submitting an application that meets the content requirements of Sec.
1114.7 or 1114.15 (if applicable), submit a resubmission to address
deficiencies set forth in a marketing denial order. The resubmission
must contain new information necessary to address application
deficiencies and cross-reference applicable content from the PMTA that
received the marketing denial order. An applicant may utilize the
resubmission format for the same tobacco product for which FDA issued a
marketing denial order or a new tobacco product that results from
modifications to the product necessary to address the deficiencies
described in a marketing denial order. An applicant may not submit a
resubmission when:
    (1) It incorporates new information or revisions to the PMTA for
the original product to the extent that reviewing a resubmission for
the new tobacco product would be confusing, cumbersome, or otherwise
inefficient and submitting a standard PMTA under Sec.  1114.7 would
better facilitate review; or
    (2) The marketing denial order states that the applicant may not
submit a resubmission.

    (b) Required format. The resubmission must comply with format
requirements of Sec.  1114.7(b), except that an applicant must include
content in the resubmission by cross-referencing the PMTA, or, where
applicable, supplemental PMTA, that received the marketing denial
order. An applicant may also include content in a resubmission by
cross-reference to a TPMF. FDA will not consider content included by
cross-reference to other sources of information outside of the
submission.
    (c) Required content. The resubmission must provide sufficient
information for FDA to determine whether any of the grounds for denial
listed in section 910(c)(2) of the Federal Food, Drug, and Cosmetic Act
apply to the application.
    (1) The application must include the full text of the information
described in the following paragraphs:
    (i) General information that identifies the submission as a
resubmission (as described in paragraph Sec.  1114.7(c));
    (ii) Response to deficiencies (as described in paragraph (d) of
this section); and
    (iii) Certification statement (as described in paragraph (e) of
this section).
    (2) The application must include the following sections from the
PMTA that received a marketing denial order by cross-reference to the
PMTA and contain all additional information, in full text or by
reference to a tobacco product master file, that is necessary to
supplement or update the cross-referenced information:
    (i) Descriptive information (as described in Sec.  1114.7(d));
    (ii) Product samples (as described in Sec.  1114.7(e));
    (iii) Labeling (as described in Sec.  1114.7(f));
    (iv) Statement of compliance with 21 CFR part 25 (as described in
Sec.  1114.7(g));
    (v) Summary of all research findings (as described in Sec.
1114.7(h));
    (vi) Product formulation (as described in Sec.  1114.7(i));
    (vii) Manufacturing (as described in Sec.  1114.7(j)); and
    (viii) Health risk investigations (as described in Sec.
1114.7(k)).
    (d) Response to deficiencies. (1) The application must include a
section that lists and provides a separate response to each deficiency
described by FDA in the original marketing denial order, including all
data and information necessary to complete each response, and that also
addresses any applicant-identified deficiencies.
    (2) Where an applicant modifies the product in a way that would
result in a new tobacco product under section 910(a)(1) of the Federal
Food, Drug, and Cosmetic Act in order to address the deficiencies, the
application must also include:
    (i) A full description of each modification to the product and
comparisons of that change to the original version of the product
described in the previously submitted PMTA; and
    (ii) All data and information relating to each modification to the
product that would be required in an application under Sec.  1114.7.
    (e) Certification statement. The application must contain one of
the two following certifications that corresponds to the application,
with the appropriate information inserted as indicated by parenthetical
italicized text, signed by an authorized representative of the
applicant.
    (1) Same tobacco product certification. An application for the same
tobacco product must contain the following certification:

    ``I, (name of responsible official), on behalf of (name of
applicant), certify that this submission for (new tobacco product
name(s)) responds to all deficiencies outlined in the marketing
denial order issued in response to (STN of the previously submitted
PMTA) and the new tobacco product described herein is identical to
the product described in the previously submitted PMTA. I certify
that (name of applicant) understands this means there is no
modification to the materials, ingredients, design, composition,
heating source, or any other feature. I also certify that (name of
applicant) will maintain all records that substantiate the accuracy
of this statement, and ensure that such records remain readily
available to FDA upon request for the period of time required in 21
CFR 1114.45. I certify that this information and the accompanying
submission are true and correct, and that I am authorized to submit
this on the company's behalf. I understand that under section 1001
of title 18 of the United States Code, anyone who knowingly and
willfully makes a materially false, fictitious, or fraudulent
statement or representation in any matter within the jurisdiction of
the executive, legislative, or judicial branch of the Government of
the United States is subject to criminal penalties.''

    (2) Different tobacco product certification. An application for a
different tobacco product than the original tobacco product that
results from changes necessary to address the deficiencies must contain
the following certification:

    ``I, (name of responsible official), on behalf of (name of
applicant), certify that this submission for (new tobacco product
name(s)) responds to all deficiencies outlined in the marketing
denial order issued in response to (STN of the previously submitted
PMTA) and the new tobacco product described herein has a different
(describe each modification to the product) than (name(s) of
original tobacco product) described in (STN of the previously
submitted PMTA) but is otherwise identical to (name(s) of original
tobacco product) described in (STN of the previously submitted
PMTA). I certify that (name of applicant) understands this means
there is no modification to the materials, ingredients, design
features, heating source, or any other feature of the original
tobacco product, except for the (describe each modification to the
tobacco product). I also certify that (name of applicant) will
maintain all records that substantiate the accuracy of this
statement, and ensure that such records remain readily available to
FDA upon request for the period of time required in 21 CFR 1114.45.
I certify that this information and the accompanying submission are
true and correct, and that I am authorized to submit this on the
company's behalf. I understand that under section 1001 of title 18
of the United States Code, anyone who knowingly and willfully makes
a materially false, fictitious, or fraudulent statement or
representation in any matter within the jurisdiction of the
executive, legislative, or judicial branch of the Government of the
United States is subject to criminal penalties.''

Subpart C--FDA Review

Sec.  1114.25   Communication between FDA and applicants.

    During the course of reviewing an application, FDA may communicate
with an applicant about relevant matters, including scientific,
medical, and procedural issues that arise during the review process and
inspections. These communications may take the form of telephone
conversations, letters, electronic communications, or meetings, and
will be documented in the administrative file in accordance with Sec.
10.65 of this chapter.

Sec.  1114.27  Review procedure.

    (a) Acceptance review. (1) After an applicant submits a PMTA, FDA
will perform an initial review of the PMTA to determine whether it may
be accepted for further review. FDA may refuse to accept an application
that:
    (i) Does not comply with the applicable format requirements in
Sec.  1114.7(b), Sec.  1114.15, or Sec.  1114.17 (as applicable);
    (ii) Is not administratively complete because it does not appear to
contain the information required by Sec.  1114.7 (excluding product
samples), Sec.  1114.15 or Sec.  1114.17, as applicable;
    (iii) Does not pertain to a tobacco product subject to chapter IX
of the Federal Food, Drug, and Cosmetic Act (as required by Sec.
1105.10 of this chapter); or
    (iv) FDA can otherwise refuse to accept under Sec.  1105.10.

    (2) If FDA accepts an application for further review, FDA will
issue an acknowledgement letter to the applicant that specifies the
PMTA STN. If FDA determines that it will require product samples as
part of the PMTA, it will send instructions on how and where to submit
product samples, as described in Sec.  1114.7(e) of this chapter.
    (3) If FDA refuses to accept an application, FDA will issue a
letter to the applicant identifying the deficiencies, where
practicable, that prevented FDA from accepting the application.
    (b) Filing review. (1) After accepting a PMTA, FDA will make a
threshold determination of whether the application contains sufficient
information to permit a substantive review. FDA may refuse to file a
PMTA if any of the following applies:
    (i) The PMTA does not contain sufficient information required by
section 910(b)(1) of the Federal Food, Drug, and Cosmetic Act and by
Sec.  1114.7, Sec.  1114.15, or Sec.  1114.17, as applicable, to permit
a substantive review of the application;
    (ii) The application does not contain any substantive information,
including information from published literature or bridged from an
investigation of another tobacco product, regarding each of the
following topics.
    (A) The health risks of the new tobacco product as described in
either Sec.  1114.7(k)(1)(i)(A), (B), or (C));
    (B) The health risks of the new tobacco product compared to the
health risks generally presented by products in the same product
category as well as products in at least one different category that
are used by the consumers an applicant expects will use its new tobacco
product (as described in a portion of Sec.  1114.7(k)(1)(i)(D)).
    (C) The abuse liability of the new tobacco product (as set forth in
Sec.  1114.7(k)(1)(ii)(A));
    (D) How consumers would be expected to actually use the product,
such as use frequency, use trends over time, and how such use affects
the health risks of the product to individual users (as described in
Sec.  1114.7(k)(1)(ii)(B));
    (E) The potential impact that the marketing of the new tobacco
product would have on the likelihood that current tobacco product users
would change their tobacco product use behavior, such as starting to
using the new tobacco product, using the product in conjunction with
other tobacco products, or, after using the product, switching to or
switch back to other tobacco products that may present increased risks
to individual health (i.e., any of the information set forth in either
Sec.  1114.7(k)(1)(ii)(C), (D), (E), or (F));
    (F) The impact of the tobacco product and its label, labeling, or
advertising, to the extent that advertising has been studied, on
tobacco product use behavior of current nonusers of tobacco products
(i.e., any of the information described in Sec.  1114.7(k)(1)(iii));
    (G) The impact of the product and its label, labeling, or
advertising, to the extent that advertising has been studied, on
individuals' perception of the product and their use intentions (i.e.,
any of the information described in Sec.  1114.7(k)(1)(iv)); and
    (H) The ways in which human factors can affect the health risks of
the new tobacco product (i.e., any of the information described in
Sec.  1114.7(k)(1)(v));
    (iii) The PMTA contains a false statement of material fact;
    (iv) The PMTA is a supplemental PMTA that does not comply with
Sec.  1114.15; or
    (v) The PMTA is a resubmission that does not comply with Sec.
1114.17.
    (2) If FDA refuses to file an application, FDA will issue a letter
to the applicant identifying the deficiencies, where practicable, that
prevented FDA from filing the application.
    (3) If FDA files an application, FDA will issue a filing letter to
the applicant.
    (c) Application review. (1) Except as described in this paragraph
and Sec.  1114.9(b), within 180 days of receipt of an application
described in section 910(b)(1) of the Federal Food, Drug, and Cosmetic
Act meeting the filing requirements set out in 1114.27(b), FDA will
complete its review of the PMTA and act on the application.
    (2) FDA will begin substantive review of the application after it
is filed under paragraph (b) of this section. FDA may communicate with
the applicant as set forth under Sec.  1114.25 to seek additional or
clarifying information.
    (3) FDA may refer the PMTA or portions of the PMTA, upon its own
initiative or applicant request, to TPSAC for reference and for the
submission of a report and recommendation respecting the application,
together with all underlying data and the reasons or basis for the
recommendation.
    (4) FDA may conduct inspections of the applicant's manufacturing
sites, and sites and entities involved with clinical and nonclinical
research (including third parties and contract research organizations)
to support FDA's review of the PMTA. Where an applicant prevents FDA
from scheduling and conducting inspections that are necessary for FDA
to complete its review of the PMTA in a timely manner, FDA may pause
the 180-day review period for the number of days necessary to complete
the inspection.
    (5) FDA may defer review of a PMTA for a new product that, if
introduced or delivered for introduction into interstate commerce,
would be adulterated or misbranded due to the manufacturer or
importer's failure to comply with user fee payment and reporting
requirements under part 1150.

Sec.  1114.29  FDA action on an application.

    After receipt of an application, FDA will:
    (a) Refuse to accept the application as described in Sec.
1114.27(a);
    (b) Issue a letter administratively closing the application;
    (c) Issue a letter canceling the application if FDA finds that it
mistakenly accepted the application or that the application was
submitted in error;
    (d) Refuse to file the application as described in Sec.
1114.27(b);
    (e) Issue a marketing granted order as described in Sec.  1114.31;
or
    (f) Issue a marketing denial order as described in Sec.  1114.33.

Sec.  1114.31  Issuance of a marketing granted order.

    (a) FDA will issue a marketing granted order if it finds that none
of the grounds for denial listed in section 910(c)(2) of the Federal
Food, Drug, and Cosmetic Act apply. A marketing granted order becomes
effective on the date it is issued.
    (b) FDA may include, as part of the marketing granted order:
    (1) Restrictions on the sale and distribution of the product,
including restrictions on the access to, and the advertising and
promotion of, the tobacco product, to the extent that it would be
authorized to impose such restrictions under a regulation issued under
section 906(d) of the Federal Food, Drug, and Cosmetic Act;
    (2) Any restrictions on the sales, distribution, advertising, and
promotion of the new tobacco product that the applicant proposed to be
included as part of a marketing granted order under section
910(c)(1)(B) of the Federal Food, Drug, and Cosmetic Act to support a
finding by FDA that permitting the product to be marketed would be
appropriate for the protection of the public health; and
    (3) Requirements to establish and maintain records, and submit
postmarket reports under section 910(f) of the Federal Food, Drug and
Cosmetic Act in addition to those described in Sec.  1114.41, including
but not limited to

information such as labeling, advertising, marketing, promotional
materials, or marketing plans not previously submitted to FDA.

Sec.  1114.33  Issuance of a marketing denial order.

    (a) Issuance. FDA will issue a marketing denial order if:
    (1) Upon the basis of the information submitted as part of the
application and any other information before FDA with respect to the
new tobacco product, FDA finds that any of the grounds for denial
listed in section 910(c)(2) of the Federal Food, Drug, and Cosmetic Act
apply;
    (2) The applicant does not permit an authorized FDA employee, at a
reasonable time and in a reasonable manner, an opportunity to:
    (i) Inspect the facilities and controls described in the
application; or
    (ii) Have access to, copy, and verify all records pertinent to the
application, which results in FDA finding that one or more of the
grounds for denial specified in section 910(c)(2) of the Federal Food,
Drug and Cosmetic Act apply.
    (b) Description of deficiencies. The marketing denial order will,
where practicable, identify measures to remove the application from
deniable form.

Sec.  1114.35  Withdrawal of a marketing granted order.

    (a) Grounds for withdrawal. FDA will withdraw a marketing granted
order for a new tobacco product issued under this part if FDA
determines that:
    (1) Any of the grounds for withdrawal under section 910(d)(1) of
the Federal Food, Drug, and Cosmetic Act apply; or
    (2) Any postmarket requirement imposed by the marketing granted
order or by this part has not been met, which results in FDA finding
that one or more of the grounds for withdrawal specified in section
910(d)(1) of the Federal Food, Drug and Cosmetic Act apply.
    (b) Advice and other information. (1) FDA may seek advice on
scientific matters from any appropriate FDA advisory committee in
deciding whether to withdraw a marketing granted order.
    (2) FDA may use information other than that submitted by the
applicant in deciding whether to withdraw a marketing granted order.
    (c) Informal hearing. Prior to withdrawing a marketing granted
order, FDA will offer the holder of the marketing granted order an
opportunity for an informal hearing under part 16 of this chapter.
    (d) Order issuance. If the applicant does not request a hearing or,
if after the part 16 hearing is held, the Agency decides to proceed
with the withdrawal, FDA will issue to the holder of the marketing
granted order an order withdrawing the marketing granted order for the
new tobacco product.
    (e) Public notice. FDA will give the public notice of an order
withdrawing a marketing granted order for a tobacco product and will
announce the basis of the withdrawal.

Sec.  1114.37  Temporary suspension of a marketing granted order.

    (a) FDA will temporarily suspend a marketing granted order if FDA
determines that there is a reasonable probability that the continued
distribution of such tobacco product would cause serious, adverse
health consequences or death, that is greater than ordinarily caused by
tobacco products on the market.
    (b) Before temporarily suspending a marketing granted order of a
tobacco product, FDA will offer the holder of the marketing granted
order an opportunity for an informal hearing under part 16 of this
chapter.
    (c) If, after offering the holder of the marketing granted order an
opportunity for a part 16 hearing, the Agency decides to proceed with
the temporary suspension, FDA will issue an order temporarily
suspending the marketing granted order for a tobacco product.
    (d) After issuing an order temporarily suspending the marketing
granted order, FDA will proceed expeditiously to withdraw the marketing
granted order for the tobacco product.

Subpart D--Postmarket Requirements

Sec.  1114.39  Postmarket changes.

    A marketing granted order authorizes the marketing of a new tobacco
product in accordance with the terms of the order. Prior to the
introduction or delivery for introduction into interstate commerce of a
new tobacco product that results from modification(s) to the product,
an applicant must submit a new PMTA under Sec.  1114.7 or a
supplemental PMTA under Sec.  1114.15 and obtain a marketing granted
order for the new tobacco product, unless the new tobacco product can
be legally marketed through another premarket pathway.

Sec.  1114.41   Reporting requirements.

    (a) Required reports. Each applicant that receives a marketing
granted order must submit to FDA all information required by the terms
of the marketing granted order and by this section as described below.
Each postmarket report must be well-organized, legible, and written in
English. Documents that have been translated from another language into
English (e.g., original study documents written in a language other
than English) must be accompanied by the original language version of
the document, a signed statement by an authorized representative of the
manufacturer certifying that the English language translation is
complete and accurate, and a brief statement of the qualifications of
the person that made the translation.
    (1) Periodic reports. Each applicant must submit a periodic report
to the Center for Tobacco Products (CTP) within 60 calendar days of the
reporting dates specified in the applicant's marketing granted order
for the life of the order and as may be required for the submission of
a supplemental PMTA under Sec.  1114.15. The report must include the
following:
    (i) A cover letter that contains the PMTA STN, tobacco product
name(s) (including the original name described in the PMTA if
different), company name, date of report, and reporting period;
    (ii) A description of all changes made to the manufacturing,
facilities, or controls during the reporting period, including:
    (A) A comparison of each change to what was described in the PMTA;
    (B) The rationale for making each change and, if any, a listing of
any associated changes; and
    (C) The basis for concluding that each change does not result in a
new tobacco product that is outside the scope of the marketing granted
order and will not result in a finding that the marketing granted order
must be withdrawn or temporarily suspended under section 910(d) of the
Federal Food, Drug, and Cosmetic Act;
    (iii) An inventory of ongoing and completed studies about the
tobacco product conducted by, or on behalf of, the applicant that are
within the scope of Sec.  1114.7(k) and that have not been previously
reported;
    (iv) Full reports of information published or known to, or which
should be reasonably known to, the applicant concerning scientific
investigations and literature about the tobacco product that have not
been previously reported, including significant findings from
publications not previously reported;
    (v) A summary and analysis of all serious and unexpected adverse
experiences associated with the tobacco product that have been reported
to the applicant or that the applicant is aware of, accompanied by a
statement of any changes to the overall risk associated with the
tobacco product, and a summary of any changes in the health

risks, including the nature and frequency of the adverse experience,
and potential risk factors;
    (vi) A summary of sales and distribution of the tobacco product for
the reporting period, to the extent that the applicant collects or
receives such data, including:
    (A) Total U.S. sales reported in dollars, units, and volume with
breakdowns by U.S. census region, major retail markets, and channels in
which the product is sold;
    (B) The Universal Product Code that corresponds to the product(s)
identified in the PMTA; and
    (C) Demographic characteristics of product(s) purchasers, such as
age, gender, race or ethnicity, geographic region, and tobacco use
status;
    (vii) A summary of the implementation and effectiveness of policies
and procedures regarding verification of the age and identity of
purchasers of the product; and
    (viii) A summary of all formative consumer research studies
conducted (if any), among any audiences, in the formation of new
labeling, advertising, marketing, or promotional materials, not
previously submitted, including qualitative and quantitative research
studies used to determine message effectiveness, consumer knowledge,
attitudes, beliefs, intentions and behaviors toward using the products,
and including the findings or these studies and copies of the stimuli
used in testing;
    (xi) A summary of all consumer evaluation research studies
conducted (if any), among any audiences, not previously submitted, to
determine the effectiveness of labeling, advertising, marketing, or
promotional materials and shifts in consumer knowledge, attitudes,
beliefs, intentions, and behaviors toward using the products, and
including the findings of these studies and copies of the stimuli used
in testing;
    (xii) A summary of the creation and dissemination of the products'
labeling, advertising, marketing, and promotional materials (if any),
including a list of all entities involved and a description of their
involvement, including a description of contractual agreements with
such entities;
    (xiii) Specimens of all labeling and descriptions of all labeling
changes that have not been previously submitted under section 905(i) of
the Federal Food, Drug, and Cosmetic Act, including the date the
labeling was first disseminated and the date when dissemination was
completely terminated;
    (xiv) Full color copies of all advertising for the tobacco product
that has not been previously submitted, and the original date the
materials were first disseminated and the date when their dissemination
was completely terminated;
    (xv) A description of the implementation of all advertising and
marketing plans, not previously submitted to FDA, by channel and by
product, including strategic creative briefs and paid media plans, and
the dollar amount(s) and flighting of such plans, by channel and by
product, including a description of any of the following activities
that an applicant may have engaged in:
    (A) Use of competent and reliable data sources, methodologies, and
technologies to establish, maintain, and monitor highly targeted
advertising and marketing plans and media buys, including a list of all
data sources used to target advertising and marketing plans and media
buys;
    (B) Targeting of specific group(s) by age-range(s), including young
adults, ages 21 to 24, and other demographic or psychographic
characteristics that reflect the intended target audience, including
the source of such data;
    (C) With respect to individuals below the minimum age of sale,
actions taken to restrict access to the products and exposure to the
products' labeling, advertising, marketing, or promotion, or other
consumer-directed activities;
    (D) Use of owned, earned, shared, or paid media to create labeling
for, advertise, market, or promote the product;
    (E) Use of partners, influencers, bloggers, or brand ambassadors to
create labeling for, advertise, market, or promote the product;
    (F) Consumer engagements conducted by the applicant, on its behalf,
or at its direction, including events at which the products were
demonstrated and how access was restricted to individuals at or above
the minimum age of sale;
    (G) Use of public-relations or other communications outreach to
create labeling for, advertise, market, or promote the products;
    (xvi) A summary of media tracking and optimization, by channel, by
product, and by audience demographics (e.g., age, gender, race/
ethnicity, geographic region), including a summary of any real-time
digital media monitoring and including a summary of implementation of
any corrective and preventive measures to identify, correct, and
prevent delivery of advertising to individuals below the minimum age of
sale, not previously submitted;
    (xvii) An analysis of the actual delivery of advertising
impressions, by channel, by product, and by audience demographics, that
have not been previously submitted, and verified against post-launch
delivery-verification reports submitted to the applicant from an
accredited source, where applicable;
    (xviii) Additional information required to be reported under the
terms of a marketing granted order (if applicable); and
    (xix) An overall assessment of how the tobacco product continues to
be appropriate for the protection of the public health.
    (2) Serious and unexpected adverse experience reporting. The
applicant must report all serious and unexpected adverse experiences
associated with the tobacco product that have been reported to the
applicant or of which the applicant is aware to CTP's Office of Science
through the Health and Human Services' Safety Reporting Portal or in
another manner designated by FDA (if applicable) within 15 calendar
days after the report is received by the applicant.
    (b) FDA review of postmarket reports. (1) As part of its review of
a postmarket report, FDA may require the applicant to submit additional
information to enable it to determine whether a change results in a new
tobacco product, or to facilitate a determination of whether there are
or may be grounds to withdraw or temporarily suspend the marketing
granted order.
    (2) FDA may notify an applicant that FDA has determined that a
change described in a periodic report made under this section results
in a new tobacco product outside the scope of the marketing granted
order, requiring the submission of a new PMTA under Sec.  1114.7 or a
supplemental PMTA under Sec.  1114.15 and issuance of a marketing
granted order if the applicant seeks to market the new tobacco product,
unless the new tobacco product can be legally marketed through a
different premarket pathway.

Subpart E--Miscellaneous

Sec.  1114.45   Record retention.

    (a) Record retention by the applicant. (1) Each applicant that
receives a marketing granted order must maintain all records necessary
to facilitate a determination of whether there are or may be grounds to
withdraw or temporarily suspend the marketing granted order, including
records related to both the application and postmarket reports, and
ensure that such records remain readily available to the Agency upon
request (including where records are maintained by a third party on an
applicant's behalf). These records include, but are not limited to:

    (i) All documents submitted to FDA as part of an application,
periodic postmarket reports, and adverse experience reports;
    (ii) All documentation demonstrating whether each:
    (A) Nonclinical laboratory study was conducted in accordance with
good laboratory practices that support the reliability of the results,
such as the records described in part 58 of this chapter; and
    (B) Clinical investigator has any financial conflicts of interest
that may be a source of bias, such as the documentation described in
part 54 of this chapter;
    (iii) All other documents generated during the course of a study
necessary to substantiate the study results, including:
    (A) Communications related to the investigation between the
investigator and the sponsor, the monitor, or FDA; and
    (B) All source data for human subject and nonclinical
investigations included in the application and postmarket reports,
including records of each study subject's case history and exposure to
tobacco products used in the investigation, including case report
forms, progress notes, hospital records, clinical charts, X-rays, lab
reports, and subject diaries; and
    (iv) A list of each complaint, and a summary and analysis of all
complaints, associated with the tobacco product reported to the
applicant;
    (2) These records must be legible, in the English language, and
available for inspection and copying by officers or employees duly
designated by the Secretary. Documents that have been translated from
another language into English (e.g., original study documents written
in a language other than English) must be accompanied by the original
language version of the document, a signed statement by an authorized
representative of the manufacturer certifying that the English language
translation is complete and accurate, and a brief statement of the
qualifications of the person that made the translation.
    (3) All records must be retained as follows:
    (i) Records related to and including the PMTA must be retained for
a period of at least 4 years from the date that the marketing granted
order is issued.
    (ii) Records related to postmarket reports, including both periodic
and adverse experience reports, must be retained for a period of at
least 4 years from the date the report was submitted to FDA or until
FDA inspects the records, whichever occurs sooner.
    (b) Record retention by FDA. FDA will retain information submitted
to it in accordance with Federal Agency Records schedules and will
provide a copy to persons to whom such information may legally be
disclosed on request under the fee schedule in FDA's public information
regulations in Sec.  20.45 of this chapter.

Sec.  1114.47  Confidentiality.

    (a) General. FDA will determine the public availability of any part
of an application and other content related to such an application,
including all data and information submitted with or incorporated by
reference in the application, under this section and part 20 of this
chapter.
    (b) Confidentiality of data and information prior to an order.
Prior to issuing an order under this part:
    (1) FDA will not publicly disclose the existence of an application
unless:
    (i) The applicant has publicly disclosed or acknowledged (as such
disclosure is defined in Sec.  20.81 of this chapter), or has
authorized FDA in writing to publicly disclose or acknowledge, that the
applicant has submitted an application to FDA; or
    (ii) FDA refers the application to TPSAC.
    (2) Except as described in paragraph (b)(4) of this section, FDA
will not disclose the existence or contents of an FDA communication
with an applicant regarding its application except to the extent that
the applicant has publicly disclosed or acknowledged, or authorized FDA
in writing to publicly disclose or acknowledge, the existence or
contents of that particular FDA communication.
    (3) Except as described in paragraph (b)(4) of this section, FDA
will not disclose the existence or contents of information contained in
an application unless the applicant has publicly disclosed or
acknowledged, or authorized FDA in writing to publicly disclose or
acknowledge, the existence or contents of that particular information.
If the applicant has publicly disclosed or acknowledged, or authorized
FDA in writing to publicly disclose or acknowledge, the existence or
contents of that particular information contained in an application,
FDA may disclose the existence or contents of that particular
information.
    (4) If FDA refers an application to TPSAC, the contents of the
application will be available for public disclosure, except information
that is exempt from disclosure under part 20 of this chapter.
    (c) Disclosure of data and information after issuance of a
marketing granted order. After FDA issues a marketing granted order, it
may make the following information related to the application and order
available for public disclosure upon request or at FDA's own
initiative, including information from amendments to the application
and FDA's reviews of the application:
    (1) All data previously disclosed to the public, as such disclosure
is defined in Sec.  20.81 of this chapter;
    (2) Any protocol for a test or study, unless it is shown to fall
within the exemption established for trade secrets and confidential
commercial information in Sec.  20.61 of this chapter;
    (3) Information and data submitted to demonstrate that the new
tobacco product is appropriate for the protection of public health,
unless the information is shown to fall within the exemptions
established in Sec.  20.61 of this chapter for trade secrets and
confidential commercial information, or in Sec.  20.63 of this chapter
for personal privacy;
    (4) Correspondence between FDA and the applicant, including any
requests FDA made for additional information and responses to such
requests, and all written summaries of oral discussions between FDA and
the applicant, unless it is shown to fall within the exemptions in
Sec.  20.61 of this chapter for trade secrets and confidential
commercial information, or in Sec.  20.63 of this chapter for personal
privacy;
    (5) In accordance with Sec.  25.51(b) of this chapter, the
environmental assessment or, if applicable, the claim for categorical
exclusion from the requirement to submit an environmental assessment
under part 25 of this chapter; and
    (6) Information and data contained in postmarket reports submitted
to FDA, unless the information is shown to fall within the exemptions
established in Sec.  20.61 of this chapter for trade secrets and
confidential commercial information, or in Sec.  20.63 of this chapter
for personal privacy
    (d) Disclosure of data and information after the issuance of a
marketing denial order. After FDA issues a marketing denial order, FDA
may make certain information related to the application and the order
available for public disclosure upon request or at FDA's own initiative
unless the information is otherwise exempt from disclosure under part
20 of this chapter. Information FDA may disclose includes, but is not
limited to the tobacco product category (e.g., cigarette), tobacco
product subcategory (e.g., filtered, combusted cigarette), package
size, product quantity, characterizing flavor, and the basis for the
marketing denial order.

Sec.  1114.49  Electronic submission.

    (a) Electronic format requirement. Applicants submitting any
documents to the Agency under this part must provide all required
information to FDA using the Agency's electronic system, except as
provided in paragraph (b) of this section. The application and all
supporting information must be submitted in an electronic format that
FDA can process, review, and archive.
    (b) Waivers from electronic format requirement. An applicant may
submit a written request, that is legible and in English, to the Center
for Tobacco Products asking that FDA waive the requirement for
electronic format and content. Waivers will be granted if use of
electronic means is not reasonable for the applicant. To request a
waiver, applicants can send the written request to the address included
on our website (www.fda.gov/tobacco-products). The request must include
the following information:
    (1) The name and address of the applicant, a list of individuals
authorized by the applicant to serve as the contact person and contact
information. If the applicant has submitted a PMTA previously, the
regulatory correspondence should also include any identifying
information about the previous submission.
    (2) A statement that creation and/or submission of information in
electronic format is not reasonable for the applicant, and an
explanation of why creation and/or submission in electronic format is
not reasonable. This statement must be signed by the applicant or by a
representative who is authorized to make the declaration on behalf of
the applicant.
    (c) Paper submission. An applicant who has obtained a waiver from
filing electronically must send a written application through the
Document Control Center to the address provided in the FDA
documentation granting the waiver.

    Dated: September 21, 2021.
Janet Woodcock,
Acting Commissioner of Food and Drugs.
[FR Doc. 2021-21011 Filed 10-4-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 68 (Wednesday, April 8, 2020)]
[Proposed Rules]
[Pages 19707-19709]
[FR Doc No: 2020-07354]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-0214; Product Identifier 2018-SW-039-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for all Airbus Helicopters Model EC225LP helicopters. This proposed AD
was prompted by a mechanical deformation found on the protective cover
of the ``SHEAR'' control pushbutton installed on a copilot collective
stick. This proposed AD would require modification of the helicopter by
replacing the protective cover and re-identifying the part number (P/N)
of the pilot and copilot collective sticks. The FAA is proposing this
AD to address the unsafe condition on these products.

DATES: The FAA must receive comments on this proposed AD by May 26,
2020.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Airbus
Helicopters, 2701 N. Forum Drive, Grand Prairie, TX 75052; telephone
(972) 641-0000 or<PHONE_NUMBER>; fax<PHONE_NUMBER>; or at https://www.airbus.com/helicopters/services/technical-support.html. You may
view this service information at the FAA, Office of the Regional
Counsel, Southwest Region, 10101 Hillwood Pkwy, Room 6N-321, Fort
Worth, TX 76177.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
0214; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this NPRM, the Mandatory Continuing Airworthiness Information (MCAI),
any comments received, and other information. The street address for
Docket Operations is listed above. Comments will be available in the AD
docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Clark Davenport, Flight Test Analyst,
Flight Test Branch, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177;
telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2020-0214;
Product Identifier 2018-SW-039-AD'' at the beginning of your comments.
The FAA specifically invites comments on the overall regulatory,
economic, environmental, and energy aspects of this NPRM. The FAA will
consider all comments received by the closing date and may amend this
NPRM because of those comments.
    The FAA will post all comments received, without change, to https://www.regulations.gov, including any personal information you provide.
The FAA will also post a report summarizing each substantive verbal
contact received about this NPRM.

Discussion

    The European Union Aviation Safety Agency (previously European
Aviation Safety Agency) (EASA), which is the Technical Agent for the
Member States of the European Union, has issued EASA AD No. 2018-0106,
dated May 10, 2018 (referred to after this as ``the MCAI''), to correct
an unsafe condition for all Airbus Helicopters Model EC225LP
helicopters. EASA advises that mechanical deformation was found on the
protective cover of the ``SHEAR'' control pushbutton on a copilot
collective stick. The root cause for the deformation was identified as
incorrect handling. This condition, if not corrected, could lead to
unintended shearing of the hoist cable, possibly resulting in loss of a
hoisted load or person(s). To address this unsafe condition, the EASA
AD requires replacement of the protective cover of the ``SHEAR''
control pushbutton and re-identification (new AH P/N 704A41110149, new
NSE MP/N 00014100AA) of the pilot and copilot collective sticks. The
EASA AD also prohibits installation of the old design protective cover.
    You may examine the MCAI in the AD docket on the internet at
https://www.regulations.gov by searching for and locating Docket No.
FAA-2020-0214.

Related Service Information Under 1 CFR Part 51

    Airbus Helicopters has issued Alert Service Bulletin EC225-67A017,
Revision 0, dated March 26, 2018. This service information describes
procedures for modification of the helicopter by replacing the
protective

cover of the ``SHEAR'' control pushbutton and re-identifying the part
number of the pilot and copilot collective sticks.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

FAA's Determination

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to the FAA's bilateral agreement with the State of Design Authority,
the FAA has been notified of the unsafe condition described in the MCAI
and service information referenced above. The FAA is proposing this AD
after evaluating all the relevant information and determining the
unsafe condition described previously is likely to exist or develop on
other products of the same type design.

Proposed Requirements of This NPRM

    This proposed AD would require accomplishing the actions specified
in the service information described previously.

Costs of Compliance

    The FAA estimates that this proposed AD affects 12 helicopters of
U.S. registry. The FAA estimates the following costs to comply with
this proposed AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
2 work-hours x $85 per hour = $170...........................          $2,632           $2,802          $33,624
----------------------------------------------------------------------------------------------------------------

    According to the manufacturer, some or all of the costs of this
proposed AD may be covered under warranty, thereby reducing the cost
impact on affected individuals. The FAA does not control warranty
coverage for affected individuals. As a result, the FAA has included
all known costs in the cost estimate.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect 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.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

Airbus Helicopters: Docket No. FAA-2020-0214; Product Identifier
2018-SW-039-AD.

(a) Comments Due Date

    The FAA must receive comments by May 26, 2020.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Airbus Helicopters Model EC225LP
helicopters, certificated in any category.

(d) Subject

    Joint Aircraft System/Component Codes (JASC) Code 67, Rotorcraft
Flight Controls.

(e) Reason

    This AD was prompted by mechanical deformation found on the
protective cover of the ``SHEAR'' control pushbutton installed on a
copilot collective stick. The FAA is issuing this AD to address this
condition, which could lead to unintended shearing of the hoist
cable, possibly resulting in loss of a hoisted load or person(s).

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Definitions

    For the purposes of this AD, the definitions specified in
paragraphs (g)(1) through (3) of this AD apply.
    (1) Affected part: A pilot or copilot collective stick having
part number (P/N) 704A41110139, equipment manufacturer NSE P/N
N2000355.
    (2) Group 1 helicopters: Helicopters that have an affected part
installed.
    (3) Group 2 helicopters: Helicopters that do not have an
affected part installed. A helicopter that has embodied Airbus
Helicopters Modification 332P084165 in production is a Group 2
helicopter, provided that helicopter remains in that configuration.

(h) Required Actions

    For Group 1 helicopters: At the applicable time specified in
Table 1 to paragraph (h) of this AD, modify the helicopter by
replacing the protective cover of the ``SHEAR'' control pushbutton
and re-identifying the part number of the pilot and copilot
collective sticks, in accordance with the Accomplishment
Instructions of Airbus Helicopters Alert Service Bulletin EC225-
67A017, Revision 0, dated March 26, 2018.

[GRAPHIC] [TIFF OMITTED] TP08AP20.000

(i) Parts Installation Prohibition

    At the applicable times specified in paragraphs (i)(1) and (2)
of this AD: Do not install on any helicopter a ``SHEAR'' control
pushbutton protective cover having P/N 700070 on the pilot or
copilot collective stick, and do not install on any helicopter a
pilot or copilot collective stick having P/N 704A41110139 (equipment
manufacturer NSE P/N N2000355).
    (1) For Group 1 helicopters: After modification of the
helicopter as required by paragraph (h) of this AD.
    (2) For Group 2 helicopters: From the effective date of this AD.

(j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Section, Rotorcraft Standards
Branch, FAA, may approve AMOCs for this AD. Send your proposal to:
Clark Davenport, Flight Test Analyst, Flight Test Branch, FAA, 10101
Hillwood Pkwy., Fort Worth, TX 76177; telephone<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, notify your
principal inspector or lacking a principal inspector, the manager of
the local flight standards district office or certificate holding
district office, before operating any aircraft complying with this
AD through an AMOC.

(k) Related Information

    (1) The subject of this AD is addressed in European Union
Aviation Safety Agency (previously European Aviation Safety Agency)
(EASA) AD No. 2018-0106, dated May 10, 2018. This EASA AD may be
found in the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-
2020-0214.
    (2) For service information identified in this AD, contact
Airbus Helicopters, 2701 N. Forum Drive, Grand Prairie, TX 75052;
telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax<PHONE_NUMBER>; or
at https://www.airbus.com/helicopters/services/technical-support.html. You may view this service information at the FAA,
Office of the Regional Counsel, Southwest Region, 10101 Hillwood
Pkwy, Room 6N-321, Fort Worth, TX 76177.

    Issued on April 3, 2020.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2020-07354 Filed 4-7-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: November 28, 2008 (Volume 73, Number 230)]
[Notices]
[Page 72475-72476]
[DOCID:fr28no08-67]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PR09-6-000]

J-W Pipeline Company; Notice of Petition for Rate Approval

November 21, 2008.
    Take notice that on November 18, 2008, J-W Pipeline Company (J-W
Pipeline) filed a petition for rate approval pursuant to section
284.123(b)(2) of the Commission's regulations. J-W Pipeline proposes
the following rates for its NGPA section 311(a)(2) transportation
services on its Gravel Point South and Highway 5 South Lines: a demand
charge of $.8700 per MMBtu for firm transportation, with no commodity
charge for firm service, and a $.0286 per MMBtu for interruptible
transportation. J-W Pipeline also requests authority to retain from its
shippers actual compressor fuel and lost-and-unaccounted-for volumes on
the system, not to exceed 2% of volumes received by J-W Pipeline.
    Any person desiring to participate in this rate proceeding must
file a motion to intervene or to protest this filing must file in
accordance with Rules 211 and 214 of the Commission's Rules of Practice
and Procedure (18 CFR 385.211 and 385.214). Protests will be considered
by the Commission in determining the appropriate action to be taken,
but will not serve to make protestants parties to the proceeding. Any
person wishing to become a party must file a notice of intervention or
motion to intervene, as appropriate. Such notices, motions, or protests
must be filed on or before the date as indicated below. Anyone filing
an intervention or protest must serve a copy of that document on the
Applicant. Anyone filing an intervention or protest on or before the
intervention or protest date need not serve motions to intervene or
protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the

Web site that enables subscribers to receive e-mail notification when a
document is added to a subscribed docket(s). For assistance with any
FERC Online service, please e-mail<EMAIL_ADDRESS>or call
(866) 208-3676 (toll free). For TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time Monday, December 1, 2008.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-28280 Filed 11-26-08; 8:45 am]

BILLING CODE 6717-01-P


[Text in brackets is optional]
(Text in parenthesis is for the reviewer)

(Front Panel)

TAENURE GRANULAR BIOINSECTICIDE
[ABN: Met52(TM) GRANULAR BIOINSECTICIDE]

                                                                          % w/w
ACTIVE INGREDIENT  -  Metarhizium anisopliae Strain F52*................................
                                                                           2.0%
OTHER INGREDIENTS...................................................................................
                                                                          98.0%
Total
                                                                         100.0%
* Contains 9.0 x 10[8] Colony Forming Units (CFU)/gram.

                         KEEP OUT OF REACH OF CHILDREN
--------------------------------------------------------------------------------
CAUTION

PRECAUTIONARY STATEMENTS
                    HAZARDS TO HUMANS AND DOMESTIC ANIMALS
--------------------------------------------------------------------------------

Causes moderate eye irritation. Harmful if inhaled, absorbed through skin, or swallowed. Avoid contact with skin, eyes, or clothing. Avoid breathing dust. Wash thoroughly with soap and water after handling, and before eating, drinking, chewing gum, using tobacco, or using the toilet. Remove and wash contaminated clothing before reuse.

[REFER TO DIRECTIONS OF USE WITHIN THIS BOOKLET]

                                   FIRST AID
IF IN EYES:

Hold eye open and rinse slowly and gently with water for 15  -  20 minutes.  Remove contact lenses, if present, after the first 5 minutes, then continue rinsing eye.  Call a poison control center or doctor for treatment advice.

IF INHALED:

Move person to fresh air.  If person is not breathing, call 911 or an ambulance, then give artificial respiration, preferably mouth-to-mouth if possible. Call a poison control center or doctor for further treatment advice.

IF ON SKIN OR CLOTHING:

Take off contaminated clothing.  Rinse skin immediately with plenty of water for 15  -  20 minutes.  Call a poison control center or doctor for treatment advice.

IF SWALLOWED:

Call a poison control center or doctor immediately for treatment advice.  Have a person sip a glass of water if able to swallow.  Do not induce vomiting unless told to do so by a poison control center or doctor.  Do not give anything by mouth to an unconscious person.

                                HOT LINE NUMBER
Have the product container or label with you when calling a poison control center or doctor or going for treatment. For emergency information on this pesticide product (including health concerns, medical emergencies, or pesticide incidents) call the National Pesticide Information Center at 1-800-858-7378 6:30 a.m.  -  4:30 p.m. Pacific Time (PT), seven days a week.  During other times call the poison control center at 1-800-222-1222.

                    Batch Code/Expiry Date:  _____________
         Net Contents: [3 Lbs.][5 Lbs.][22 Lbs.][25 Lbs.][bag][XX Kg.]

[Produced for:]
Novozymes Biologicals Inc.
                                     EPA Establishment Number:  [070127-VA-001]
                                                               [085238-CAN-001]
5400 Corporate Circle
                                              EPA Registration Number:  70127-8
Salem, VA 24153, USA
                                                         Made in [USA] [Canada]
1-888-744-5662
                                                      [www.bioag.novozymes.com]

[NOVOZYMES RETHINK TOMORROW] [LOGO]

(End Front Panel)
                         PERSONAL PROTECTIVE EQUIPMENT
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
Mixer/loaders, applicators and other handlers must wear:
--------------------------------------------------------------------------------

* --------------------------------------------------------------------------------
Long-sleeved shirt and long pants
* --------------------------------------------------------------------------------
Waterproof gloves
* --------------------------------------------------------------------------------
Shoes and socks
* --------------------------------------------------------------------------------
Protective eyewear
* --------------------------------------------------------------------------------
Dust-mist filtering respirator (MSHA/NIOSH approval number prefix TC-21C) or a NIOSH approved respirator with any N-95, R-95, P-95 or HE filter.
* --------------------------------------------------------------------------------
Repeated exposure to high concentrations of microbial proteins can cause allergic sensitization.
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
Follow manufacturer's instructions for cleaning/maintaining PPE.  If no such instructions for washables, use detergent and hot water.  Keep and wash PPE separately from other laundry.
--------------------------------------------------------------------------------

                             ENGINEERING CONTROLS
When handlers use closed systems or enclosed cabs in a manner that meets the requirements listed in the Worker Protection Standard (WPS) for agricultural pesticides [40 CFR 170.240(d)(4-6)], the handler PPE requirements may be reduced or modified as specified in the WPS.

IMPORTANT: When reduced PPE is worn because a closed system is being used, handlers must be provided all PPE specified above for "applicators and other handlers" and have such PPE immediately available for use in an emergency, such as a spill or equipment break-down.

--------------------------------------------------------------------------------
USER SAFETY RECOMMENDATIONS
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
*	Users should remove clothing immediately if pesticide gets inside, then wash thoroughly and put on clean clothing.
--------------------------------------------------------------------------------
*	Remove personal protection equipment immediately after handling this product.  Wash the outside of gloves before removing.  As soon as possible, wash thoroughly and change into clean clothing.
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
ENVIRONMENTAL HAZARDS
For terrestrial uses. Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high water mark.  Do not contaminate water when disposing of equipment washwater or rinsate.

PHYSICAL OR CHEMICAL HAZARDS
For spill, leak, fire, exposure, or accident call CHEMTREC at 1-800-424-9300,day or night.
DIRECTIONS FOR USE

It is a violation of Federal law to use this product in a manner inconsistent with its labeling.

Do not apply this product in a way that will contact workers or other persons, either directly or through drift.  Only protected handlers may be in the area during application.  For any requirements specific to your State or Tribe, consult the state or tribal agency responsible for pesticide regulation.

--------------------------------------------------------------------------------
AGRICULTURAL USE REQUIREMENTS
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
Use this product only in accordance with its labeling and with the Worker Protection Standard, 40 CFR part 170.  This Standard contains requirements for the protection of agricultural workers on farms, forests, nurseries and greenhouses, and handlers of agricultural pesticides.  It contains requirements for training, decontamination, notification, and emergency assistance.  It also contains specific instructions and exceptions pertaining to the statements on this label about personal protective equipment (PPE) and restricted-entry interval.  The requirements in this box only apply to uses of this product that are covered by the Worker Protection Standard.
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
For uses that are soil incorporated mechanically, there is a 0 hour Restricted Entry Interval (REI) -  the Worker Protection Standard allows workers to enter the treated area if there will be no contact with anything that has been treated.  For all other uses, do not enter or allow worker entry into treated areas during the REI of four hours.
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
PPE required for early entry to treated areas requiring a REI that is permitted under the Worker Protection Standard and that involves contact with anything that has been treated, such as plants, soil, or water are:
--------------------------------------------------------------------------------
	Coveralls
--------------------------------------------------------------------------------
	Waterproof gloves
--------------------------------------------------------------------------------
	Shoes plus socks
--------------------------------------------------------------------------------
	Protective eyewear
--------------------------------------------------------------------------------
	Dust-mist filtering respirator (MSHA/NIOSH approval number prefix TC-21C) or a NIOSH approved respirator with any N-95, R-95, P-95 or HE filter.
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
NON-AGRICULTURAL USE REQUIREMENTS
--------------------------------------------------------------------------------
The requirements in this box apply to uses that are NOT within the scope of the Worker Protection Standard for agricultural pesticides (40 CFR Part 170).  The WPS applies when this product is used to produce agricultural plants on farms, forests, nurseries or greenhouses.
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
Keep unprotected persons out of treated areas until sprays have dried.

                                    GENERAL

Taenure Granular Bioinsecticide is composed of spores of the insect pathogenic fungus Metarhizium anisopliae Strain F52 on a grain matrix.  Once the product is incorporated into the growing medium, insects that come into contact with the fungus will become infected.  The spores of Metarhizium anisopliae attach to the surface of the insect, germinate, and begin to grow.  It will penetrate the exoskeleton of the insect and grow inside the insect, causing the insect to die.  Under moderate temperatures it usually takes 3 to 7 days once the insect is exposed for death to occur. At very cold or hot temperatures death may occur more slowly.The fungal spores will be more persistent when incorporated in the soil, especially in potting media, than when applied to foliage.

Note: Taenure Granular Bioinsecticide contains live spores that may be harmed by storage at high temperatures. See storage and disposal section for more information.

MODE OF ACTION AND APPLICATION TIMING: Application frequency will depend on the environment to which Taenure Granular Bioinsecticide is applied and the target insects' life cycle. Persistence of Taenure Granular Bioinsecticide will generally be higher when incorporated into soil. Applications to leaf litter and turf may be done on a four to six week interval with an expected residual efficacy of a few months.

When possible, application to soil should be done in advance of when target insect will be passing through the top six inches of soil. A residual efficacy of a few months can be expected. Although the penetration of Taenure Granular Bioinsecticide into soil will vary greatly with soil type and level of irrigation it is best to target populations as close to the surface as possible or time application of Taenure Granular Bioinsecticide with a soil incorporation event.

Once the product is incorporated into the growing medium, insects that come into contact with the fungus become infected. The spores attach to the surface of the insect, germinate and grow. Under moderate temperatures it usually takes 3 to 7 days, once the insect is exposed for death to occur. At very cold or hot temperatures death may occur more slowly.The fungal spores will be more persistent when incorporated in the soil, especially in potting media, than when applied to foliage. Taenure Granular Bioinsecticide has been demonstrated to last through two black vine weevil egg laying seasons when incorporated into growing media in the spring before egg lay. Other insects that come into contact with infected insects may also be infected extending the control period.

PRE-HARVEST INTERVAL: The pre-harvest interval for Taenure Granular Bioinsecticide is zero (0) days. Taenure Granular Bioinsecticide may be applied up to the day of harvest.

                                 SITES FOR USE

TERRESTRIAL NON-FOOD: Greenhouse ornamental, nurseries, urban and suburban residential and institutional lawns and landscape perimeters. Do not apply on poinsettias after bract formation.

FOOD CROPS: Taenure Granular Bioinsecticide can be applied to the crops listed in Table 1. Taenure Granular Bioinsecticide has shown plant safety but has not been tested on all varieties. Test Taenure Granular Bioinsecticide on a small number of plants to check for potential damage before applying to a large number of plants.

APPLICATION INSTRUCTIONS

NURSERY PLANTING MIX: Apply Taenure Granular Bioinsecticide prior to or during planting by thoroughly mixing the product into the growing medium, ensuring even distribution.  It may help distribution to first apply the full concentration to a smaller volume of growing media such as to 1/3 to 1/10 of the total volume and then mix this concentrated growing media with the full volume. Apply at a rate of 1.5 to 3.0 lbs. of product per cubic yard of growing medium (or 25 to 50 grams per cubic foot of growing medium). Use higher label rates when larval pressure is expected to be high.

Taenure Granular Bioinsecticide is grown on rice grains that will decompose in the growing media.  Pests likely to be attracted by grains, such as rodents, must be controlled prior to use of this product.

APPLICATION TO TURF: Apply 1 to 3 pounds of Taenure Granular to 1000 square feet in residential and institutional lawns and landscape perimeters. Applications for blacklegged ticks should focus on the border of manicured lawns and paths creating a minimum of a 9 foot border. Applications for more mobile ticks such as the lonestar tick should cover a wider area and include the entire lawn. Initial applications should begin in the spring before ticks become active and continue at 4 to 8 week intervals throughout their active season.

TABLE 1: CROPS ON WHICH TAENURE GRANULAR MAY BE USED:

CROP
PEST
APPLICATION
RATE
Onions
thrip pupae
nursery planting mix
1.5-3.0 lbs/ yd³
Celery, lettuce, spinach
thrip pupae
nursery planting mix
1.5-3.0 lbs/ yd³
Peppers, tomatoes
thrip pupae
nursery planting mix
1.5-3.0 lbs/ yd³
Grape, strawberry, cranberry, raspberry, blackberry
thrip pupae, vine weevils
nursery planting mix
1.5-3.0 lbs/ yd³
Ornamental plants and grasses: shrubs, vines, trees, bedding plants, etc.
thrip pupae, vine weevils
nursery planting mix
1.5-3.0 lbs/ yd³
Turf: institutional, residential lawns (urban and suburban)
ticks
broadcast
1.0-3.0 lbs/ 1000 ft²

Applicators other than homeowners:

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

--------------------------------------------------------------------------------
STORAGE AND DISPOSAL
--------------------------------------------------------------------------------
Do not contaminate water, food, or feed by storage or disposal.
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
PESTICIDE STORAGE
--------------------------------------------------------------------------------
Store Taenure Granular Bioinsecticide in its original container below 73°F (23°C), in a dry, locked place out of reach of children and out of direct sunlight.  Do not use or store near heat or open flame. Use product within one year and by the expiry date noted on the label.
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
PESTICIDE DISPOSAL
--------------------------------------------------------------------------------
To avoid wastes, use all material in this container by application according to label directions.
--------------------------------------------------------------------------------
If wastes cannot be avoided, offer remaining product to a waste disposal facility or pesticide
--------------------------------------------------------------------------------
disposal program (often such programs are run by state or local govemments or by industry).
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
CONTAINER HANDLING
--------------------------------------------------------------------------------
Nonrefillable container. Do not reuse or refill this container. Completely empty bag into application equipment. Then offer for recycling, if available, or dispose of empty bag in a sanitary landfill or by incineration.  Do not burn, unless allowed by state and local ordinances.
--------------------------------------------------------------------------------

Homeowners:
--------------------------------------------------------------------------------
STORAGE AND DISPOSAL
--------------------------------------------------------------------------------
Do not contaminate water, food, or feed by storage or disposal.
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
PESTICIDE STORAGE
--------------------------------------------------------------------------------
Store Taenure Granular Bioinsecticide in its original container below 73°F (23°C), in a dry, locked place out of reach of children and out of direct sunlight.  Do not use or store near heat or open flame. Use product within one year and by the expiry date noted on the label.
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
PESTICIDE DISPOSAL AND CONTAINER HANDLING:
--------------------------------------------------------------------------------
Nonrefillable container. Do not reuse or refill container.
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
If empty:
--------------------------------------------------------------------------------
Place container in trash, or offer for recycling if available.
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
If partly filled:
--------------------------------------------------------------------------------
CALL YOUR LOCAL SOLID waste agency for disposal intructions. Never place unused product down any indoor or outdoor drain.
                                   WARRANTY

The Directions for Use of this product reflect the opinion of experts based on field use and tests.  The directions are believed to be reliable and must be followed carefully.

Novozymes Biologicals warrants that at the time of the first sale of this product it conforms to the chemical description on the label and when used according to the label directions under normal growing conditions is reasonably fit for the purposes referred to above.  To the extent consistent with applicable law, buyers/users of this product assume full risk for any use contrary to the specified directions.  If this product does not perform as warranted above, customer's sole remedy for breach of warranty, to the extent consistent with applicable law, shall be replacement of the product or refund of the purchase price paid, at the option of Novozymes Biologicals.

TO THE EXTENT CONSISTENT WITH APPLICABLE LAW, EXCEPT AS PROVIDED ELSEWHERE IN WRITING CONTAINING AN EXPRESS REFERENCE TO THIS WARRANTY AND LIMITATION OF DAMAGES, SELLER MAKES NO OTHER EXPRESS OR IMPLIED WARRANTY OR GUARANTEE, INCLUDING ANY OTHER EXPRESS OR IMPLIED WARRANTY OF FITNESS OR OF MERCHANTABILITY, AND NO AGENT OF SELLER IS AUTHORIZED TO DO SO.

[(R)MET52 is a registered trademark of Novozymes A/S (C)2010 Novozymes. All rights reserved]

[Text in brackets is optional]
(Text in parenthesis is for the reviewer)

(Back Panel)

TAENURE GRANULAR BIOINSECTICIDE
[ABN: Met52(TM) GRANULAR BIOINSECTICIDE]

                                                                          % w/w
ACTIVE INGREDIENT  -  Metarhizium anisopliae Strain F52*................................
                                                                           2.0%
OTHER INGREDIENTS...................................................................................
                                                                          98.0%
Total
                                                                         100.0%
* Contains 9.0 x 10[8] Colony Forming Units (CFU)/gram.

                         KEEP OUT OF REACH OF CHILDREN
--------------------------------------------------------------------------------
CAUTION

PRECAUTIONARY STATEMENTS
                    HAZARDS TO HUMANS AND DOMESTIC ANIMALS
--------------------------------------------------------------------------------

Causes moderate eye irritation. Harmful if inhaled, absorbed through skin, or swallowed. Avoid contact with skin, eyes, or clothing. Avoid breathing dust. Wash thoroughly with soap and water after handling, and before eating, drinking, chewing gum, using tobacco, or using the toilet. Remove and wash contaminated clothing before reuse.

[REFER TO DIRECTIONS OF USE WITHIN THIS BOOKLET]

                                   FIRST AID
IF IN EYES:

Hold eye open and rinse slowly and gently with water for 15  -  20 minutes.  Remove contact lenses, if present, after the first 5 minutes, then continue rinsing eye.  Call a poison control center or doctor for treatment advice.

IF INHALED:

Move person to fresh air.  If person is not breathing, call 911 or an ambulance, then give artificial respiration, preferably mouth-to-mouth if possible. Call a poison control center or doctor for further treatment advice.

IF ON SKIN OR CLOTHING:

Take off contaminated clothing.  Rinse skin immediately with plenty of water for 15  -  20 minutes.  Call a poison control center or doctor for treatment advice.

IF SWALLOWED:

Call a poison control center or doctor immediately for treatment advice.  Have a person sip a glass of water if able to swallow.  Do not induce vomiting unless told to do so by a poison control center or doctor.  Do not give anything by mouth to an unconscious person.

                                HOT LINE NUMBER
Have the product container or label with you when calling a poison control center or doctor or going for treatment. For emergency information on this pesticide product (including health concerns, medical emergencies, or pesticide incidents) call the National Pesticide Information Center at 1-800-858-7378 6:30 a.m.  -  4:30 p.m. Pacific Time (PT), seven days a week.  During other times call the poison control center at 1-800-222-1222.

         Net Contents: [3 Lbs.][5 Lbs.][22 Lbs.][25 Lbs.][bag][XX kg]

[Produced for:]
Novozymes Biologicals Inc.
                                     EPA Establishment Number:  [070127-VA-001]
                                                               [085238-CAN-001]
5400 Corporate Circle
                                              EPA Registration Number:  70127-8
Salem, VA 24153, USA
                                                         Made in [USA] [Canada]
1-888-744-5662
                                                      [www.bioag.novozymes.com]

[NOVOZYMES RETHINK TOMORROW] [LOGO]

Applicators other than homeowners:

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

--------------------------------------------------------------------------------
STORAGE AND DISPOSAL
--------------------------------------------------------------------------------
Do not contaminate water, food, or feed by storage or disposal.
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
PESTICIDE STORAGE
--------------------------------------------------------------------------------
Store Taenure Granular Bioinsecticide in its original container below 73°F (23°C), in a dry, locked place out of reach of children and out of direct sunlight.  Do not use or store near heat or open flame. Use product within one year and by the expiry date noted on the label.
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
PESTICIDE DISPOSAL
--------------------------------------------------------------------------------
To avoid wastes, use all material in this container by application according to label directions.
--------------------------------------------------------------------------------
If wastes cannot be avoided, offer remaining product to a waste disposal facility or pesticide
--------------------------------------------------------------------------------
disposal program (often such programs are run by state or local govemments or by industry).
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
CONTAINER HANDLING
--------------------------------------------------------------------------------
Nonrefillable container. Do not reuse or refill this container. Completely empty bag into application equipment. Then offer for recycling, if available, or dispose of empty bag in a sanitary landfill or by incineration.  Do not burn, unless allowed by state and local ordinances.
--------------------------------------------------------------------------------

Homeowners:
--------------------------------------------------------------------------------
STORAGE AND DISPOSAL
--------------------------------------------------------------------------------
Do not contaminate water, food, or feed by storage or disposal.
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
PESTICIDE STORAGE
--------------------------------------------------------------------------------
Store Taenure Granular Bioinsecticide in its original container below 73°F (23°C), in a dry, locked place out of reach of children and out of direct sunlight.  Do not use or store near heat or open flame. Use product within one year and by the expiry date noted on the label.
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
PESTICIDE DISPOSAL AND CONTAINER HANDLING:
--------------------------------------------------------------------------------
Nonrefillable container. Do not reuse or refill container.
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
If empty:
--------------------------------------------------------------------------------
Place container in trash, or offer for recycling if available.
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
If partly filled:
--------------------------------------------------------------------------------
CALL YOUR LOCAL SOLID waste agency for disposal intructions. Never place unused product down any indoor or outdoor drain.

(End Back Panel)