Refuse To Accept Procedures for Premarket Tobacco Product Submissions, 52329-52335 [2016-18534]
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Federal Register of May 4, 2016 (81 FR
26687), FDA solicited comments
concerning the direct final rule for a 75day period ending July 18, 2016. FDA
stated that the effective date of the
direct final rule would be on September
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comment period, unless any significant
adverse comment was submitted to FDA
during the comment period. FDA did
not receive any significant adverse
comments.
[FR Doc. 2016–18070 Filed 8–5–16; 8:45 am]
BILLING CODE 3510–33–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 610
[Docket No. FDA–2016–N–1170]
Standard Preparations, Limits of
Potency, and Dating Period Limitations
for Biological Products; Confirmation
of Effective Date
AGENCY:
Food and Drug Administration,
HHS.
Direct final rule; confirmation of
effective date.
ACTION:
The Food and Drug
Administration (FDA) is confirming the
effective date of September 16, 2016, for
the final rule that appeared in the
Federal Register of May 4, 2016. The
direct final rule amends the general
biological products standards relating to
dating periods and removes certain
standards relating to standard
preparations and limits of potency. FDA
is taking this action to update outdated
requirements, and accommodate new
and evolving technology and testing
capabilities without diminishing public
health concerns. This action is part of
FDA’s retrospective review of its
regulations in response to an Executive
order. This document confirms the
effective date of the direct final rule.
DATES: Effective date of final rule
published in the Federal Register of
May 4, 2016 (81 FR 26687), confirmed:
September 16, 2016.
FOR FURTHER INFORMATION CONTACT:
Tami Belouin, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
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SUMMARY:
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Authority: Therefore, under the biological
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and 264) and the drugs and general
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Food, Drug, and Cosmetic Act (21 U.S.C. 321,
331, 351, 352, 353, 355, 360, 360c, 360d,
360h, 360i, 371, 372, 374, and 381), and
under authority delegated to the
Commissioner of Food and Drugs, 21 CFR
part 610 is amended. Accordingly, the
amendments issued thereby are effective.
Dated: August 1, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–18584 Filed 8–5–16; 8:45 am]
BILLING CODE 4164–01–P
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.
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
SUMMARY:
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License
Exception
§ 740.11(b)(2)(ii) only.
GOV
under
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: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
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
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identifies you in the body of your
comments, that information will be
posted on https://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
https://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 https://
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
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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: https://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
https://www.regulations.gov and insert
the docket number, found in brackets in
the heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the 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 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
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.
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requests (including subsequent
abbreviated reports).
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 https://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
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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
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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
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52331
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 § 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 https://
www.fda.gov/tobaccoproducts/
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• 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
§ 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 .................................................................................................
Roll-Your-Own Tobacco Products ............................................................
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Smokeless Tobacco Products ..................................................................
ENDS (Electronic Nicotine Delivery System) ...........................................
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Combusted, Filtered.
Combusted, Non-Filtered.
Combusted, Other.
Non-Combusted.
Roll-Your-Own Tobacco Filler.
Rolling Paper.
Filtered Cigarette Tube.
Non-Filtered Cigarette Tube.
Filter.
Paper Tip.
Roll-Your-Own Co-Package.
Other.
Loose Moist Snuff.
Portioned Moist Snuff.
Loose Snus.
Portioned Snus
Loose Dry Snuff.
Dissolvable.
Loose Chewing Tobacco.
Portioned Chewing Tobacco.
Smokeless Co-Package.
Other.
Open E-Liquid.
Closed E-Liquid.
Closed E-Cigarette.
Open E-Cigarette.
ENDS Component.
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TABLE 1—TOBACCO PRODUCT CATEGORIES AND SUBCATEGORIES—Continued
Tobacco product category
Tobacco product subcategory
Cigars .......................................................................................................
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Pipe Tobacco Products ............................................................................
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.
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ENDS Co-Package.
ENDS Other.
Filtered, Sheet-Wrapped Cigar.
Unfiltered, Sheet-Wrapped Cigar.
Leaf-Wrapped Cigar.
Cigar Component.
Cigar Tobacco Filler.
Cigar Co-Package.
Other.
Pipe.
Pipe Tobacco Filler.
Pipe Component.
Pipe Co-Package.
Other.
• 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 § 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, § 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 § 25.40.
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.
2 The PMTA and MRTPA pathways, by contrast,
have a filing stage.
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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 § 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.
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52334
Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Rules and Regulations
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.
rmajette on DSK2TPTVN1PROD with RULES
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
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13:12 Aug 05, 2016
Jkt 238001
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
§ 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;
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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.
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Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Rules and Regulations
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
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 117
[Docket No. USCG–2016–0747]
Drawbridge Operation Regulation;
Umpqua River, Reedsport, OR
Coast Guard, DHS.
Notice of deviation from
drawbridge regulations.
AGENCY:
ACTION:
The Coast Guard has issued a
temporary deviation from the operating
schedule that governs the US 101 Bridge
across the Umpqua River, mile 11.1, at
Reedsport, OR. The deviation is
necessary to accommodate updating the
electric control panels on the bridge.
This deviation allows the US 101 Bridge
to remain in the closed-to-navigation
position during upgrades.
DATES: This deviation is effective from
7 a.m. on August 16, 2016 until 5 p.m.
on August 18, 2016.
ADDRESSES: The docket for this
deviation, [USCG–2016–0747] is
available at https://www.regulations.gov.
Type the docket number in the
‘‘SEARCH’’ box and click ‘‘SEARCH.’’
Click on Open Docket Folder on the line
associated with this deviation.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this temporary
deviation, call or email Mr. Steven
Fischer, Bridge Administrator,
Thirteenth Coast Guard District;
telephone 206–220–7282, email d13-pfd13bridges@uscg.mil.
SUPPLEMENTARY INFORMATION: The
Oregon Department of Transportation
requested that the US 101 Bridge, near
Reedsport, Oregon, remain in the
closed-to-navigation position to update
the electric control panels. The US 101
Bridge crosses the Umpqua River at mile
11.1 and provides 36 feet of vertical
clearance above mean high water when
in the closed-to-navigation position.
This deviation allows the US 101 Bridge
to remain in the closed-to-navigation
position and need not open for maritime
traffic from 7 a.m. on August 16, 2016
until 5 p.m. August 18, 2016. The
normal operating schedule of this bridge
is detailed at 33 CFR 117.893(a).
Waterway usage on this part of the
Umpqua River includes vessels ranging
rmajette on DSK2TPTVN1PROD with RULES
SUMMARY:
VerDate Sep<11>2014
13:12 Aug 05, 2016
Jkt 238001
from occasional commercial tug and
barge to small pleasure craft. ODOT has
coordinated with local mariners in this
regard, and no objections have been
received. No immediate alternate route
is available for vessels to pass. The
Coast Guard will also inform the users
of the waterways through our Local and
Broadcast Notices to Mariners of the
change in operating schedule for the
bridge so that vessels can arrange their
transits to minimize any impact caused
by the temporary deviation. Vessels
which do not require an opening of the
bridge may continue to transit beneath
the bridge during this repair period.
In accordance with 33 CFR 117.35(e),
the drawbridge must return to its regular
operating schedule immediately at the
end of the designated time period. This
deviation from the operating regulations
is authorized under 33 CFR 117.35.
Dated: July 29, 2016.
Steven M. Fischer,
Bridge Administrator, Thirteenth Coast Guard
District.
[FR Doc. 2016–18709 Filed 8–5–16; 8:45 am]
BILLING CODE 9110–04–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[Docket Number USCG–2016–0670]
RIN 165–AA00
Safety Zones; Marine Events Held in
the Sector Long Island Sound Captain
of the Port Zone
Coast Guard, DHS.
Temporary final rule.
AGENCY:
ACTION:
The Coast Guard is
establishing nine temporary safety zones
for fireworks displays within the Coast
Guard Sector Long Island Sound (LIS)
Captain of the Port (COTP) Zone. This
temporary final rule is necessary to
provide for the safety of life on
navigable waters during these events.
Entry into, transit through, mooring or
anchoring within these regulated areas
is prohibited unless authorized by
COTP Sector Long Island Sound.
DATES: This rule is effective without
actual notice from August 8, 2016
through September 03, 2016. For the
purposes of enforcement, actual notice
will be used July 30, 2016, through
August 8, 2016.
ADDRESSES: To view documents
mentioned in this preamble as being
available in the docket, go to https://
www.regulations.gov, type USCG–2016–
SUMMARY:
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52335
0670 in the ‘‘SEARCH’’ box and click
‘‘SEARCH.’’ Click on Open Docket
Folder on the line associated with this
rule.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this rule, contact
Petty Officer Jay TerVeen, Prevention
Department, Coast Guard Sector Long
Island Sound, telephone (203) 468–
4446, email Jay.C.TerVeen@uscg.mil.
SUPPLEMENTARY INFORMATION:
I. Table of Abbreviations
COTP Captain of the Port
DHS Department of Homeland Security
FR Federal Register
LIS Long Island Sound
NPRM Notice of Proposed Rulemaking
NAD 83 North American Datum 1983
II. Background Information and
Regulatory History
This rulemaking establishes 9 safety
zones for fireworks displays. Each event
and its corresponding regulatory history
are discussed below.
The Hoffman Wedding Fireworks
Display is a first time marine event with
no regulatory history.
The Pyro Engineering Inc. Fireworks
Display is a first time marine event with
no regulatory history.
The Sag Harbor Fire Department
Fireworks Display is a recurring marine
event with regulatory history. A safety
zone was established for this event in
2015 via a temporary final rule entitled,
‘‘Safety Zones; Marine Events held in
the Sector Long Island Sound Captain of
the Port Zone.’’ This rulemaking was
published on Friday, August 14, 2015 in
the Federal Register (80 FR 48692).
The Montalbano Wedding Fireworks
Display is a first time marine event with
no regulatory history.
The Village of Saltaire Fireworks
Display is a recurring marine event with
regulatory history. A safety zone was
established for this event in 2015 via a
temporary final rule entitled, ‘‘Special
Local Regulations and Safety Zones;
Marine Events held in the Sector Long
Island Sound Captain of the Port Zone.’’
This rulemaking was published on
Monday, May 18, 2015 in the Federal
Register (80 FR 28176).
The Baker Annual Summer
Celebration is a first time marine event
with no regulatory history.
The Gestal Wedding Fireworks
Display is a first time marine event with
no regulatory history.
The Clinton Chamber of Commerce
Fireworks Display is a recurring marine
event with regulatory history. A safety
zone was established for this event in
2015 via a temporary final rule entitled,
‘‘Safety Zones; Marine Events held in
the Sector Long Island Sound Captain of
E:\FR\FM\08AUR1.SGM
08AUR1
Agencies
[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: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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 https://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 https://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: https://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 https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the 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 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 https://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 https://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