(F) Reports of release testing performed on finished products to
demonstrate conformity with established specifications, including test
protocols, line data, and a summary of the results for each applicable
testing.
    (k) Health risk investigations--(1) Study types. The application
must contain full reports of all information, including the substantive
information required by Sec.  1114.27(b)(1)(ii) for application filing,
both favorable and unfavorable, published or known to, or which should
reasonably be known to, the applicant concerning investigations,
including nonclinical and human subject studies, which have been made
to show:
    (i) Health risks of the product. The potential health risks of the
tobacco product to users and nonusers, including potential exposures,
and whether the product may present different risks than other tobacco
products, including:
    (A) The health effects of the constituents, including HPHCs, at the
quantitative levels delivered to both users and nonusers under the
range of conditions under which the product might be used;
    (B) The toxicological profile of the new tobacco product related to
the route of administration, including the genotoxicity,
carcinogenicity, reproductive toxicity, immunotoxicity, acute toxicity,
and repeat dose (chronic) toxicity of the new tobacco product,
including those relative to other tobacco products. The toxicological
profile also includes information on the toxicity of the ingredients,
additives, and HPHCs, relative to the route of administration and the
range of potential levels of exposure resulting from the use of, or
exposure to, the new tobacco product, including studies which discuss
the toxicological effects of any leachables and extractables that can
appear from the container closure system and the ingredient mixture,
such as additive or synergistic effects;
    (C) The pharmacological profile of the new tobacco product,
including the pharmacokinetics, pharamacodynamics, metabolism, and
elimination profile, of any of the ingredients, additives, and HPHCs
for the range of potential levels of exposure resulting from the use
of, or exposure to, the new tobacco product relative to other tobacco
products. The applicant must specify whether the studies were conducted
in vitro, in vivo, ex vivo, or in silico; and
    (D) The health risks of the tobacco product compared to other
tobacco products on the market, never using tobacco products, quitting
tobacco product use, and using the tobacco product in conjunction with
other tobacco products.

    (ii) Impacts on tobacco use behavior of tobacco product users. How
the product and its label, labeling, and advertising will affect the
tobacco use behavior of tobacco product users, including:
    (A) The abuse liability of the tobacco product;
    (B) How users actually use the product, including use topography,
product use frequency, use trends over time, and how such use affects
the health risks of the product to individual users;
    (C) The likelihood that users will use the product in conjunction
with other tobacco products;
    (D) The likelihood that current tobacco product users will start
using the product;
    (E) The likelihood that current tobacco users who adopt the product
will switch to or switch back to other tobacco products that may
present increased risks to individual health; and
    (F) The likelihood that current tobacco users who may have
otherwise quit using tobacco products will instead start or continue to
use the product.
    (iii) Impacts on tobacco use initiation by nonusers, including
youth and young adults. The impact of the tobacco product, its label,
labeling, and advertising on tobacco use initiation by nonusers,
including:
    (A) The likelihood that consumers who have never used tobacco
products, particularly youth and young adults, will initiate use of the
tobacco product;
    (B) The likelihood that nonusers of tobacco products who adopt the
tobacco product will switch to other tobacco products that may present
higher levels of individual health risk; and
    (C) The likelihood that former users of tobacco products will re-
initiate use with the tobacco product.
    (iv) Perceptions and use intentions. The impact of the product and
its label, labeling, and advertising on individuals:
    (A) Perception of the product;
    (B) Use intentions; and
    (C) Ability to understand the labeling and instructions for use and
use the product in accordance with those instructions.
    (v) Human factors. The impact of human factors on product risk,
including discussion of use conditions, use environments, use related
hazards, estimated use error risk, potential unintended uses, risk
controls to ensure that harms and unintended consequences are
minimized, and adverse experiences related to such uses.
    (2) Literature search. The applicant must conduct a literature
search for each type of information described in paragraph (k)(1) of
this section, and the application must contain a description of the
literature search performed, including the databases searched and the
date searched, search terms, reasons for inclusion or exclusion of
documents, and the strategy for study quality assessment. The
application must also contain a bibliography of all published studies
and articles referenced in the application. If a literature search was
performed and resulted in no information found, the application must
contain a statement to that effect.
    (3) Study reports. The full report of each study included in the
application must describe the specific product studied and include the
following items, where applicable and to the extent reasonably
available. For applicable items not contained in the full report of an
investigation, the applicant must contain a description of the actions
taken to obtain the information and why the document is not reasonably
available.
    (i) Full copies of any published articles and other reference
materials;
    (ii) Documentation of all actions taken to ensure the reliability
of the study. For nonclinical laboratory studies, the application must
contain, for each study, documentation of all actions taken to ensure
the reliability of the study, e.g., documentation of whether the study
was conducted in accordance with good laboratory practices, such as
those specified in part 58 of this chapter. For studies involving human
subjects, to the extent reasonably available or obtainable, the
application must contain a certification that clinical investigators do
not have, or documentation fully disclosing, any financial conflicts of
interest, such as the financial arrangements specified in the Financial
Disclosure by Clinical Investigators regulation in part 54 of this
chapter;
    (iii) Copies of all versions of protocols and amendments that were
used in the study;
    (iv) Copies of all versions of investigator instructions, if any
were produced in addition to the protocol;
    (v) The statistical analysis plan, including a detailed description
of the statistical analyses used (including all variables, confounders,
and subgroup analyses), the scientific rationale for the choice of
sample sizes, and any amendments to the plan;
    (vi) Line data, including data definition files that include the
names of the variables, codes, and formats in each dataset, and copies
of programs and any necessary macro-programs used to create derived
datasets, and the results included in the study reports;
    (vii) A list of sites and clinical investigators that conducted the
study, including contact information and physical address(es);
    (viii) The location of all source data. If the site where the study
was conducted has not maintained all of the source data, indicate where
the data are located;
    (ix) The format of the records and data (e.g., electronic or hard
copy);
    (x) A list of all sites that had early termination and the reason
for early termination, along with any audit certificates and inspection
results, if applicable;
    (xi) A list of contractors who participated in the study, the role
of each contractor, and the initiation and termination dates of the
participation of each contractor;
    (xii) A signed full report of all findings;
    (xiii) For human subject studies:
    (A) All versions of study materials (e.g., consent forms,
questionnaires, stimuli) used;
    (B) All versions of case report forms used; and
    (C) Individual case report forms related to participant deaths,
other serious and unexpected adverse experiences, withdrawals, and
participant discontinuation where the study participant was exposed to
the tobacco product that is the subject of the PMTA or similar
products; and
    (xiv) For tobacco product perception and use intention studies that
use advertising as stimuli, a statement describing whether the
advertising used is representative of advertising that the applicant
intends to use in marketing the product. If the advertising is not
representative of the advertising an applicant intends to use in
marketing the product, the applicant must describe whether the study
results are still relevant to the likely impact of the advertising on
tobacco product perceptions and use intentions.
    (l) The effect on the population as a whole. The application must
contain an analysis and discussion of how the data and information
contained in the application establish that permitting the tobacco
product to be marketed would be appropriate for the protection of
public health determined with respect to the population as a whole,
including users and nonusers of the tobacco product. The analysis and
discussion must integrate all of the information regarding the product
and its likely effects on health, and tobacco use behavior, including
tobacco use cessation and initiation, to provide an overall assessment
of the likely effect that the marketing of the tobacco

product may have on overall tobacco-related morbidity and mortality.
    (m) Certification statement. The application must contain the
following certification, with the appropriate information inserted (as
indicated by parenthetical italicized text), signed by an authorized
representative of the applicant:

    ``I (name of responsible official) on behalf of the applicant,
(applicant name), hereby certify that the applicant will maintain
all records to substantiate the accuracy of this application for the
period of time required in 21 CFR 1114.45 and ensure that such
records remain readily available to FDA upon request. I certify that
this information and the accompanying submission are true and
correct, that no material fact has been omitted, and that I am
authorized to submit this on the applicant'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.''

Sec.  1114.9  Amendments.

    (a) General. FDA may request, or an applicant may submit on its own
initiative, an amendment to a PMTA containing information that is
necessary for FDA complete the review of a pending PMTA. An amendment
must include the appropriate form and specify the STN assigned to the
original submission and, if submitted other than at FDA's request, the
reason for submitting the amendment. An amendment must also include the
certification statement set forth in Sec.  1114.7(m), with the
appropriate information inserted, and signed by an authorized
representative of the applicant.
    (b) Review of an amendment. Submission of an amendment may affect
the timing of review of an amended submission as follows:
    (1) If the amendment is a major amendment (e.g., an amendment that
contains significant new data from a previously unreported study,
detailed new analyses of previously submitted data), FDA may restart
the 180-day review period after receipt of the amendment.
    (2) If FDA requests a minor amendment (i.e., an amendment that is
not a major amendment) and receives a written response submitting the
requested amendment, FDA may pause the review period for the number of
days elapsed between the date of the request and the date that FDA
receives the written response.
    (c) Failure to respond to amendment request. If FDA requests an
amendment and the applicant does not respond within 180 days of FDA's
request, FDA may consider the applicant to have submitted a request to
voluntarily withdraw the pending PMTA under Sec.  1114.11 and issue an
acknowledgment letter notifying the applicant of the withdrawal.
    (d) No amendment to closed or withdrawn application. An applicant
may not amend an application after FDA has closed the application
through an action under Sec.  1114.29 or it has been withdrawn under
Sec.  1114.11.

Sec.  1114.11   Withdrawal by applicant.

    (a) An applicant may at any time make a written request using the
appropriate form to withdraw a PMTA that FDA has not acted on as
described in Sec.  1114.29. The withdrawal request must state:
    (1) Whether the withdrawal is due to a health concern related to
the tobacco product and, if so, a description of those concerns,
including the extent, duration, and frequency of the health effects,
and what gave rise to the concerns, such as reports of adverse
experiences;
    (2) The application STN; and
    (3) The name(s) of the new tobacco product that is the subject of
the application.
    (b) An application will be considered withdrawn when FDA issues an
acknowledgement letter stating that the application has been withdrawn.
    (c) The application is an Agency record, even if withdrawn. FDA
will retain the withdrawn application under Federal Agency records
schedules. The availability of the withdrawn application will be
subject to FDA's public information regulation in Sec.  20.45 of this
chapter.

Sec.  1114.13   Change in ownership of an application.

    An applicant may transfer of ownership of a PMTA. At or before the
time of transfer, the new owner and the former owner must submit
information to FDA using the appropriate form as follows:
    (a) The new and former owner must sign and submit a notice to FDA
stating that all of the former applicant's rights and responsibilities
relating to the PMTA have been transferred to the new owner. This
notice must identify the name and address of the new owner and the PMTA
transferred by tobacco product name(s) and STN.
    (b) The new owner must sign and submit a notice to FDA containing
the following:
    (1) The new owner's commitment to agreements, promises, and
conditions made by the former owner and contained in the application
and marketing order, if applicable;
    (2) The date that the change in ownership is effective;
    (3) Either a statement that the new owner has a complete copy of
the application, including all amendments, the marketing order (if
applicable), and any records that are required to be kept under Sec.
1114.45, or a request for a copy of the application, including all
amendments, and the modified risk order (if applicable) from FDA's
files in accordance with part 20 of this chapter. In accordance with
the Freedom of Information Act, FDA will provide a copy of the
application to the new owner under the fee schedule in FDA's public
information regulations in Sec.  20.45 of this chapter; and
    (4) A certification that no modifications have been made to the
tobacco product since the application, including amendments (if any),
was submitted to FDA.

Sec.  1114.15   Supplemental applications.

    (a) Supplemental PMTA submission. Applicants that have received a
marketing order for a tobacco product may, as an alternative format of
submitting an application that meets the content requirements of Sec.
1114.7, submit a supplemental PMTA to seek marketing authorization for
modifications to such product, which result in a new tobacco product
under 910(a)(1) of the Federal Food, Drug, and Cosmetic Act.
Supplemental PMTAs must include new information concerning
modifications that create the new tobacco product but allow the
applicant to satisfy the remaining application requirements by cross-
referencing applicable content from the previously submitted PMTA for
the original tobacco product. Applicants may submit supplemental PMTAs
only for modifications that require the submission of limited new
information. An applicant may not submit a supplemental PMTA where:
    (1) Modifications to the product that result in the new tobacco
product require the submission of new information or revisions to the
PMTA for the original product to the extent that reviewing a
supplemental application 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.
    (2) The marketing order for the original tobacco product has been
withdrawn; or

    (3) The marketing order for the original tobacco product has been
temporarily suspended or is subject to temporary suspension or
withdrawal proceedings by FDA, except where authorized in writing by
FDA following a presubmission meeting.
    (b) Required format. The supplemental PMTA must comply with format
requirements of Sec.  1114.7(b), except that an applicant must include
content in a supplemental PMTA by cross-referencing a PMTA, or, where
applicable, a supplemental PMTA, for an original tobacco product that
is owned by that applicant and may include content by cross-referencing
a tobacco product master file and postmarket reports for the original
tobacco product. FDA will not consider content included by cross-
reference to other sources of information outside of the submission.
    (c) Required content. The supplemental PMTA 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 contain the full text of all the
information described in the following sections:
    (i) General information that identifies the submission as a
supplemental PMTA (as described in Sec.  1114.7(c));
    (ii) New product information (as described in paragraph (d) of this
section);
    (iii) Statement of compliance with part 25 of this chapter (as
described in Sec.  1114.7(g));
    (iv) Labeling (as described in Sec.  1114.7(f)) if the labeling is
not identical to the labeling submitted in the PMTA or postmarket
reports for the original product;
    (v) Postmarket information (as described in paragraph (e) of this
section); and
    (vi) Certification statement (as described in paragraph (f) of this
section);
    (2) The application must include the following sections by cross-
reference to the PMTA for the original tobacco product and contain any
additional information 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)) if the labeling is
identical to the labeling that was submitted in the PMTA or postmarket
reports for the original tobacco product;
    (iv) Summary of all research findings (as described in Sec.
1114.7(h));
    (v) Product formulation (as described in Sec.  1114.7(i));
    (vi) Manufacturing (as described in Sec.  1114.7(j)); and
    (vii) Health risk investigations (as described in Sec.  1114.7(k)).
    (d) New product information. The application must contain a section
that includes:
    (1) Full descriptions of each modification to the product and
comparisons to the original product version described in the previously
authorized PMTA;
    (2) A statement as to whether the new tobacco product, if it
receives a marketing order, will replace the original tobacco product,
will be a line extension of the original tobacco product, or will be
introduced as an additional product by the same manufacturer;
    (3) All data and information relating to each modification to the
product that would be required in an application under Sec.  1114.7;
and
    (4) A concluding summary of how the new tobacco product meets the
requirements to receive a marketing order, including how the data and
information contained in both the supplemental PMTA and cross-
referenced from the previously authorized PMTA constitute valid
scientific evidence and establishes that the PMTA meets the
requirements of section 910(c) of the Federal Food, Drug, and Cosmetic
Act to receive a marketing order, including that permitting the new
tobacco product to be marketed would be appropriate for the protection
of the public health determined with respect to the risks and benefits
on the population as a whole, including users and nonusers of the
tobacco product.
    (e) Postmarket reports. (1) If an applicant has submitted
postmarket reports for the original tobacco product, the applicant must
include all such reports in the application by cross-reference.
    (2) If an applicant is required to, but has not yet submitted a
postmarket report, the applicant must submit a report as part of its
application of all information required under Sec.  1114.41 covering
the period of time from when it received a marketing order to when it
submits the supplemental PMTA.
    (f) Certification statement. The application must contain the
following certification, with the appropriate information inserted as
indicated by parenthetical italicized text, signed by an authorized
representative of the applicant:

    ``I, (name of responsible official), on behalf of (name of
applicant), certify that (new tobacco product name) has a different
(describe each modification to the product) than (name of original
tobacco product) described in (STN of the PMTA for the original
product) but is otherwise identical to (name(s) of original tobacco
product). I certify that (name of applicant) understands this means
there is no other modification to the materials, ingredients,
design, composition, heating source, or any other feature of the
original tobacco product. I also certify that (name of applicant)
will maintain all records that substantiate the accuracy of this
application 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
applicant'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.''

Sec.  1114.17   Resubmissions.

    (a) General. An applicant may, as an alternative format of
submitting an application that meets the content requirements of Sec.
1114.7 or Sec.  1114.15 (if applicable), submit a resubmission to
address deficiencies set forth in a no marketing order. The
resubmission must contain new information necessary to address
application deficiencies and cross-reference applicable content from
the PMTA that received the no marketing order. An applicant may utilize
the resubmission format for the same tobacco product for which FDA
issued a no marketing order or a new tobacco product that results from
modifications to the product necessary to address the deficiencies
described in a no marketing 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 no marketing 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

no marketing order. 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 no marketing order by cross-reference and contain
all additional information 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 part 25 of this chapter (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 no marketing order, including all data
and information necessary to complete each response, and 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 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 the
following certification 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 no marketing
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 no marketing
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 include sufficient information required by
section 910(b)(1)(A) through (b)(1)(F) 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 information, including
information from published literature or bridged from an investigation
of another tobacco product, regarding:
    (A) The health risks of the new tobacco product (as described in
Sec.  1114.7(k)(1)(i)(A) through (C));
    (B) The health risks of the new tobacco product compared to the
health risks generally presented by both products in the same product
category and products in at least one different category that are used
by the consumers an applicant expects will use its new tobacco product
(as set forth 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,
including use frequency, use trends over time, and how such use affects
the health risks of the product to individual users (as set forth in
Sec.  1114.7(k)(1)(ii)(B));
    (E) The impact that marketing the new tobacco product would have on
the likelihood that current tobacco product users would start using the
new tobacco product, use the product in conjunction with other tobacco
products, and, after using the product, switch to or switch back to
other tobacco products that may present increased risks to individual
health (as set forth in Sec.  1114.7(k)(1)(ii)(C) through (F));
    (F) The impact that the marketing of the new tobacco product would
have on tobacco product use behavior of current nonusers of tobacco
products (as described in Sec.  1114.7(k)(1)(iii)); or
    (G) The impact of the product and its label, labeling, and
advertising on individuals' perception of the product and their use
intentions (as described in Sec.  1114.7(k)(1)(iv));
    (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, 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 order as described in Sec.  1114.31; or
    (f) Issue a no marketing order as described in Sec.  1114.33.

Sec.  1114.31  Issuance of a marketing order.

    (a) FDA will issue a marketing 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 order becomes effective on
the date it is issued.
    (b) FDA may include, as part of the marketing 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 order under section 910(c)(1)(B) of the
Federal Food, Drug, and Cosmetic Act to help FDA make the finding 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 no marketing order.

    (a) Issuance. FDA will issue a no marketing order if:
    (1) 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 no marketing order will, where
practicable, identify measures to remove the application from deniable
form.

Sec.  1114.35  Withdrawal of a marketing order.

    (a) Grounds for withdrawal. FDA may withdraw a marketing 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 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 order.
    (2) FDA may use information other than that submitted by the
applicant in deciding whether to withdraw a marketing order.
    (c) Informal hearing. Prior to withdrawing a marketing order, FDA
will offer the holder of the marketing 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
order an order withdrawing the marketing order for the new tobacco
product.
    (e) Public notice. FDA will give the public notice of an order
withdrawing a marketing order for a tobacco product and will announce
the basis of the withdrawal.

Sec.  1114.37  Temporary suspension of a marketing order.

    (a) FDA will temporarily suspend a marketing 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 order of a tobacco
product, FDA will offer the holder of the marketing order an
opportunity for an informal hearing under part 16 of this chapter.
    (c) If, after offering the holder of the marketing 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 order for a tobacco product.
    (d) After issuing an order temporarily suspending the marketing
order, FDA will proceed expeditiously to initiate proceedings to
withdraw the marketing order for the tobacco product.

Subpart D--Postmarket Requirements

Sec.  1114.39  Postmarket changes.

    A marketing 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 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. Except as specified in Sec.  1114.43, each
applicant that receives a marketing order must submit to FDA all
information required by the terms of the marketing 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 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 order
and will not result in a finding that the marketing 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 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, as well as 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, and tobacco use status;
    (vii) 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;
    (viii) 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;
    (ix) A description of the implementation of all advertising and
marketing plans, by channel and by product, and the dollar amount(s)
and flighting of such plans, by channel and

by product, including a description of any:
    (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;
    (B) Targeting of specific adult audiences by age-range(s),
including young adults, ages 18 to 24, and other demographic or
psychographic characteristics that reflect the intended target
audience, including a list of all data sources used to target
advertising and marketing plans and media buys;
    (C) Actions taken to restrict youth-access and limit youth-exposure
to the products' labeling, advertising, marketing, or promotion;
    (D) Use of owned, earned, shared, or paid social media to create
labeling for, advertise, market, or promote the products;
    (E) Use of partners, influencers, bloggers, or brand ambassadors to
create labeling for, advertise, market, or promote the products;
    (F) Consumer engagements conducted by the applicant, on its behalf,
or at its direction, including events at which the products were
demonstrated; and
    (G) Use of earned media or public-relations outreach to create
labeling for, advertise, market, or promote the products;
    (x) An analysis of the actual delivery of advertising impressions,
by channel, by product (if applicable), and by audience demographics,
including a breakout by age-group, that have not been previously
submitted, verified against post-launch delivery-verification reports
submitted to the applicant from an accredited source;
    (xi) Additional information required to be reported under the terms
of a marketing order (if applicable); and
    (xii) 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 that the applicant is aware of 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
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 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 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 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 order, including records
related to both the application and postmarket reports, and ensure that
such records remain readily available to the Agency upon request. 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 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
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) 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 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 of that
particular information. If the applicant has publicly disclosed or
acknowledged, or authorized FDA in writing to publicly disclose or
acknowledge, the existence of that particular information contained in
an application, FDA may disclose the existence of that particular
information.
    (4) If FDA refers an application to TPSAC, the contents of the
application will be available for public disclosure under part 20 of
this chapter, except information that has been shown to fall within the
exemption established for trade secrets and confidential commercial or
financial information in Sec.  20.61, or personal privacy in Sec.
20.63.
    (c) Disclosure of data and information after issuance of a
marketing order. After FDA issues a marketing 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 no
marketing order. After FDA issues a no marketing 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 no
marketing 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 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/tobaccoproducts). 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: July 24, 2019.
Norman E. Sharpless,
Acting Commissioner of Food and Drugs.
    Dated: September 3, 2019.
Eric D. Hargan,
Deputy Secretary, Department of Health and Human Services.
[FR Doc. 2019-20315 Filed 9-20-19; 8:45 am]
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[Federal Register: May 1, 2009 (Volume 74, Number 83)]
[Notices]
[Page 20327]
[DOCID:fr01my09-61]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-1830-DR; Docket ID FEMA-2008-0018]

Minnesota; Amendment No. 3 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Minnesota (FEMA-1830-DR), dated April 9, 2009, and
related determinations.

DATES: Effective Date: April 22, 2009.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Disaster Assistance
Directorate, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Minnesota is hereby amended to include the following
areas among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of April 9, 2009.

    Becker, Beltrami, Chippewa, Clearwater, Douglas, Hubbard, Lac
Qui Parle, Lake of the Woods, Pope, Stevens, Swift, and Yellow
Medicine Counties, and the White Earth Tribal Nation for Public
Assistance.

The following Catalog of Federal Domestic Assistance (CFDA) Numbers
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

Nancy Ward,
Acting Administrator, Federal Emergency Management Agency.
[FR Doc. E9-10082 Filed 4-30-09; 8:45 am]

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[Federal Register Volume 78, Number 216 (Thursday, November 7, 2013)]
[Notices]
[Pages 66987-66988]
[FR Doc No: 2013-26652]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2010-005-N-5]

Railroad Safety Technology Program Grant Program

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).

ACTION: Notice of funds availability, solicitation of applications.

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SUMMARY: The Railroad Safety Technology Grant Program was first
authorized under the Rail Safety Improvement Act of 2008 (RSIA). The
program authorizes DOT to provide grants to passenger and freight rail
carriers, railroad suppliers, and State and local governments for
projects that have a public benefit of improved railroad safety and
efficiency. The program originally made available $50 million in
Federal funds. Due to the original grantees completing their grants,
$550,000 became available from the original $50 million. This grant
program has a maximum 80-percent Federal and minimum 20-percent grantee
cost share (cash or in-kind) match requirement.

DATES: FRA will accept grant applications until February 5, 2014.
Reviews will be conducted immediately following the solicitation close
date. Selection announcements will be made 90 days after the
solicitation closes.

ADDRESSES: Applications for grants under this program must be submitted
electronically to Grants.gov (http://www.grants.gov) and must follow
the detailed procedures in the grant application package online. The
Grants.gov Web site allows organizations to find and electronically
apply for competitive grant opportunities from all Federal grantmaking
agencies. Any entity wishing to submit an application pursuant to this
notice should immediately initiate the process of registering with
Grants.Gov. Only grants submitted electronically through Grants.gov
will be considered.

FOR FURTHER INFORMATION CONTACT: Dr. Mark Hartong, Scientific and
Technical Advisor, FRA, at<PHONE_NUMBER> or<EMAIL_ADDRESS>or
Mr. David Blackmore, Program Manager-Advanced Technologies, FRA, at
(312) 835-3903 or<EMAIL_ADDRESS>to discuss the prospective
idea, its potential responsiveness to the solicitation, and potential
for FRA interest. Taking this action could forestall costly efforts by
interested parties whose proposed work may not be of interest to FRA
under this grant. Nontechnical inquiries should be directed to Ms.
Jennifer Capps, Grants Officer, at<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    Authority and Funding: The Railroad Safety Technology Grant
Program, authorized under Section 105 of the RSIA (Division A, Pub. L.
110-432) (49 U.S.C. 20158), allows for the appropriation of $50 million
annually for fiscal years 2009 through 2013. The Transportation,
Housing and Urban Development, and Related Agencies Appropriations Act
of 2010 provided $50 million for this purpose. Due to the original
grantees completing their grants, $550,000 became available from the
original $50 million.
    Eligible Organizations: Title 49 U.S.C. 20158 provides that
``Grants shall be made under this section to eligible passenger and
freight railroad carriers, railroad suppliers, and State and local
governments for projects . . . that have a public benefit of improved
safety and network efficiency.'' To be eligible for assistance,
entities must have either received approval of the Technology
Implementation Plans (TIP) and Positive Train Control (PTC)
Implementation Plans (PTCIP) required by 49 U.S.C. 20156(e)(2) and
20157, or demonstrate to the satisfaction of FRA that they are
currently developing the required plans where applicable. Preference
will be given in the following order:
    1. Entities that have completed and received FRA approval of both
their TIP and PTCIP.
    2. Entities that have completed and received FRA approval of their
PTCIP.
    3. Entities that have submitted their PTCIP to FRA for approval.
    4. Entities that have certified to FRA progress towards completion
of their PTCIP and TIP.
    5. All other entities.
    Collaborative project submissions by freight and passenger
carriers, suppliers, and State and local governments on eligible
projects will be evaluated more favorably.
    Eligible Projects: Grant awards will focus on using technologies or
methods that are ready for deployment or that are of sufficient
technical maturity that they can be made ready for deployment within 24
months of the award. FRA will give preference to collaborative projects
by multiple railroads that have active railroad carrier and sponsoring
public authority participation in the following order:
    Projects that:

    1. Facilitate sharing of PTC communications infrastructure and
spectrum.
    2. Support the resolution of PTC system interoperability issues.
    3. Optimize PTC deployment on the core 2015 PTC territory.
    4. All other projects.
    Selection Criteria: Applications will be evaluated and ranked based
on both technical and cost or price factors.
    A. Technical Factors (75% overall weighting):
    1. Responsiveness to Solicitation Intent and Requirements (20%):
Degree to which proposal meets the conceptual intent and submission
requirements of the solicitation.
    2. Significance for Implementing Interoperable PTC Deployment and
Fit with FRA's Mission (30%): Degree to which successful implementation
of proposed idea would make interoperable PTC deployment more
technically or economically practical--includes contribution to cost
effectiveness, reliability, safety, availability, or maintainability,
and fit within FRA primary mission ensuring the safety of the Nation's
approximately 700 railroads.
    3. Technical Merit (20%): Degree to which proposed ideas exhibit a
sound scientific and engineering basis; how well the proposed ideas
could be practically applied in, and would b]e compatible with, the
railroad environment; and perceived likelihood of technical and
practical success.
    4. Key Personnel and Supporting Organization (15%): The technical
qualifications and demonstrated experience of key personnel proposed to
lead and perform the technical efforts, and qualifications of primary
and supporting organizations to fully and successfully execute proposal
plan within proposed timeframe and budget.
    5. Collaborative Effort (15%): The degree to which proposed effort
is supported by multiple entities and the applicability and
availability of results to the larger railroad industry.
    B. Cost/Price Factor (25% overall weighting):
    1. Affordability and degree to which proposed effort appears to be
a good value for the amount of funding requested. The reasonableness
and realism of the proposed costs (60%).
    2. The extent of proposed cost sharing or cost participation under
the proposed effort (exclusive of the applicant's prior investment)
(40%).
    All evaluation factors, other than cost or price, when combined,
are significantly more important than cost or price alone. Technical
evaluation is appreciably more important than cost or price and, as
such, greater consideration will be given to technical excellence
rather than cost or price alone. An offer must be found acceptable
under all applicable evaluation factors to be considered eligible for
award. Awards will be made to responsible applicants whose offers
provide the best value to the Government in terms of technical
excellence, cost or price, and performance risk to include consistency
and accord with the objectives of the solicitation and FRA's expressed
areas of interest.
    Requirements and Conditions for Grant Applications: Detailed
application requirements and conditions may be found in the grant
application guidance, FR-RSTG-13-001, or this solicitation on
Grants.gov. Applications that do not meet the page-count requirements
specified in the grant application guidance will not be considered.
    Information Collection: The Office of Management and Budget (OMB)
has approved the information collection associated with the Railroad
Safety Technology Grant Program. The approval number for this
collection of information is OMB No. 2130-0587.

    Issued in Washington, DC, on November 4, 2013.
Robert C. Lauby,
Associate Administrator for Railroad Safety, Chief Safety Officer.
[FR Doc. 2013-26652 Filed 11-6-13; 8:45 am]
BILLING CODE 4910-06-P