[Federal Register Volume 84, Number 64 (Wednesday, April 3, 2019)]
[Proposed Rules]
[Pages 12969-12975]
[FR Doc No: 2019-06436]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 15

[Docket No. FDA-2019-N-1482]

Scientific Data and Information About Products Containing
Cannabis or Cannabis-Derived Compounds; Public Hearing; Request for
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public hearing; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing a public hearing to obtain scientific data and information
about the safety, manufacturing, product quality, marketing, labeling,
and sale of products containing cannabis or cannabis-derived compounds.

DATES: The public hearing will be held on May 31, 2019, from 8 a.m. to
6 p.m. Submit requests to make oral presentations and comments at the
public hearing by May 10, 2019. Electronic or written comments will be
accepted until July 2, 2019. See the SUPPLEMENTARY INFORMATION section
for registration and information.

ADDRESSES: The public hearing will be held at FDA White Oak
Campus,10903 New Hampshire Ave., Building 31 Conference Center, the
Great Room (Rm. 1503), Silver Spring, MD 20993. Entrance for the public
hearing participants (non-FDA employees) is through Building 1, where
routine security check procedures will be performed. For parking and
security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    FDA is establishing a docket for public comment on this hearing.
The docket number is FDA-2019-N-1482. The docket will close on July 2,
2019. Submit either electronic or written comments on this public
hearing by July 2, 2019. Please note that late, untimely filed comments
will not be considered. Electronic comments must be submitted on or
before July 2, 2019. The https://www.regulations.gov electronic filing
system will accept comments until 11:59 p.m. Eastern Time at the end of
July 2, 2019. Comments received by mail/hand delivery/courier (for
written/paper submissions) will be considered timely if they are
postmarked or the delivery service acceptance receipt is on or before
that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-N-1482 for ``Scientific Data and Information about Products
Containing Cannabis or Cannabis-Derived Compounds; Public Hearing;
Request for Comments.'' Received comments, those filed in a timely
manner (see ADDRESSES), will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
our consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked

as ``confidential'' will not be disclosed except in accordance with 21
CFR 10.20 and other applicable disclosure law. For more information
about FDA's posting of comments to public dockets, see 80 FR 56469,
September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beth F. Fritsch, Food and Drug
Administration, 10903 New Hampshire Ave. Bldg. 32, Rm. 5308, Silver
Spring, MD 20993,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background and Purpose of Hearing

    Cannabis is a plant of the Cannabaceae family and contains more
than 80 biologically active chemical compounds. The most commonly known
compounds are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD).
Parts of the Cannabis sativa plant have been controlled under the
Federal Controlled Substances Act (CSA) since 1970 under the drug class
``Marihuana'' (21 U.S.C. 802(16).\1\ ``Marihuana'' is listed in
Schedule I of the CSA due to its high potential for abuse, which is
attributable in large part to the psychoactive effects of THC, and the
absence of a currently accepted medical use for marijuana in the United
States. Cannabis and cannabis-derived products have been the subject of
increasing interest by consumers, industry, researchers, the public,
and regulators. Regulatory oversight of products containing cannabis or
cannabis-derived compounds is complex and involves multiple Federal and
State agencies.
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    \1\ Under the CSA, the term ``marihuana'' means all parts of the
plant Cannabis sativa L., whether growing or not; the seeds thereof;
the resin extracted from any part of such plant; and every compound,
manufacture, salt, derivative, mixture, or preparation of such
plant, its seeds or resin. Such a term does not include hemp or the
mature stalks of such plant, fiber produced from such stalks, oil or
cake made from the seeds of such plant, any other compound,
manufacture, salt, derivative, mixture, or preparation of such
mature stalks (except the resin extracted therefrom), fiber, oil, or
cake, or the sterilized seed of such plant which is incapable of
germination.
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    The legality of cannabis has been changing over time at both the
State and Federal levels. Currently, 33 States and Washington, DC,
allow ``medical'' use of marijuana under State law and 14 additional
States have State law ``medical'' programs that are limited to CBD
products. In addition, 10 States and Washington, DC, have legalized
marijuana for recreational use under State law, and 13 additional
States have decriminalized recreational marijuana possession under
State law in some form.
    At the Federal level, the Agriculture Improvement Act of 2018,
Public Law 115-334 (the 2018 Farm Bill), was signed into law on
December 20, 2018. Among other things, this new law changes certain
Federal authorities relating to the production and marketing of hemp,
defined as the plant Cannabis sativa L. and any part of that plant,
including the seeds thereof and all derivatives, extracts,
cannabinoids, isomers, acids, salts, and salts of isomers, whether
growing or not, with a delta-9 tetrahydrocannabinol concentration of
not more than 0.3 percent on a dry weight basis. These changes include
removing hemp from the CSA, which means that cannabis plants and
derivatives that contain no more than 0.3 percent THC on a dry weight
basis are no longer controlled substances under Federal law.
    The 2018 Farm Bill explicitly preserved FDA's authority to regulate
products containing cannabis or cannabis-derived compounds under the
Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the
Public Health Service Act.\2\ In doing so, Congress recognized FDA's
important public health role with respect to all the products it
regulates. Therefore, because the 2018 Farm Bill did not change FDA's
authorities, cannabis and cannabis-derived products are subject to the
same authorities and requirements as FDA-regulated products containing
any other substance, regardless of whether the products fall within the
definition of ``hemp'' under the 2018 Farm Bill.
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    \2\ For a discussion of FDA's legal authorities, see section IV
of this notice.
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    FDA is aware that some companies are marketing products containing
cannabis and cannabis-derived compounds in ways that violate the FD&C
Act. FDA has taken action against companies illegally selling cannabis
and cannabis-derived products that put the health and safety of
consumers at risk. For example, FDA has issued warning letters \3\ to
companies illegally selling CBD products that were intended to prevent,
diagnose, mitigate, treat, or cure serious diseases, such as cancer,
and that had not obtained new drug approvals. Selling unapproved drug
products with unsubstantiated therapeutic claims is not only a
violation of the law, but also can put patients at risk as the
marketing of unproven treatments raises significant public health
concerns. Patients and other consumers may be influenced not to use
approved therapies to treat serious and even fatal diseases.
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    \3\ https://www.fda.gov/NewsEvents/PublicHealthFocus/ucm484109.htm.
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    FDA's warning letters also cited food products to which CBD had
been added and CBD products marketed as dietary supplements. As
discussed below, under current law, such products violate the FD&C Act
because CBD is an active ingredient in an approved drug and has been
the subject of substantial clinical investigations. Allowing drug
ingredients in foods can undermine the drug approval process and
diminish commercial incentives for further clinical study of the
relevant drug substance. It also raises questions about the safety to
consumers of exposure from broader consumption of such ingredients.
    While the use of cannabis and cannabis-derived products, including
hemp and hemp-derived products, has increased dramatically in recent
years, questions remain regarding the safety considerations raised by
the widespread use of these products. These questions could impact the
approaches we consider taking in regulating the development and
marketing of products. For example, a 2017 report by the National
Academies of Sciences, Engineering, and Medicine \4\ reviewed the
scientific literature published since 1999 about what is known about
the health impacts of cannabis and cannabis-derived products and
identified the need for additional research. In addition, during its
review of the marketing application for EPIDIOLEX, a CBD oral solution
indicated for the treatment of seizures associated with Lennox-Gastaut
syndrome and Dravet syndrome in patients 2 years of age and older that
was approved in 2018, FDA identified certain safety concerns (see FDA's
drug approval package at: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm). Specifically, at
doses of 20

milligrams per kilogram of body weight per day (mg/kg/day) of EPIDIOLEX
in clinical trials, there was a potential for liver injury, evidenced
by elevated transaminase levels. This is a potentially serious risk
that can be managed when the product is taken under medical supervision
in accordance with the FDA approved labeling for the product, but it is
less clear how this risk might be managed if this substance is used far
more widely, without medical supervision, and not in accordance with
FDA-approved labeling. Other serious treatment-emergent adverse events
reported in clinical studies of EPIDIOLEX included somnolence and
lethargy; and hypersensitivity reactions. Common adverse reactions
included decreased appetite, diarrhea, and sleep disorders.
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    \4\ http://www.nationalacademies.org/hmd/Reports/2017/health-effects-of-cannabis-and-cannabinoids.aspx.
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    Given the substantial interest in this topic and Congressional
interest in fostering the development of appropriate hemp products
under the 2018 Farm Bill, while also preserving FDA's ability to
protect the public health, FDA is holding a public hearing. The goal of
the hearing is to obtain additional scientific data and other
information related to cannabis and cannabis-derived compounds, both
from botanical and synthetic sources, to inform our regulatory
oversight of these products. FDA does not intend for this hearing to
produce any decisions or new positions on specific regulatory
questions, but this hearing is expected to be an important step in our
continued evaluation of cannabis and cannabis-derived compounds in FDA-
regulated products.

II. Participating in the Public Hearing

    Registration: To register to attend the public hearing, either in
person or by webcast, on ``Scientific Data and Information about
Products Containing Cannabis or Cannabis-Derived Compounds'' please
register at https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm634550.htm. Please provide complete
contact information for each attendee, including name, title,
affiliation, address, email, and telephone and whether you want to
attend in person or by webcast.
    Request for Presentations: During online registration, you may
indicate if you wish to make a formal presentation (with accompanying
slide deck) or present oral comments during the public hearing session
(with no slide deck) and which topic(s) you would like to address. FDA
will do its best to accommodate requests to make public presentations.
We are seeking to have a broad representation of ideas and issues
presented at the meeting. Individuals and organizations with common
interests are urged to consolidate or coordinate their presentations.
Following the close of registration, FDA will determine the amount of
time allotted to each presenter and the approximate time each
presentation is to begin and will select and notify participants by May
21, 2019. All requests to make presentations must be received by the
close of registration on May 10, 2019, Eastern Time.
    If selected for a formal oral presentation (with a slide deck),
each presenter must submit an electronic copy of their presentation
(PowerPoint or PDF) to [email protected] with the
subject line ``Scientific Data and Information about Products
Containing Cannabis or Cannabis-Derived Compounds'' on or before May
28, 2019. No commercial or promotional material will be permitted to be
presented or distributed at the public hearing.
    Persons notified that they will be presenters are encouraged to
arrive at the hearing room early and check in at the onsite
registration table to confirm their designated presentation time.
Actual presentation times may vary based on how the meeting progresses
in real time. An agenda for the hearing and any other background
materials will be made available 5 days before the hearing at https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm634550.htm.
    Those without internet or email access can register and/or request
to participate by contacting Beth F. Fritsch by the above dates (see
FOR FURTHER INFORMATION CONTACT).
    Streaming Webcast of the Public Hearing: For those unable to attend
in person, FDA will provide a live webcast of the hearing. To join the
hearing via the webcast, please go to https://collaboration.fda.gov/cannabispart15.
    Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm634550.htm. It may be viewed at the
Dockets Management Staff (see ADDRESSES) and also will be available at
https://www.regulations.gov.

III. Issues for Consideration and Request for Data and Information

    We encourage public comments and presentations at the public
hearing. In submitting comments, data, and information to the docket,
please identify available references for the data and information, as
well as the general category area and specific question number listed
below.

A. Health and Safety Risks

    As noted above, there are many unanswered questions about the
safety of cannabis and cannabis-derived products. To inform FDA's
regulatory oversight of these products, especially as we consider
whether it is appropriate to exercise our authority to allow the use of
CBD in dietary supplements and other foods, we are interested in
obtaining information, including data and studies, on, among other
things:
    1. Based on what is known about the safety of products containing
cannabis and cannabis-derived compounds, are there particular safety
concerns that FDA should consider regarding its regulatory oversight
and monitoring of these products? For example:
     What levels of cannabis and cannabis-derived compounds
cause safety concerns?
     How does the mode of delivery (e.g., ingestion,
absorption, inhalation) affect the safety and exposure to cannabis and
cannabis-derived compounds?
     How do cannabis and cannabis-derived compounds interact
with other substances (e.g., drug ingredients)?
    2. Are there special human populations (e.g., children,
adolescents, pregnant and lactating women) or animal populations (e.g.
species, breed, or class) that should be considered when assessing the
safety of products containing cannabis and cannabis-derived compounds?
    3. What are the characteristics of a successful system to collect
representative safety information at the national or State level about
products containing cannabis and cannabis-derived compounds?
     Are there systems that currently exist for the collection
of this information (other than FDA's systems)?
     Are there particular safety concerns related to the
overlap of therapeutic dose levels from approved drug products, with
potential exposure from other uses (e.g., from food, dietary
supplements, cosmetics)? Please identify any safety concerns and
include relevant data or studies.
    4. What endpoints or outcomes would define a maximal acceptable
daily intake from all products?
     What margin of exposure would represent an appropriate and
safe level from anticipated cumulative exposure? Does that margin of
exposure vary based on the form of consumption (e.g., from ingestion,
absorption, inhalation)? Please explain your reasoning and include
relevant data or studies.

     What mechanisms would be available to help ensure that
this margin of exposure was maintained at a level sufficiently
protective of public health?
    5. Are there any data known that would support the safe use of
cannabis and cannabis-related compounds in general food use (including
dietary supplements), including data regarding exposure levels to
cannabis and cannabis-related compounds in foods (including dietary
supplements) that would be acceptable from a food safety perspective?
     What data are available about residues of cannabis-derived
compounds in human foods (e.g., meat, milk, or eggs) that come from
animals that consume cannabis or cannabis-derived compounds? Are there
residue levels that should be tolerated in these foods? Please provide
data or other information to support your reasoning.
    6. How does the existing commercial availability of food products
containing cannabis-derived compounds such as CBD (which may in some
cases be lawful at the State level but not the Federal level) affect
the incentives for, and the feasibility of, drug-development programs
involving such compounds?
     How would the incentives for, and the feasibility of, drug
development be affected if food products containing cannabis-derived
compounds, such as CBD, were to become widely commercially available?
How would this change if FDA established thresholds on acceptable
levels of cannabinoids, including CBD, in the non-drug products it
regulates? What else could FDA do to support drug development from
cannabinoids?

B. Manufacturing and Product Quality

    Please provide data and information on how products containing
cannabis or cannabis-derived compounds (other than those marketed as
drugs in compliance with the FD&C Act) are currently manufactured,
including information about methods for ensuring product quality and
consistency. More specifically, we are interested in obtaining
information on, among other things:
    1. Are there particular standards needed to address any safety
issues related to the manufacturing, processing, and holding of
products containing cannabis and cannabis-derived compounds (e.g.,
genotoxic impurities, degradation of active compounds)? Please identify
or describe those standards.
    2. Are there particular standards or processes needed to ensure
manufacturing quality and consistency of products containing cannabis
or cannabis-derived compounds, including standards applied to evaluate
product quality? Please identify or describe those standards.
    3. What validated analytical testing is needed to support the
manufacturing of safe and consistent products?
    4. Are there any currently used standardized definitions for the
ingredients in cannabis products (e.g., ``hemp oil'')? If standardized
definitions would be helpful, what terms should be defined and what
should the definition(s) be?
    5. What are the functional purposes of adding cannabis-derived
compounds, such as CBD, to foods (e.g., nutritive value, technical
effect), both in terms of manufacturer intent and consumer perceptions
and/or expectations? To the extent a compound is added to food to
achieve a particular functional purpose, what evidentiary support is
available to demonstrate that the addition of such compound has the
intended or perceived effect?

C. Marketing/Labeling/Sales

    FDA is interested in information about how products containing
cannabis or cannabis-derived compounds, other than drug products
approved by FDA for human or animal use, are marketed, labeled, and
sold. More specifically, we seek information on, among other things:
    1. How should consumers be informed about the risks associated with
such products (e.g., directions for use, warnings)? What specific risks
should consumers be informed about? Are there any subpopulations for
which additional warnings or restrictions are appropriate? Please
explain your reasoning.
    2. What conditions, restrictions, or other limitations on the
manufacturing and distribution of these products have been put in place
under State or local law, particularly with respect to food products
containing cannabis-derived compounds such as CBD (which may, in some
cases, be lawful at the State level but not the Federal level)? What
other conditions, restrictions, or other limitations might be
appropriate to ensure adequate consumer information and to protect the
public health?
    3. What statutory or regulatory restrictions are in place under
State or local law to warn about the use of these products by certain
vulnerable human populations (e.g., children, adolescents, pregnant and
lactating women) or animal populations (e.g. species, breed, or class)?
Are there other steps that should be taken to warn about use by
vulnerable populations? Please identify such steps and how they would
apply to a particular subpopulation.
    4. What other information should FDA consider in the labeling of
specific product categories of cannabis and cannabis-derived products?

IV. FDA Legal Authorities

    There are FD&C Act provisions that are relevant to the legality of
cannabis or cannabis-derived products. To help in understanding the
context of the public hearing and current FDA actions, a synopsis of
FDA legal authorities is provided below.

A. Human Drugs

    A drug is an article intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of disease in man or other animals
(section 201(g) of the FD&C Act (21 U.S.C. 321(g)). A drug is also
defined as an article (other than food) intended to affect the
structure or any function of the body of man or other animals. Thus,
the determination of whether a product is a drug turns in part on the
``intended use'' of the product.
    By statute, it is a prohibited act to introduce a new drug into
interstate commerce unless it has an approved marketing application
(New Drug Application (NDA) or Abbreviated New Drug Application (ANDA))
(section 301(d) of the FD&C Act (21 U.S.C. 331(d)). FDA reviews the
data submitted in a marketing application to evaluate whether a drug
product meets the statutory standards for approval. To conduct clinical
research that can lead to an approved new drug, including research
using materials from plants such as cannabis, researchers submit an
Investigational New Drug (IND) application to FDA, as described in 21
CFR part 312.
    FDA has approved several drug products that contain compounds found
in cannabis. Most recently, FDA has approved EPIDIOLEX,\5\ which
contains the purified drug substance CBD for the treatment of seizures
associated with Lennox-Gastaut syndrome or Dravet syndrome in patients
2 years of age and older. We also have approved MARINOL and SYNDROS for
therapeutic uses in the United States, including for the treatment of
anorexia associated with weight loss in AIDS patients. MARINOL and
SYNDROS include the active ingredient dronabinol, a synthetic THC which
is considered the psychoactive component of marijuana. Another FDA-
approved drug, CESAMET, contains the active ingredient nabilone, which
has a

chemical structure similar to THC and is synthetically derived.
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    \5\ https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/210365Orig1s000TOC.cfm.
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B. Human Foods/Dietary Supplements

    By statute, any substance intentionally added to food is a food
additive, and therefore subject to premarket review and approval by
FDA, unless the substance is generally recognized as safe (GRAS) by
qualified experts under the conditions of its intended use, or the use
of the substance is otherwise excepted from the definition of a food
additive (sections 201(s) and 409 of the FD&C Act (21 U.S.C. 321(s) and
348)). Three hemp seed ingredients--hulled hemp seeds, hemp seed
protein, and hemp seed oil--have gone through the FDA GRAS process and
can be legally marketed in human foods for certain uses without food
additive approval, provided they comply with all other requirements.
More specifically, these three ingredients were the subject of a GRAS
notice in which the submitter concluded that the ingredients were GRAS
for specific uses in human foods. FDA evaluated these notices and had
no questions \6\ regarding the submitter's conclusions.
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    \6\ https://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm628910.htm.
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    No other cannabis-derived compounds have been the subject of a food
additive petition, an evaluated GRAS petition, or have otherwise been
approved for use in food by FDA. Food companies that wish to use
cannabis or cannabis-derived compounds in their foods are subject to
the relevant laws and regulations that relate to the food additive \7\
and GRAS \8\ processes.
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    \7\ https://www.fda.gov/Food/IngredientsPackagingLabeling/FoodAdditivesIngredients/default.htm.
    \8\ https://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/.
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    In addition, it is prohibited by statute to introduce or deliver
for introduction into interstate commerce any food (including any
animal food) to which has been added a substance which is an active
ingredient in a drug product approved under section 505 of the FD&C Act
(21 U.S.C. 355) or a drug for which substantial clinical investigations
have been instituted and for which the existence of such investigations
has been made public (section 301(ll) of the FD&C Act (21 U.S.C.
331(ll)). There are exceptions, including when the drug was marketed in
food before the drug was approved or before the substantial clinical
investigations involving the drug had been instituted or, in the case
of animal food, that the drug is a new animal drug approved for use in
animal food and used according to the approved labeling. Based on
available evidence, FDA has concluded \9\ that it is a prohibited act
to introduce or deliver for introduction into interstate commerce any
food (including any animal food) to which THC or CBD has been added.
When this statutory prohibition applies to a substance, the substance
cannot be added to any food that is sold into interstate commerce
unless the Secretary of the Department of Health and Human Services
(the Secretary),\10\ in the Secretary's discretion, has issued a
regulation approving the use of the substance in the food (section
301(ll)(2) of the FD&C Act. To date, no such regulation has been issued
for any substance.
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    \9\ https://www.fda.gov/newsevents/publichealthfocus/ucm421168.htm#legal.
    \10\ The authority to make this determination has been delegated
to FDA.
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    For similar reasons, FDA has determined that products that contain
THC or CBD cannot be marketed as dietary supplements.\11\ By statute,
if an ingredient is approved as a new drug under section 505 of the
FD&C Act or has been authorized for investigation as a new drug for
which substantial clinical investigations have been instituted and for
which the existence of such investigations has been made public, then
products containing that substance are excluded from the statutory
definition of a dietary supplement (sections 201(ff)(3)(B)(i) and (ii)
of the FD&C Act. There is an exception if the substance was ``marketed
as'' a dietary supplement or as a food before the new drug
investigations were authorized. Based on available evidence, FDA has
concluded that this is not the case for THC or CBD. There is also an
exception if FDA has issued a regulation finding that the article would
be lawful under the FD&C Act (section 201(ff)(3)(B) of the FD&C Act).
At this time, no such regulation has been issued.
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    \11\ https://www.fda.gov/newsevents/publichealthfocus/ucm421168.htm#dietary_supplements.
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    Some ingredients are derived from parts of the cannabis plant that
may not contain THC or CBD, in which case those ingredients might fall
outside the scope of this exclusion, and therefore might be able to be
marketed as dietary supplements. However, the product must still comply
with all other applicable laws and regulations governing dietary
supplement products. For example, manufacturers and distributors who
wish to market dietary supplements that contain ``new dietary
ingredients'' (i.e., dietary ingredients that were not marketed in the
United States in a dietary supplement before October 15, 1994)
generally must notify FDA \12\ about these ingredients (section 413(d)
of the FD&C Act (21 U.S.C. 350b(d)). Generally, the notification must
include information demonstrating that a dietary supplement containing
a new dietary ingredient will reasonably be expected to be safe under
the conditions of use recommended or suggested in the labeling. A
dietary supplement is adulterated if it contains a new dietary
ingredient for which there is inadequate information to provide
reasonable assurance that the ingredient does not present a significant
or unreasonable risk of illness or injury (section 402(f)(1)(B) of the
FD&C Act (21 U.S.C. 342(f)(1)(B)).
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    \12\ https://www.fda.gov/Food/DietarySupplements/NewDietaryIngredientsNotificationProcess/ucm109764.htm.
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    Numerous other legal requirements apply to food and dietary
supplement products, including requirements relating to CGMPs,
labeling, allergens, and various provisions of the FDA Food Safety
Modernization Act. Information about these requirements, and about FDA
requirements across all product areas, can be found on FDA's website,
https://www.fda.gov.

C. Animal Food and Drugs

    FDA regulates animal food in a variety of ways, including by
approving safe food additives and establishing standards for animal
food contaminants. FDA has not reviewed any food additive petitions for
cannabis-derived animal feed, nor have any cannabis-derived feed
ingredients been the subject of a GRAS determination by FDA, a GRAS
notice that underwent FDA evaluation and received a ``no questions''
response, or otherwise been approved for use in animal feed by FDA.
Animal food companies that wish to use cannabis or cannabis-derived
compounds in their animal food products are subject to the relevant
laws and regulations that relate to the food additive and GRAS
processes. With respect to THC and CBD specifically, as discussed
above, it is a prohibited act under section 301(ll) of the FD&C Act, to
introduce or deliver for introduction into interstate commerce any
animal food to which THC or CBD has been added.
    As stated above, a drug is an article intended for use in the
diagnosis, cure, mitigation, treatment, or prevention of disease in man
or other animals (section 201(g) of the FD&C Act. A drug is also
defined as an article (other than food) intended to affect the
structure or any function of the body of man or other animals. Thus,
the determination of whether a product is a drug turns in part on the
``intended use'' of the product.

    Currently, there are no legally marketed new animal drugs that
contain cannabis or cannabis-derived compounds. A new animal drug is
deemed ``unsafe'' under section 512(a) of the FD&C Act (21 U.S.C.
360b(a)), and may not be sold into interstate commerce under section
301(a) of the FD&C Act), unless it has an approved new animal drug
application (NADA), abbreviated NADA (ANADA), conditional approval
(CNADA) or index listing. FDA reviews the data submitted in a marketing
application to evaluate whether an animal drug product meets the
statutory standards for approval. To conduct clinical research that can
lead to an approved new animal drug, including research using materials
from plants such as cannabis, researchers establish an Investigational
New Animal Drug (INAD) file with FDA, and comply with the requirements
described in 21 CFR part 511.

D. Cosmetics

    Under the FD&C Act, cosmetic products and ingredients are not
subject to premarket approval by FDA, except for most color additives.
Certain cosmetic ingredients are prohibited or restricted by
regulation,\13\ but currently that is not the case for any cannabis or
cannabis-derived ingredients. Ingredients not specifically addressed by
regulation must nonetheless comply with all applicable requirements,
and no ingredient--including a cannabis or cannabis-derived
ingredient--can be used in a cosmetic if it causes the product to be
adulterated or misbranded in any way. A cosmetic generally is
adulterated if it bears or contains any poisonous or deleterious
substance which may render it injurious to users under the conditions
of use prescribed in the labeling, or under such conditions of use as
are customary or usual (section 601(a) of the FD&C Act (21 U.S.C.
361(a)).
---------------------------------------------------------------------------

    \13\ https://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm127406.htm.
---------------------------------------------------------------------------

E. Tobacco Products

    The Family Smoking Prevention and Tobacco Control Act (Tobacco
Control Act) (Pub. L. 111-31) was enacted on June 22, 2009, amending
the FD&C Act and providing FDA with the authority to regulate tobacco
products. Specifically, the Tobacco Control Act amends the FD&C Act by
adding a new chapter that provides FDA with authority over tobacco
products. Section 901(b) of the FD&C Act (21 U.S.C. 387a(b)), as
amended by the Tobacco Control Act, states that the new chapter in the
FD&C Act (chapter IX--Tobacco Products) (21 U.S.C. 387 through 387u)
applies to all cigarettes, cigarette tobacco, roll-your-own tobacco,
smokeless tobacco, and any other tobacco products that the Secretary by
regulation deems to be subject to chapter IX. In the Federal Register
of May 10, 2016 (81 FR 28973), FDA issued a final rule deeming all
products that meet the statutory definition of ``tobacco product'' in
section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)), except accessories
of deemed tobacco products, to be subject to FDA's tobacco product
authority (the deeming rule). The products now subject to FDA's tobacco
product authority include electronic nicotine delivery systems
(sometimes referred to as vapes, vaporizers, or electronic cigarettes,
among other terms), cigars, waterpipes (hookah), pipe tobacco, nicotine
gels, dissolvables that were not already subject to the FD&C Act, and
other tobacco products that meet the statutory definition of ``tobacco
product'' (other than accessories) that may be developed in the future.
The term ``tobacco product'' means any product made or derived from
tobacco that is intended for human consumption, including any
component, part, or accessory of a tobacco product (except for raw
materials other than tobacco used in manufacturing a component, part,
or accessory of a tobacco product) (section 201(rr)(1) of the FD&C Act.
For example, an e-liquid mixture that contains both a cannabis-derived
ingredient and nicotine made or derived from tobacco, and that is
intended for human consumption, would likely be subject to FDA's
chapter IX authorities.
    Numerous legal requirements apply to tobacco products, including
legal requirements that relate to new tobacco products that are to be
introduced, or delivered for introduction into interstate commerce.
Other requirements relate to registration and listing, and sales and
distribution, among other things. For more information on these topics,
including the statutory standards that must be met for FDA to permit
new tobacco products to be marketed, we encourage interested parties to
go to the Center for Tobacco Products' web page at https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm246129.htm.

F. Medical Devices

    An article is a device if it is an instrument, apparatus,
implement, machine, contrivance, implant, in vitro reagent, or other
similar related article which is intended for use in the diagnosis of
disease or other conditions, or in the cure mitigation, treatment, or
prevention of disease, or is intended to affect the structure or any
function of the body of man (section 201(h) of the FD&C Act). A device
is also defined as not achieving its primary intended purposes through
chemical action in or on the body of man and which is not dependent
upon being metabolized for the achievement of its primary intended
purpose (Id.). For example, an article that is used to aid intake of a
product that contains cannabis or a cannabis-derived compound could be
properly classified as a device if it meets all aspects of the above
definition.
    The FD&C Act establishes a comprehensive system for the regulation
of medical devices intended for human use. The FD&C Act categorizes
medical devices into one of three classes based on their risks and the
extent of the regulatory controls needed to provide reasonable
assurance of their safety and effectiveness (see section 513 of the
FD&C Act (21 U.S.C. 360c)). The three categories of devices are class I
(general controls), class II (special controls), and class III
(premarket approval). Class I devices generally pose the lowest risk to
the patient and/or user and class III devices pose the highest risk.
    The class to which a device is assigned determines, among other
things, the type of premarket submission required for FDA authorization
to market. In general, if a device is classified as class I or II, and
if it is not exempt, manufacturers must obtain FDA clearance of a
premarket notification (also referred to as a 510(k) submission) (see
sections 510(k) and 513(i) of the FD&C Act (21 U.S.C. 360(k) and
360c(i))). For class III devices, manufacturers generally must obtain
FDA approval of a premarket approval application (PMA) (see section 515
of the FD&C Act (21 U.S.C. 360e)). It is a prohibited act to market a
device without its requisite premarket approval (see section 501(f)(1)
of the FD&C Act (21 U.S.C. 351)).

V. Notice of Hearing Under 21 CFR Part 15

    The Commissioner of Food and Drugs is announcing that this public
hearing will be held in accordance with part 15 (21 CFR part 15). The
hearing will be conducted by a presiding officer, who will be
accompanied by FDA senior management from relevant program areas. Under
Sec.  15.30(f), the hearing is informal and the rules of evidence do
not apply. No participant may interrupt the presentation of another
participant. Only the presiding officer and panel members can pose
questions; they can question any person during or at the

conclusion of each presentation. Public hearings under part 15 are
subject to FDA's policy and procedures for electronic media coverage of
FDA's public administrative proceedings (21 CFR part 10, subpart C).
    Under Sec.  10.205, representatives of the media may be permitted,
subject to certain limitations, to videotape, film, or otherwise record
FDA's public administrative proceedings, including presentations by
participants. Persons attending FDA's public hearings are advised that
FDA is not responsible for providing access to electrical outlets.
    The hearing will be transcribed as stipulated in Sec.  15.30(b)
(see Supplementary Information). To the extent that the conditions for
the hearing, as described in this notice, conflict with any provisions
set out in part 15, this notice acts as a waiver of those provisions as
specified in Sec.  15.30(h).

    Dated: March 28, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-06436 Filed 4-2-19; 8:45 am]
 BILLING CODE 4164-01-P


M2--Certain TOs, GOs and DPs               166               1  Reporting: 0.....  Reporting: 0.
 must have evidence that a                                      Recordkeeping: 10  Recordkeeping: 1,660.
 facility rating was agreed to
 by PA, TOP and RC.
M3--PC must document process                79               1  175..............  13,825.
 for determining critical
 facilities and (2) a current
 list of such facilities.
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  .................  60,485.
----------------------------------------------------------------------------------------------------------------

     Total Annual hours for Collection: (Reporting +
recordkeeping) = 60,485 hours. Information Collection Costs: The
Commission seeks comments on the costs to comply with these
requirements. It has projected the average annualized cost to be the
total annual hours.

Recordkeeping = 60,485 @ $40/hour = $--241,940 ---- .
Labor (file/record clerk @ $17 an hour + supervisory @ $23 an hour)

     Total costs = $--241,940 ---- .
     Title: FERC-725-G Mandatory Reliability Standard for
Transmission Relay Loadability.
     Action: Proposed Collection of Information.
     OMB Control No: [To be determined.]
     Respondents: Business or other for profit, and/or not for
profit institutions.
     Frequency of Responses: On Occasion
     Necessity of the Information: The Transmission Relay
Loadability Reliability Standard, if adopted, would implement the
Congressional mandate of the Energy Policy Act of 2005 to develop
mandatory and enforceable Reliability Standards to better ensure the
reliability of the nation's Bulk-Power System. Specifically, the
proposed Reliability Standard would ensure that protective relays are
set according to specific criteria to ensure that relays reliably
detect and protect the electric network from all fault conditions, but
do not limit transmission loadability or interfere with system
operator's ability to protect system reliability.
     Internal review: The Commission has reviewed the
requirements pertaining to the proposed Reliability Standard for the
Bulk-Power System and determined that the proposed requirements are
necessary to meet the statutory provisions of the Energy Policy Act of
2005. These requirements conform to the Commission's plan for efficient
information collection, communication and management within the energy
industry. The Commission has assured itself, by means of internal
review, that there is specific, objective support for the burden
estimates associated with the information requirements.
    114. Interested persons may obtain information on the reporting
requirements by contacting: Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426 [Attention: Michael Miller,
Office of the Executive Director, Phone:<PHONE_NUMBER>, fax: (202)
273-0873, e-mail<EMAIL_ADDRESS>Comments on the
requirements of the proposed rule may also be sent to the Office of
Information and Regulatory Affairs, Office of Management and Budget,
Washington, DC 20503 [Attention: Desk Officer for the Federal Energy
Regulatory Commission], e-mail<EMAIL_ADDRESS>
V. Environmental Analysis

    115. The Commission is required to prepare an Environmental
Assessment or an Environmental Impact Statement for any action that may
have a significant adverse effect on the human environment.\116\ The
Commission has categorically excluded certain actions from this
requirement as not having a significant effect on the human
environment. The actions proposed here fall within the categorical
exclusion in the Commission's regulations for rules that are
clarifying, corrective or procedural, for information gathering,
analysis, and dissemination.\117\ Accordingly, neither an environmental
impact statement nor environmental assessment is required.
---------------------------------------------------------------------------

    \116\ Order No. 486, Regulations Implementing the National
Environmental Policy Act, 52 FR 47,897 (Dec. 17, 1987), FERC Stats.
& Regs. ] 30,783 (1987).
    \117\ 18 CFR 380.4(a)(5) (2008).
---------------------------------------------------------------------------

VI. Regulatory Flexibility Act Analysis

    116. The Regulatory Flexibility Act of 1980 (RFA) \118\ generally
requires a description and analysis of final rules that will have
significant economic impact on a substantial number of small entities.
Most of the entities, i.e., transmission owners, generator owners,
distribution providers, and ``planning coordinators,'' or alternatively
``planning authorities,'' to which the requirements of this rule would
apply do not fall within the definition of small entities.\119\
---------------------------------------------------------------------------

    \118\ 5 U.S.C. 601-12.
    \119\ The RFA definition of ``small entity'' refers to the
definition provided in the Small Business Act (SBA), which defines a
``small business concern'' as a business that is independently owned
and operated and that is not dominant in its field of operation. See
15 U.S.C. 632 (2006). According to the SBA, a small electric utility
is defined as one that has a total electric output of less than four
million MWh in the preceding year.
---------------------------------------------------------------------------

    117. As indicated above, based on available information regarding
NERC's compliance registry, approximately 525 entities will be
responsible for compliance with the new Reliability Standard. The
Commission certifies that the proposed Reliability Standard will not
have a significant adverse impact on a substantial number of small
entities.
    118. Based on this understanding, the Commission certifies that
this rule will not have a significant economic impact on a substantial
number of small entities. Accordingly, no regulatory flexibility
analysis is required.

VII. Comment Procedures

    119. The Commission invites interested persons to submit comments
on the matters and issues proposed in this notice to be adopted,
including any related matters or alternative proposals that commenters
may wish to discuss. Comments are due July 27, 2009. Comments must
refer to Docket No. RM08-13-000, and must include the commenter's name,
the organization they represent, if applicable, and their address in
their comments.
    120. The Commission encourages comments to be filed electronically
via the eFiling link on the Commission's Web site at http://
www.ferc.gov. The Commission accepts most standard word processing
formats. Documents

created electronically using word processing software should be filed
in native applications or print-to-PDF format and not in a scanned
format. Commenters filing electronically do not need to make a paper
filing.
    121. Commenters that are not able to file comments electronically
must send an original and 14 copies of their comments to: Federal
Energy Regulatory Commission, Secretary of the Commission, 888 First
Street, NE., Washington, DC 20426.
    122. All comments will be placed in the Commission's public files
and may be viewed, printed, or downloaded remotely as described in the
Document Availability section below. Commenters on this proposal are
not required to serve copies of their comments on other commenters.

VIII. Document Availability

    123. In addition to publishing the full text of this document in
the Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
Internet through FERC's Home Page (http://www.ferc.gov) and in FERC's
Public Reference Room during normal business hours (8:30 a.m. to 5 p.m.
Eastern time) at 888 First Street, NE., Room 2A, Washington, DC 20426.
    124. From FERC's Home Page on the Internet, this information is
available on eLibrary. The full text of this document is available on
eLibrary in PDF and Microsoft Word format for viewing, printing, and/or
downloading. To access this document in eLibrary, type the docket
number excluding the last three digits of this document in the docket
number field.
    125. User assistance is available for eLibrary and the FERC's Web
site during normal business hours from FERC Online Support at 202-502-
6652 (toll free at 1-866-208-3676) or e-mail at
<EMAIL_ADDRESS>or the Public Reference Room at (202) 502-
8371, TTY<PHONE_NUMBER>. E-mail the Public Reference Room at
<EMAIL_ADDRESS>
List of Subjects in 18 CFR Part 40

    Electric power, Reporting and recordkeeping requirements.

    By direction of the Commission.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. E9-12350 Filed 5-27-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: October 24, 2007 (Volume 72, Number 205)]
[Rules and Regulations]
[Page 60227-60228]
[DOCID:fr24oc07-1]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.

========================================================================

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2007-28319; Directorate Identifier 2007-NE-27-AD;
Amendment 39-15243; AD 2007-22-07]
RIN 2120-AA64

Airworthiness Directives; General Electric Company (GE) CF6-
80C2D1F Turbofan Engines

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for GE
CF6-80C2D1F turbofan engines, installed on, but not limited to,
McDonnell Douglas Corporation MD-11 series airplanes. This AD requires
removing previous software versions from the engine electronic control
unit (ECU). Engines with new version software will have increased
margin to flameout. This AD results from reports of engine flameout
events during flight, including reports of events where all engines
simultaneously experienced a flameout or other adverse operation.
Although the root cause investigation is not yet complete, we believe
that exposure to ice crystals during flight is associated with these
flameout events. We are issuing this AD to minimize engine flameout
caused by ice accretion and shedding during flight.

DATES: This AD becomes effective November 28, 2007.

ADDRESSES: You can get the service information identified in this AD
from General Electric Company via Lockheed Martin Technology Services,
10525 Chester Road, Suite C, Cincinnati, Ohio 45215, telephone (513)
672-8400, fax<PHONE_NUMBER>.
    The Docket Operations office is located at U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: John Golinski, Aerospace Engineer,
Engine Certification Office, FAA, Engine and Propeller Directorate, 12
New England Executive Park, Burlington, MA 01803; e-mail:
<EMAIL_ADDRESS>telephone:<PHONE_NUMBER>, fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The FAA proposed to amend 14 CFR part 39
with a proposed AD. The proposed AD applies to GE CF6-80C2D1F turbofan
engines, installed on McDonnell Douglas Corporation MD-11 series
airplanes. We published the proposed AD in the Federal Register on July
17, 2007 (72 FR 39039). That action proposed to require removing
previous software versions from the engine ECU.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov
; or in person at the Docket Operations office

between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The street address for
the Docket Operations office (telephone<PHONE_NUMBER>) is the same as
the Mail address provided in the ADDRESSES section. Comments will be
available in the AD docket shortly after receipt.

Comments

    We provided the public the opportunity to participate in the
development of this AD. We have considered the comments received.

Request for Clarification

    Boeing and GE request clarification of the statement that the AD
action results from reports of engine flameout events during flight,
including reports of events where all engines simultaneously
experienced a flameout or other adverse operation. The commenters point
out that there have been no all-engine flameout events on MD-11 series
airplanes.
    We disagree. While we agree that no all-engine flameout events on
the MD-11 have occurred, single and multiple engine flameout events
have taken place. We did not change the AD.

Conclusion

    We have carefully reviewed the available data, including the
comments received, and determined that air safety and the public
interest require adopting the AD as proposed.

Costs of Compliance

    We estimate that this AD will affect 175 CF6-80C2D1F turbofan
engines installed on McDonnell Douglas Corporation MD-11 series
airplanes of U.S. registry. We estimate it will take about 6 work-hours
per ECU. The average labor rate is $80 per work-hour. Based on these
figures, we estimate the cost to U.S. operators to be $63,120. Our cost
estimate is exclusive of warranty coverage.

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.
    We are 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

    We have determined that this AD will not have federalism
implications under Executive Order 13132. This AD will 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 that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866;

    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979); 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.
    We prepared a summary of the costs to comply with this AD and
placed it in the AD Docket. You may get a copy of this summary at the
address listed under ADDRESSES.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Safety.

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the Federal Aviation Administration amends 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:

2007-22-07 General Electric Company: Amendment 39-15243. Docket No.
FAA-2007-28319; Directorate Identifier 2007-NE-27-AD.

Effective Date

    (a) This airworthiness directive (AD) becomes effective November
28, 2007.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to General Electric Company (GE) CF6-80C2D1F
turbofan engines, installed on, but not limited to, McDonnell
Douglas Corporation MD-11 series airplanes.

Unsafe Condition

    (d) This AD results from reports of engine flameout events
during flight, including reports of events where all engines
simultaneously experienced a flameout or other adverse operation. We
are issuing this AD to minimize engine flameout due to ice accretion
and shedding during flight. Exposure to ice crystals during flight
is believed to be associated with these flameout events.

Compliance

    (e) You are responsible for having the actions required by this
AD performed within the compliance times specified unless the
actions have already been done.

Interim Action

    (f) These actions are interim actions due to the on-going
investigation, and we may take further rulemaking actions in the
future based on the results of the investigation and field
experience.

Engine Electronic Control Unit (ECU) Software Removal

    (g) At the next shop visit of the engine or of the ECU,
whichever occurs first, and not to exceed 60 months from the
effective date of this AD, remove the following software versions
from the ECUs:

               Table 1.--Removal of ECU Software Versions
------------------------------------------------------------------------
         Software version                 Installed in ECU Part No.
------------------------------------------------------------------------
(1) 8.5.A.........................  1851M51P01, 1851M51P02, 1851M52P01,
                                     1851M52P02, 1851M53P01, 1851M53P02
(2) 8.3C..........................  1471M69P01, 1471M69P02, 1519M91P01
(3) 8.3.D.........................  1519M91P02
(4) 8.3.E.........................  1519M91P03, 1519M91P04
(5) 8.3.F.........................  1519M91P05
(6) 8.3.G.........................  1519M91P06, 1820M34P01
(7) 8.3.H.........................  1519M91P07, 1820M34P02
(8) 8.3.J.........................  1519M91P09, 1519M91P10, 1820M34P04,
                                     1820M34P05
------------------------------------------------------------------------

Previous Software Versions of ECU Software

    (h) For a period of 24 months after the effective date of this
AD, once an ECU containing a software version not listed in Table 1
of this AD is installed on an engine, that ECU can be replaced with
an ECU containing a previous version of software listed in Table 1.
    (i) Once the software version listed in Table 1 of this AD has
been removed and new FAA-approved software version is installed in
an ECU, reverting to those older software versions in that ECU is
prohibited.
    (j) After 60 months from the effective date of this AD, use of
an ECU with a software version listed in Table 1 of this AD is
prohibited.

Definitions

    (k) For the purposes of this AD:
    (1) Next shop visit of the ECU is when the ECU is removed from
the engine for overhaul or maintenance after the effective date of
this AD.
    (2) Next shop visit of the engine is when the engine is removed
from the airplane for maintenance in which a major flange is
disassembled after the effective date of this AD. The following
engine maintenance actions, either separately or in combination with
each other, are not considered a next shop visit of the engine:
    (i) Removal of the upper high pressure compressor (HPC) stator
case solely for airfoil maintenance.
    (ii) Module-level inspection of the HPC rotor stages 3-9 spool.
    (iii) Replacement of stage 5 HPC variable stator vane bushings
or lever arms.
    (iv) Removal of the accessory gearbox.
    (v) Replacement of the inlet gearbox polytetrafluoroethylene
seal.

Alternative Methods of Compliance

    (l) The Manager, Engine Certification Office, has the authority
to approve alternative methods of compliance for this AD if
requested using the procedures found in 14 CFR 39.19.

Special Flight Permits

    (m) Special flight permits are not authorized.

Related Information

    (n) Information on removing ECU software and installing new
software, which provides increased margin to flameout, can be found
in GE Service Bulletin No. CF6-80C2 S/B 73-0351, dated April 11,
2007.
    (o) Contact John Golinski, Aerospace Engineer, Engine
Certification Office, FAA, Engine and Propeller Directorate, 12 New
England Executive Park, Burlington, MA 01803; e-mail:
<EMAIL_ADDRESS>telephone:<PHONE_NUMBER>, fax: (781) 238-

7199, for more information about this AD.

    Issued in Burlington, Massachusetts, on October 17, 2007.
Peter A. White,
Acting Manager, Engine and Propeller Directorate, Aircraft
Certification Service.
[FR Doc. E7-20813 Filed 10-23-07; 8:45 am]

BILLING CODE 4910-13-P


MEMO To: Record RE: Document Not Available In EDOCKET The document associated with this DCN is not available in EDOCKET. Items that contain copyrighted or confidential materials are not available online. Some items may only be available in hard copy or on CD ROM at the Water Docket..