraph (a) for refusing to accept a premarket review 
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 would 
also include a premarket submission tracking number.
    Proposed Sec.  1105.10(c) provides that if FDA identifies a reason 
under paragraph (a) for refusing to accept a premarket review 
submission, we would notify the applicant in writing of the reason(s) 
and that FDA has not accepted the submission for processing and further 
review. However, FDA would not be able to provide this information when

[[Page 52376]]

the contact information has not been provided or is not legible. If FDA 
would refuse 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. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed 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.

VI. Federalism

    We have analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. We have determined that 
the proposed 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.

VII. Tribal Consultation

    We have analyzed this proposed 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.

VIII. 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.

IX. Economic Analysis of Impacts

    We have examined the impacts of the proposed 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 proposed 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 proposed rule would establish a procedure that 
FDA would be responsible for implementing and would have the effect of 
providing all entities useful feedback on the readiness of a 
submission, we certify that the proposed 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 proposed rule would 
not result in expenditure in any year that meets or exceeds this 
amount.
    This proposed 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 proposed rule would clarify these expectations. This clarification 
would 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 would have clarity about basic 
expectations of the requirements needed for acceptance of premarket 
applications. In addition, refusing to accept submissions with these 
deficiencies would 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.

    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 proposed to be amended by adding part 1105.

PART 1105--GENERAL

Sec.
1105.10 Refusal to accept a premarket 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 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.

[[Page 52377]]

    (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.

    Dated: August 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-18533 Filed 8-5-16; 8:45 am]
 BILLING CODE 4164-01-P


