Refuse To Accept Procedures for Premarket Tobacco Product Submissions, 52371-52377 [2016-18533]
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Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Proposed Rules
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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 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–F–1253 for ‘‘Breast Cancer Fund,
Center for Environmental Health, Center
for Food Safety, Center for Science in
the Public Interest, Clean Water Action,
Consumer Federation of America,
Earthjustice, Environmental Defense
Fund, Improving Kids’ Environment,
Learning Disabilities Association of
America, and Natural Resources Defense
Council; Filing of Food Additive
Petition.’’ 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
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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:
Kelly Randolph, Center for Food Safety
and Applied Nutrition (HFS–265), Food
and Drug Administration, 5001 Campus
Dr., College Park, MD 20740–3835, 240–
402–1188.
SUPPLEMENTARY INFORMATION: In the
Federal Register of May 20, 2016 (81 FR
31877), FDA published a notice of filing
of a food additive petition (FAP 6B4815)
submitted by the Breast Cancer Fund,
Center for Environmental Health, Center
for Food Safety, Center for Science in
the Public Interest, Clean Water Action,
Consumer Federation of America,
Earthjustice, Environmental Defense
Fund, Improving Kids’ Environment,
Learning Disabilities Association of
America, and Natural Resources Defense
Council, c/o Mr. Thomas Neltner, 1875
Connecticut Ave. NW., Suite 600,
Washington, DC 20009. The notice
invited comments on the petition. The
petition proposes that we amend and/or
revoke specified regulations to no longer
provide for the food contact use of
specified ortho-phthalates. Specifically,
the petitioners request that we consider
that ortho-phthalates are a class of
chemically and pharmacologically
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related substances, and state that there
is no longer a reasonable certainty of no
harm for the food contact uses of the
specified ortho-phthalates. If we
determine that new data are available
that justify amending the specified food
additive regulations in 21 CFR parts
175, 176, 177, and 178 so that they will
no longer provide for the use of the
ortho-phthalates, we will publish such
an amendment of these regulations in
the Federal Register, as set forth in
§ 171.130 and § 171.100 (21 CFR
171.100).
We have received a request for a 60day extension of the comment period for
the petition. The request conveyed
concern that the 60-day comment period
does not allow sufficient time to collect
and provide data and information and
develop a meaningful and thoughtful
response to the assertions set forth in
the petition.
FDA has considered the request;
however, because the request was
submitted too late to allow us to extend
the comment period, we are, instead,
reopening the comment period until
September 19, 2016. We believe that reopening the comment period until that
date allows adequate time for interested
persons to submit comments without
significantly delaying our review.
Dated: August 2, 2016.
Dennis M. Keefe,
Director, Office of Food Additive Safety,
Center for Food Safety and Applied Nutrition.
[FR Doc. 2016–18720 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:
Proposed rule.
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
SUMMARY:
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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: 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
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’’).
ehiers on DSK5VPTVN1PROD with PROPOSALS
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–
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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 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:
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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).
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
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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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.
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 https://
www.fda.gov/regulatoryinformation/
guidances/ucm125166.htm.
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,
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
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III. Purpose and Legal Authority
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(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
§ 1105.10. Proposed § 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 § 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 § 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 § 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 https://www.fda.gov/
tobaccoproducts/guidancecompliance
regulatoryinformation/manufacturing/
default.htm.
• Proposed § 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
§ 1105.10(c).
• Proposed § 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 § 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 § 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
Tobacco product category
Tobacco product subcategory
Cigarettes ...................................................................................................................................................
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Roll-Your-Own Tobacco Products ..............................................................................................................
Smokeless Tobacco Products ....................................................................................................................
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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.
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TABLE 1—TOBACCO PRODUCTS CATEGORIES AND SUBCATEGORIES—Continued
Tobacco product category
Tobacco product subcategory
ENDS (Electronic Nicotine Delivery System) .............................................................................................
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 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 § 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.
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• Proposed § 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 § 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
§ 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, § 25.15(a) provides that
FDA may refuse to file a submission if
PO 00000
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Fmt 4702
Sfmt 4702
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.
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.
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.
Proposed § 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 § 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
2 The PMTA and MRTPA pathways, by contrast,
have a filing stage.
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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
§ 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.
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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
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Jkt 238001
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
PO 00000
Frm 00008
Fmt 4702
Sfmt 4702
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
§ 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.
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Federal Register / Vol. 81, No. 152 / Monday, August 8, 2016 / Proposed Rules
(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
DEPARTMENT OF JUSTICE
Office of Justice Programs
28 CFR Part 31
[Docket No.: OJP (OJJDP) 1719]
RIN 1121–AA83
Juvenile Justice and Delinquency
Prevention Act Formula Grant Program
Office of Justice Programs,
Justice.
ACTION: Notice of proposed rulemaking.
AGENCY:
The Office of Justice Programs
(‘‘OJP’’) proposes to update the
implementing regulation for the
Formula Grant Program authorized by
Title II, Part B, of the Juvenile Justice
and Delinquency Prevention Act of 1974
(‘‘the Act’’ or ‘‘JJDPA’’). The purpose of
the Formula Grant Program is to provide
formula grant awards to states to
support juvenile delinquency
ehiers on DSK5VPTVN1PROD with PROPOSALS
SUMMARY:
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prevention programs and to improve
their juvenile justice systems. The
proposed rule would supersede the
existing Formula Grant Program
regulations to reflect changes in the
2002 JJDPA reauthorization as well as
policy changes to the Formula Grant
Program.
DATES: Comments must be received by
no later than 11:59 p.m., E.T., on
October 7, 2016.
ADDRESSES: You may view an electronic
version of this proposed rule at https://
www.regulations.gov, and you may also
comment by using the
www.regulations.gov form for this
regulation. OJP welcomes comments
from the public on this proposed rule
and prefers to receive comments via
www.regulations.gov when possible.
When submitting comments
electronically, you should include OJP
Docket No. 1719 in the subject box.
Additionally, comments may also be
submitted via U.S. mail, to: Mr. Gregory
Thompson, Senior Advisor, Office of
Juvenile Justice and Delinquency
Prevention, Office of Justice Programs,
U.S. Department of Justice, 810 7th
Street NW., Washington, DC 20531. To
ensure proper handling, please
reference OJP Docket No. 1719 on your
correspondence.
FOR FURTHER INFORMATION CONTACT: Mr.
Gregory Thompson, Senior Advisor,
Office of Juvenile Justice and
Delinquency Prevention, at 202–307–
5911.
SUPPLEMENTARY INFORMATION:
I. Posting of Public Comments
Please note that all comments
received are considered part of the
public record and made available for
public inspection online at https://
www.regulations.gov. Such information
includes personal identifying
information (such as your name,
address, etc.) voluntarily submitted by
the commenter.
If you wish to submit personal
identifying information (such as your
name, address, etc.) as part of your
comment, but do not wish for it to be
posted online, you must include the
phrase ‘‘PERSONAL IDENTIFYING
INFORMATION’’ in the first paragraph
of your comment. You must also locate
all the personal identifying information
you do not want posted online in the
first paragraph of your comment and
identify what information you want
redacted.
If you wish to submit confidential
business information as part of your
comment but do not wish it to be posted
online, you must include the phrase
‘‘CONFIDENTIAL BUSINESS
PO 00000
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Fmt 4702
Sfmt 4702
52377
INFORMATION’’ in the first paragraph
of your comment. You must also
prominently identify confidential
business information to be redacted
within the comment. If a comment has
so much confidential business
information that it cannot be effectively
redacted, all or part of that comment
may not be posted on https://
www.regulations.gov.
Personal identifying information
identified and located as set forth above
will be placed in the agency’s public
docket file, but not posted online.
Confidential business information
identified and located as set forth above
will not be placed in the agency’s public
docket file, nor will it be posted online.
If you wish to inspect the agency’s
public docket file in person by
appointment, please see the ‘‘FOR
FURTHER INFORMATION CONTACT’’
paragraph.
II. Executive Summary
A. Purpose of the Proposed Regulatory
Action
Title II, Part B, of the JJDPA
authorizes the Administrator of the
Office of Juvenile Justice and
Delinquency Prevention (OJJDP) to
make formula grant awards to
participating states to assist them in
planning, establishing, operating,
coordinating, and evaluating projects
directly or through grants and contracts
with public and private agencies for the
development of more effective
education, training, research,
prevention, diversion, treatment, and
rehabilitation programs in the area of
juvenile delinquency and programs to
improve the juvenile justice system. OJP
proposes this rule pursuant to the
rulemaking authority granted to the
Administrator under 42 U.S.C. 5611.
The proposed rule would codify and
update the existing regulation
promulgated at 60 FR 21852 on May 31,
1995, and amended at 61 FR 65132 on
December 10, 1996 (the ‘‘current
regulation’’), to reflect statutory changes
included in the 2002 reauthorization of
the JJDPA as well as changes in OJP
policy regarding administration of the
commonly-named Part B Formula Grant
Program (Formula Grant Program).
B. Summary of the Major Provisions of
the Proposed Regulatory Action
As discussed more fully in section IV,
below, the proposed rule contains the
following major provisions that differ
from the current regulation: (1)
Establishing new substantial
compliance standards in place of the
current de minimis standards for
determining states’ compliance with the
E:\FR\FM\08AUP1.SGM
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Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: 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 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
Product 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 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).
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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 https://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
[[Page 52374]]
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 https://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
----------------------------------------------------------------------------------------------------------------
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.
[[Page 52375]]
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.
----------------------------------------------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\2\ The PMTA and MRTPA pathways, by contrast, have a filing
stage.
---------------------------------------------------------------------------
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]
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