[Federal Register Volume 83, Number 34 (Tuesday, February 20, 2018)]
[Proposed Rules]
[Pages 7123-7124]
[FR Doc No: 2018-03341]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter I

[Docket No. FDA-2018-N-0128]

Nicotine Steering Committee; Establishment of a Public Docket;
Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; establishment of a public docket; request for
comments.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is
establishing a public docket to receive suggestions, recommendations,
and comments on topics or policy issues for consideration by FDA's
Nicotine Steering Committee (NSC). FDA would like to receive feedback
from interested parties, including academic institutions, regulated
industries, patient representatives, and other interested
organizations. These comments will help the Agency identify and address
priorities related to the use of therapeutic nicotine for combustible
tobacco product cessation.

DATES: Submit either electronic or written comments by April 16, 2018.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): 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-2018-N-0128 for ``Recommendations and Comments for the Food and
Drug Administration Nicotine Steering Committee.'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the 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.'' FDA will review
this copy, including the claimed confidential information, in its
consideration of comments. The second copy, which will have the claimed
confidential information redacted/blacked out, will be available for
public viewing and posted on https://www.regulations.gov. Submit both
copies to the 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: Allison Hoffman, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 1314, Silver
Spring, MD 20993,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The NSC was established in November 2017 to help develop and
implement nicotine policy and regulation. The primary focus of the NSC
is on the use of therapeutic nicotine for combustible tobacco product
cessation. The NSC is comprised of senior leaders from the Center for
Drug Evaluation and Research, the Center for Tobacco Products, and the
Office of the Commissioner. The NSC will ensure alignment of FDA's
Centers and facilitate consensus and development of unified FDA
positions on cross-cutting issues related to nicotine policy and
regulation. Additional staff from the Centers and other FDA offices
provide expertise as needed for specific policy topics under
consideration. While there are various other mechanisms available to
raise issues for Agency consideration, by establishing this public
docket FDA seeks to provide a mechanism for the public to recommend
specific topics for direct, collective engagement and consideration by
the NSC. The Agency believes that this process will also further
enhance transparency in FDA's approach to policy development and
implementation.

II. Establishment of a Public Docket and Request for Comments

    The docket is being established to solicit suggestions,
recommendations, and comments relating to the use of therapeutic
nicotine for combustible tobacco product cessation that may warrant
consideration by the NSC (see Staff Manual Guide 2010.20, FDA Nicotine
Steering Committee \1\). Topic suggestion submissions should describe
the following: (1) The nicotine policy issue recommended for discussion
(e.g., clarifying previous advice or precedents on a specified
therapeutic nicotine product policy topic, reconciling seemingly
differing perspectives within

FDA or between FDA and regulated industry on a specified therapeutic
nicotine product policy topic); (2) the rationale for doing so,
including why direct engagement by the NSC would be appropriate/
helpful; (3) recommendations on how the nicotine policy issue could be
addressed; and (4) existing policy documents (e.g., final guidance)
relevant to the nicotine product policy issue. Note that policy issues
concerning any draft guidance or proposed rule should be submitted to
the docket for that draft guidance or rulemaking.
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    \1\ https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/StaffManualGuides/UCM594385.pdf.
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    The Agency will carefully consider all comments submitted. FDA
generally will not respond directly to the person or organization
submitting the comment. In general, policy decisions reached by the NSC
are communicated and implemented in accordance with FDA's good guidance
practices regulation (21 CFR 10.115) or notice and comment procedures.

    Dated: February 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03341 Filed 2-16-18; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 150 (Monday, August 5, 2013)]
[Notices]
[Pages 47321-47322]
[FR Doc No: 2013-18731]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-P-0241]

Determination That CYTOXAN (Cyclophosphamide) for Injection Was
Not Withdrawn From Sale for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined that
CYTOXAN (cyclophosphamide) for Injection (lyophilized formulations),
100 milligrams (mg)/vial, 200 mg/vial, 500 mg/vial, 1 gram (g)/vial,
and 2 g/vial, and CYTOXAN (cyclophosphamide) for Injection (non-
lyophilized formulations), 100 mg/vial and 200 mg/vial, were not
withdrawn from sale for reasons of safety or effectiveness. This
determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for these products, if all other legal and
regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Christine Kirk, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6280, Silver Spring, MD 20993-0002, 301-
796-2465.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
    CYTOXAN (cyclophosphamide) for Injection (lyophilized
formulations), 100 mg/vial, 200 mg/vial, 500 mg/vial, 1 g/vial, and 2
g/vial, and CYTOXAN (cyclophosphamide) for Injection, 100 mg/vial and
200 mg/vial, are the subject of NDA 012142, held by Baxter Healthcare,
and initially approved on November 16, 1959. CYTOXAN for Injection is
an alkylating drug product indicated for treatment of malignant
lymphomas, Hodgkin's disease, lymphocytic lymphoma, mixed-cell type
lymphoma, histiocytic lymphoma, Burkitt's lymphoma, multiple myeloma,
leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary,
retinoblastoma, breast carcinoma, and minimal change nephrotic syndrome
in pediatric patients.
    CYTOXAN (cyclophosphamide) for Injection (lyophilized
formulations), 100 mg/vial, 200 mg/vial, 500 mg/vial, 1 g/vial, and 2
g/vial, and CYTOXAN (cyclophosphamide) for Injection, 100 mg/vial and
200 mg/vial, are currently listed in the ``Discontinued Drug Product
List'' section of the Orange Book.
    Foley & Lardner LLP submitted a citizen petition dated February 26,
2013 (Docket No. FDA-2013-P-0241), under 21 CFR 10.30, requesting that
the Agency determine whether CYTOXAN (cyclophosphamide) for Injection
(lyophilized formulations), 100 mg/vial, 200 mg/vial, 500 mg/vial, 1 g/
vial, and 2 g/vial, were voluntarily withdrawn or withheld from sale
for reasons of safety or effectiveness. Although the citizen petition
did not address the non-lyophilized 100 mg/vial and 200 mg/vial
formulations, those strengths have also been discontinued. On our own
initiative, we have also determined whether those strengths were
withdrawn for safety or effectiveness reasons.
    After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec.  314.161 that CYTOXAN (cyclophosphamide) for Injection
(lyophilized formulations), 100mg/vial, 200mg/vial, 500 mg/vial, 1 g/
vial, and 2 g/vial, and CYTOXAN (cyclophosphamide) for Injection, 100
mg/vial and 200 mg/vial, were not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other
information suggesting that CYTOXAN (cyclophosphamide) for Injection
(lyophilized formulations), 100 mg/vial, 200 mg/vial, 500 mg/vial, 1 g/
vial, and 2 g/vial, or CYTOXAN (cyclophosphamide) for Injection, 100
mg/vial and 200 mg/vial, were withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of CYTOXAN (cyclophosphamide) for Injection
(lyophilized formulations), 100 mg/vial, 200 mg/vial, 500 mg/vial, 1 g/
vial, and 2 g/vial, and CYTOXAN (cyclophosphamide) for Injection, 100
mg/vial and 200 mg/vial, from sale. We have also independently
evaluated relevant literature and data for possible postmarketing
adverse events. We have found no information that would indicate that
these products were withdrawn from sale for reasons of safety or
effectiveness.
    Accordingly, the Agency will continue to list CYTOXAN
(cyclophosphamide) for Injection (lyophilized formulations), 100 mg/
vial, 200 mg/vial, 500 mg/vial, 1 g/vial, and 2 g/vial, and CYTOXAN
(cyclophosphamide) for Injection, 100 mg/vial and 200 mg/vial, in the
``Discontinued Drug Product List'' section of the Orange Book. The
``Discontinued Drug Product List'' delineates, among other items, drug
products that have been discontinued from marketing for reasons other
than safety or effectiveness. ANDAs that refer to CYTOXAN
(cyclophosphamide) for Injection (lyophilized formulations), 100 mg/
vial, 200 mg/vial, 500 mg/vial, 1 g/vial, and 2 g/vial, or CYTOXAN
(cyclophosphamide) for Injection, 100 mg/vial and 200 mg/vial, may be
approved by the Agency as long as they meet all other legal and
regulatory requirements for the approval of ANDAs. If FDA determines
that labeling for these drug products should be revised to meet current
standards, the Agency will advise ANDA applicants to submit such
labeling.

    Dated: July 30, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-18731 Filed 8-2-13; 8:45 am]
BILLING CODE 4160-01-P


EPA BIOPESTICIDES AND POLLUTION PREVENTION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Biopesticides and Pollution Prevention Division contact: [insert name and telephone number with area code]

INSTRUCTIONS:  Please utilize this outline in preparing the pesticide petition.  In cases where the outline element does not apply, please insert "NA-Remove" and maintain the outline. Please do not change the margins, font, or format in your pesticide petition. Simply replace the instructions that appear in green, i.e., "[insert company name]," with the information specific to your action.

SUBMISSION: E-mail the completed template to<EMAIL_ADDRESS> TEMPLATE:

DSM Food Specialties, B.V.

[Insert petition number]

	EPA has received a pesticide petition ([insert petition number]) from DSM Food Specialties, B.V., PO Box 1, 2600 MA Delft, The Netherlands proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.

(Options (pick one)        	1. by establishing a tolerance for residues of NA-Remove

	2. to establish an exemption from the requirement of a tolerance for NA-Remove 	 	3. to establish an amendment/expansion of an existing tolerance exemption for the

(Options (pick one)      microbial pesticide  NA-Remove            biochemical pesticide Natamycin

 plant-pesticide NA-Remove in or on NA-Remove           	 Pursuant to section 408(d)(2)(A)(i) of  FFDCA, as amended, DSM Food Specialties, B.V. has submitted the following summary of information, data, and arguments in support of their pesticide petition. This summary was prepared by DSM Food Specialties, B.V. and EPA has not fully evaluated the merits of the pesticide petition. The summary may have been edited by EPA if the terminology used was unclear, the summary contained extraneous material, or the summary unintentionally made the reader conclude that the findings reflected EPA's position and not the position of the petitioner.

I. DSM Food Specialties, B.V. Petition Summary        	[Insert petition number]

A. Product Name and Proposed Use Practices

      Natamycin  is already approved for use as a fungistat to prevent and control mold and yeast spores in the growth media of mushrooms produced in enclosed mushroom facilities (EPA Reg. No. 87485-2) and for use on pineapple as a post-harvest treatment (EPA Reg. No. 87485-3). Additional uses are being proposed to control several postharvest diseases in or on citrus, pome, stone fruit crop groups, avocado, kiwi, mango and pomegranates by dip, drench, flood or spray in packinghouse facilities.

B. Product Identity/Chemistry

      1. Identity of the pesticide and corresponding residues. Natamycin L contains 10.34% (by wt) Natamycin anhydrous.

	2. Magnitude of residues at the time of harvest and method used to determine the residue. Not applicable.

      3. A statement of why an analytical method of detecting and measuring the levels of the pesticide residue are not needed. An analytical method for detecting and measuring the levels of pesticide residue for Natamycin is not applicable. It is expected that, when used as proposed Natamycin would not result in residues that are of toxicological concern.

C. Mammalian Toxicological Profile

	The toxicology data indicate that the active ingredient, Natamycin is of low acute toxicity and is not a developmental toxicant, a mutagen, or toxic via repeat oral exposure.

Acute Toxicity: Acute toxicity studies on Natamycin TGAI (98.17% and 98.27% pure), confirm a low toxicity profile. The acute toxicity data show nontoxicity for all routes of exposure. It can be concluded that any dietary risks associated with Natamycin would be negligible.

1. The acute oral LD50 in rats was greater than 2,000 milligrams per kilogram (mg/kg) bodyweight. There were no observed toxicological effects on the test subjects in the acute oral study submitted (MRID No. 48105505). Natamycin is classified as Toxicity Category III for acute oral toxicity.

2.   The acute dermal LD50 in rats was greater than 5,050 mg/kg body weight (MRID 48105506). Natamycin is classified as Toxicity Category IV for acute dermal toxicity.

3.   The acute inhalation LC50 was greater than 2.39 milligrams per liter (mg/L) in rats and showed no significant inhalation toxicity (MRID 48105507). Natamycin is classified as Toxicity Category IV for acute inhalation toxicity.

4.   A primary eye irritation study on rabbits indicated that Natamycin is severely irritating to the eye but with no effects observed at 24 hours after treatment (MRID 48015508). Natamycin is classified as Toxicity Category IV for primary eye irritation.

5. A skin irritation study on rabbits indicates that Natamycin is slightly irritating (MRID 48105509). Natamycin is classified as Toxicity Category IV for primary skin irritation.

6.   Data indicate that Natamycin is not a dermal sensitizer (MRID 48105510).

Mutagenicity: Two mutagenicity studies, using Natamycin TGAI were performed. These studies confirm that there are no expected dietary or non-occupational risks of mutagenicity with regard to food use of Natamycin.

1. A Bacterial Reverse Gene Mutation Test (MRID No. 48105513) investigating doses of test substance up to those that were cytotoxic, both with and without metabolic S9 activation, found no incidences of a 2-fold or greater increase in the number of revertants compared to the corresponding solvent control in two independently repeated experiments. Natamycin is considered to be non-mutagenic under the conditions of this assay.

2. An in vitro Mammalian Cell Chromosome Aberration Test (MRID No. 48105514) tested Natamycin genotoxicity on cultured peripheral human lymphocytes in the presence and absence of metabolic S9 activation. Natamycin did not induce a statistically significant or biologically relevant increase in the number of cells with chromosome aberrations in the absence and in the presence of S9-mix, in two independently repeated experiments. In addition, all of the negative, solvent, and positive controls gave appropriate responses. Natamycin is considered to be non-mutagenic and does not cause chromosome aberrations.

Subchronic Toxicity: In a subchronic oral toxicity study using Natamycin TGAI, doses of 125 and 500 mg/kg/day showed no treatment related findings. The highest concentration l level, 2,000 mg/kg/day, showed reduced weight for both male and female rats (MRID 48105511). The Agency did not consider the temporary decrease in body weight or food intake observed in the 2,000 mg/kg bw/day test group to be an adverse effect, as this is likely due to the palatability of the food containing this high dose of test substance. The Agency established the NOAEL (No Observed Adverse Effect Level) for this study as 2,000 mg/kg bw/day. A LOAEL (Lowest Observed Adverse Effect Level) was not identified, suggesting that the test animals could have tolerated a higher dose.

Developmental Toxicity: A developmental toxicity study using Natamycin TGAI (MRID 48105512) showed no discernable effects on growth, reproduction, teratological or mutagenic responses, or on gross and microscopic pathology, at concentration levels 0, 5, 15 and 50 mg/kg bw/day.

D. Aggregate Exposure

      1. Dietary exposure. Dietary exposure from the additional uses of Natamycin L being proposed for the control of postharvest fungal diseases on citrus, pome, stone fruit crop groups, avocado, kiwi, mango and pomegranates by dip, drench or spray in packinghouse facilities is expected to be minimal.

            i. Food. Natamycin has a long history of use. Natamycin has been used as a food preservative worldwide for over 50 years and is approved as a food additive/preservative by the European Union, the World Health Organization and individual countries for use as a fungistat to suppress mold on cheese, meats and sausage. In the United States, Natamycin is approved by The Food and Drug Administration (FDA) as a direct food additive/preservative for the inhibition of mold and yeast on the surface of cheeses (21 CFR § 172.155) and as an additive to the feed and drinking water of broiler chickens to retard the growth of specific molds (21 CFR § 573.685). Natamycin is also FDA approved for use as a treatment to suppress fungal eye infections such as blepharitis, conjunctivitis, and keratitis. Natamycin is already approved for use as a fungistat to prevent and control mold and yeast spores in the growth media of mushrooms produced in enclosed mushroom facilities (EPA Reg. No. 87485-2) and to control fungal growth postharvest on pineapples indoors (EPA Reg. No. 87485-3).                          The results of toxicity testing indicate there is little if any risk to human health from exposure to Natamycin. The absence of toxicity in laboratory animals demonstrates the lack of toxicological concern for any increase in dietary exposure from the use Natamycin L. In a review of toxicological literature by the European Food Safety Agency (EFSA, 2009), Natamycin was shown to be poorly absorbed by gastrointestinal systems of mammals and rapidly excreted in the feces (Blankwater and Hespe, 1979; Hespe and Meier, 1980; both reviewed and cited in EFSA, 2009). In addition, Natamycin is rapidly degraded by stomach acids, with a 1-hour half-life in simulated gastric juice (Morgenstern and Muskens, 1976; reviewed and cited in EFSA, 2009). In addition, Daamen and van den Berg (1985) and Kiermeier and Zierer (1975) demonstrated that Natamycin remained on the surface of cheese and only slight amounts penetrated into the cheese. It is expected the same thing would occur, when fruit is treated with Natamycin postharvest, that Natamycin will remain on the surface of the fruit and very little would penetrate into the fruit and add to the dietary intake.                           All inert ingredients used in the end-use product, Natamycin L, are approved for food use under 40 CFR 180.950 and 40 CFR 180.960; and are considered to be Generally Recognized As Safe (GRAS) by FDA.

            ii. Drinking water. There are no concerns for exposure of humans to Natamycin in drinking water. Based on the additional proposed postharvest uses in treatment facilities on citrus fruit, pome fruit, stone fruit and cherries it is highly unlikely that residues of Natamycin will enter any sources of drinking water. In addition, due to its low solubility in water its concentration in surface waters would never exceed 50 ppm. Natamycin is also extremely sensitive to UV light and is completely degraded by UV within 24 hours of exposure in aqueous solution (Koontz et. al., 2003).

      2. Non-dietary exposure. The potential for non-dietary exposure to the general population, including infants and children is not expected because Natamycin is not approved for residential uses and the use sites are for enclosed mushroom production facilities or postharvest treatment facilities.

E. Cumulative Effects

      The Food Quality Protection Act of 1996 requires the EPA to consider the cumulative effects of chemicals with a common mechanism of toxicity in its tolerance assessment decisions. There is no indication that Natamycin has a common mechanism of action with other compounds to result in any cumulative effects.

F. Safety Determination

      1. U.S. population. Toxicity studies have shown that Natamycin is non-toxic to mammals following acute exposures. These results indicate the product is not of toxicological concern for the general population when used as proposed on the label. Based on the data available, there is a reasonable certainty of no harm to the general US population from exposure to Natamycin from the proposed additional uses.

      2. Infants and children. As mentioned above, it is expected that, when used as proposed, Natamycin would not result in residues that are of concern for potential toxicity. Based on the data provided, there is a reasonable certainty of no harm for infants and children from exposure to Natamycin from the proposed additional uses.

G. Effects on the Immune and Endocrine Systems

      To date there is no evidence to suggest that Natamycin functions in a manner similar to any known hormone, or that it acts as an endocrine disrupter.

H. Existing Tolerances

Natamycin is exempt from the requirement of a tolerance as stated at 40 CFR § 180.1315:

40 CFR § 180.1315 Natamycin; exemption from the requirement of a tolerance.

An exemption from the requirement of a tolerance is established for residues of natamycin in or on mushrooms when applied as a fungistat to prevent the germination of fungal spores on mushrooms produced in enclosed mushroom production facilities, and in or on pineapples when applied as a fungistat in accordance with label directions and good agricultural practices.

I. International Tolerances

	There are no current tolerances or tolerance exemptions in place for Natamycin.

4850-5378-7176, v.  1


[Federal Register Volume 78, Number 17 (Friday, January 25, 2013)]
[Notices]
[Pages 5474-5475]
[FR Doc No: 2013-01563]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[USCG-2013-0029]

Great Lakes Pilotage Advisory Committee

AGENCY: Coast Guard, DHS.

ACTION: Committee Management; Notice of Federal Advisory Committee
Meeting.

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SUMMARY: The Great Lakes Pilotage Advisory Committee (GLPAC) will meet
on February 11, 2013, in Cleveland, Ohio. The meeting will be open to
the public.

DATES: GLPAC will meet on Monday, February 11, 2013, from 12:30 p.m. to
3:30 p.m. Please note the meeting may close early if the committee
completes its business. Written material and requests to make oral
presentations should reach us on or before February 8, 2012.

ADDRESSES: The meeting will be held at Coast Guard District 9
Headquarters, 1240 East 9th Street, Cleveland, Ohio 44199, in
conference room 1629. All visitors to Coast Guard District 9
Headquarters will have to pre-register to be admitted to the building.
Please provide your name, telephone number and organization by close of
business on February 8, 2013, to the contact person listed in FOR
FURTHER INFORMATION CONTACT below. Additionally, all visitors to Coast
Guard District 9 Headquarters must produce valid photo identification
for access to the facility.
    For information on facilities or services for individuals with
disabilities or to request special assistance at the meeting, contact
the person listed in FOR FURTHER INFORMATION CONTACT below as soon as
possible.
    To facilitate public participation, we are inviting public comment
on the issues to be considered by the committee as listed in the
``Agenda'' section below. Comments must be submitted in writing no
later than February 8, 2013, and must be identified by [USCG-2013-0029]
and may be submitted by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Management Facility (M-30), U.S. Department
of Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington DC 20590-0001.
     Hand Delivery: Same as mail address above between 9 a.m.
and 5 p.m., Monday through Friday, except Federal holidays. The
telephone number is<PHONE_NUMBER>. To avoid duplication, please use only
one of these four methods.
    Instructions: All submissions received must include the words
``Department of Homeland Security'' and the docket number for this
action. Comments received will be posted without alteration at http://www.regulations.gov, including any personal information provided. You
may review a Privacy Act notice regarding our public dockets in the
January 17, 2008, issue of the Federal Register (73 FR 3316).
    Docket: For access to the docket to read documents or comments
related to this notice, go to http://www.regulations.gov, and use
``USCG-2013-0029'' as your search term.
    A public comment period of up to one hour will be held during the
meeting on February 11, 2013, after the committee completes its work on
the agenda given under SUPPLEMENTARY INFORMATION. Speakers are
requested to limit their comments to 5 minutes. Please note that the
public comment period may end before the hour allotted, following the
last call for comments. Contact the individual listed below to register
as a speaker.

FOR FURTHER INFORMATION CONTACT: Mr. David Dean, GLPAC Alternate
Designated Federal Officer (ADFO), Commandant (CG-5522), U.S. Coast
Guard Headquarters, 2100 Second Street SW., Stop 7580, Washington, DC
20593-7580; telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>, or email at
<EMAIL_ADDRESS>If you have questions on viewing or submitting
material to the docket, call Renee V. Wright, Program Manager, Docket
Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice of this meeting is given under the
Federal Advisory Committee Act, 5 U.S.C. App. (Pub. L. 92-463). GLPAC
was established under the authority of 46 U.S.C. 9307, and makes
recommendations to the Secretary of Homeland Security and the Coast
Guard on matters relating to Great Lakes pilotage, including review of
proposed Great Lakes pilotage regulations and policies.
    GLPAC expects to meet at least once more this year at the
conclusion of the comprehensive pilotage study mentioned in the agenda
below. Further information about GLPAC is available by searching on
``Great Lakes Pilotage Advisory Committee'' at http://www.faca.gov.
Agenda

    The GLPAC will meet to review, discuss and formulate
recommendations on the following issues:
    2013/2014 Appendix A rulemakings which establishes the rates that
pilots can charge industry for their services.
    Memorandum of Arrangements between the U.S. and Canada concerning
definitions and procedures for pilotage in the shared waters of the
Great Lakes.
    Establishing a permanent split of St. Lawrence River pilotage
assignments through a change point at Iroquois Lock.
    Status of vacant ratemaking position in Great Lakes Pilotage
Division.
    Status of Great Lakes Pilotage Division office location.
    Presentation and discussion of the latest draft of the
comprehensive pilotage study; a copy of the draft study is posted to
the electronic docket. Please see instructions below for access.
    This will be followed by a public comment period of up to one hour.
Speakers are requested to limit their comments to 5 minutes.
    More detailed information and materials relating to these issues
appear in the docket, including a copy of the draft pilotage study, at
http://www.regulations.gov. Use ``USCG-2013-0029'' as your search term.

    Dated: January 18, 2013.
D.A. Goward,
Director Marine Transportation Systems, U.S. Coast Guard.
[FR Doc. 2013-01563 Filed 1-24-13; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: December 13, 2007 (Volume 72, Number 239)]
[Notices]
[Page 70911-70912]
[DOCID:fr13de07-107]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-56925; File No. SR-CBOE-2007-141]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Immediate Effectiveness of Proposed
Rule Change To Amend CBOE Rule 2.1 Relating to the Appointment of the
Chairman and Members of CBOE's Business Conduct Committee

 December 7, 2007.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on November 27, 2007, the Chicago Board Options Exchange, Incorporated
(``CBOE'' or ``Exchange'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I and II below, which Items have been substantially prepared by
the CBOE. The Exchange filed the proposal pursuant to Section
19(b)(3)(A)(iii) of the Act \3\ and Rule 19b-4(f)(3) thereunder,\4\
which renders the proposal effective upon filing with the Commission.
The Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \4\ 17 CFR 240.19b-4(f)(3).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The CBOE proposes to amend Exchange Rule 2.1 pertaining to the
appointment of the chairman and members of CBOE's Business Conduct
Committee (``BCC''). The text of the proposed rule change is available
at the Exchange, on the Exchange's Web site at http://www.cboe.com, and

at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of, and basis for, the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
Sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of the proposed rule change is to amend CBOE Rule 2.1
by modifying the BCC appointment process. Currently, the Exchange's
Vice Chairman of the Board (``member Vice Chairman''), a member
position, has the authority to: (i) Appoint the chairman and members of
the BCC, with the approval of the Board; (ii) remove members in the
BCC, with or without cause; and (iii) fill a vacancy in the BCC for the
remainder of the term (collectively referred to as the ``Appointment
Process'').\5\ CBOE proposes to transfer the Appointment Process
authority from the member Vice Chairman to the President \6\ of the
Exchange.\7\ CBOE believes that the modification to this rule will
enhance CBOE's disciplinary process because the BCC Appointment Process
will now be the responsibility of a non-member

executive officer, who is not subject to the Exchange's disciplinary
jurisdiction.
---------------------------------------------------------------------------

    \5\ See CBOE Rule 2.1(a).
    \6\ CBOE's President is the chief operating officer of CBOE,
and, among other duties, oversees the Member and Regulatory Services
Division of CBOE.
    \7\ CBOE believes that this rule amendment is similar to the
International Securities Exchange (``ISE'') Rule 200, which grants
its CEO the authority to appoint members of committees, including
ISE's Business Conduct Committee with Board approval. See ISE Rule
200.
---------------------------------------------------------------------------

2. Statutory Basis
    In modifying the BCC Appointment Process to place the
responsibility with a non-member executive officer who is not subject
to the Exchange's disciplinary jurisdiction, the Exchange believes that
the proposed rule change is consistent with Section 6(b) of the Act \8\
in general, and with Section 6(b)(5) of the Act \9\ in particular,
which requires, among other things, that the rules of the Exchange be
designed to prevent fraudulent and manipulative acts and practices, to
promote just and equitable principles of trade, to foster cooperation
among persons engaged in facilitating securities transactions, and, in
general, to protect investors and the public interest.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    The Exchange has neither solicited nor received written comments on
the proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The Exchange has designated this proposal as concerned solely with
the administration of the Exchange under Section 19(b)(3)(A)(iii) of
the Act,\10\ and Rule 19b-4(f)(3) thereunder,\11\ which renders the
proposal effective upon filing with the Commission.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \11\ 17 CFR 240.19b-4(f)(3).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors or otherwise in
furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-CBOE-2007-141 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-CBOE-2007-141. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of CBOE. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-CBOE-2007-141 and should be
submitted on or before January 3, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\12\
---------------------------------------------------------------------------

    \12\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. E7-24120 Filed 12-12-07; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 43 (Monday, March 5, 2012)]
[Notices]
[Pages 13164-13165]
[FR Doc No: 2012-5207]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-66485; File No. SR-FICC-2012-01]

Self-Regulatory Organizations; Fixed Income Clearing Corporation;
Notice of Filing of Proposed Rule Change To Make a Technical Correction
to the Rule Relating to the Calculation of Funds-Only Settlement
Amounts for Repo Brokers

February 28, 2012.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 \2\ thereunder notice is hereby given that
on February 14, 2012, the Fixed Income Clearing Corporation (``FICC'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I and II below, which Items
have been prepared primarily by FICC. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The proposed rule change consists of modifications to Rule 19,
Section 4 of the rules of the Government Securities Division (``GSD'')
of FICC.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, FICC included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. FICC has prepared summaries, set forth in sections A, B,
and C below, of the most significant aspects of such statements.\3\
---------------------------------------------------------------------------

    \3\ The Commission has modified the text of the summaries
prepared by FICC.
---------------------------------------------------------------------------

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    The purpose of this filing is to make technical corrections to GSD
Rule 19 (Special Provisions For Brokered Repo Transactions), Section 4
(Calculations of Funds-Only Settlement Amounts for Repo Brokers) as
described below. GSD Rule 19, Section 4 states that FICC may retain any
amount of a Credit Forward Mark Adjustment Payment that is in excess of
the Cap \4\ and that interest earned on such amount shall be paid to
the Repo Broker on the subsequent business day. The second part of this
sentence is incorrectly stated because FICC pays interest to those who
were debited forward mark adjustment amounts not those who were
credited such amounts. On the following day (i.e., the day after the
broker received the Credit Forward Mark Adjustment Payment) when the
broker is debited the interest for the use of funds it received as a
credit, the broker will be debited the interest on the amount that it
actually received as a credit (i.e., it will not be debited interest
for the amount of Credit payment withheld above the Cap). The rule is
also revised to state that Repo Brokers with more than one Segregated
Repo Account must aggregate Debit Forward Mark Adjustments and Credit
Forward Mark Adjustment Payments in those accounts for purposes of the
Cap. The Repo Brokers currently comply with this correction and the
revision reflects current practice.
---------------------------------------------------------------------------

    \4\ The GSD rules define ``Cap'' as any Debit Forward Mark
Adjustment Payment or Credit Forward Mark Adjustment Payment up to a
dollar amount, as determined by FICC from time to time, that is
automatically collected from or paid to the Repo Broker, as
applicable.
---------------------------------------------------------------------------

    FICC believes that the proposed rule change is consistent with
Section 17A of the Act and the rules and regulations thereunder because
it makes technical corrections to its rules to ensure that they are
consistent and accurate.

B. Self-Regulatory Organization's Statement on Burden on Competition

    FICC does not believe that the proposed rule change will have any
impact or impose any burden on competition.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    Written comments relating to the proposed rule change have not yet
been solicited or received. FICC will notify the Commission of any
written comments received by FICC.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self- regulatory organization consents, the Commission will:
    (A) By order approve or disapprove the proposed rule change or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-FICC-2012-01 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-FICC-2012-01. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,

Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at FICC's principal office and on FICC's Web
site at http://dtcc.com/downloads/legal/rule_filings/2012/ficc/SR_FICC_2012_01.pdf. All comments received will be posted without
change; the Commission does not edit personal identifying information
from submissions. You should submit only information that you wish to
make available publicly.
    All submissions should refer to File Number SR-FICC-2012-01 and
should be submitted on or before March 26, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\5\
---------------------------------------------------------------------------

    \5\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-5207 Filed 3-2-12; 8:45 am]
BILLING CODE 8011-01-P


From:
Jones, DonnaLee<EMAIL_ADDRESS>Sent:
Tuesday, August 6, 2019 5:50 PM
To:
Eric Stuart<EMAIL_ADDRESS>D'Angelo, Wayne J<EMAIL_ADDRESS>Subject:
EAF NSPS deadline settlement dates

Hello Eric and Wayne  -  We have negotiated dates for the EAF NSPS review. See attached for the legal documents.

EAF NSPS proposal date is 11/1/21 and the final date is 11/1/22.

We have not started any work on the EAF NSPS at all. The II&S RTR is close to a proposal. In the meantime, we are working on getting the Coke industry to QA their ICR data from 2016 for the RTR for subpart CCCCC (pushing, quenching, battery stacks). I had started trying to do this task exactly one year ago in the last free time window but got dragged back into II&S too soon, so this has been the first opportunity continue the Coke work. Just a sampling of how busy we have been with "other" issues.

FYI - The court-ordered due date for II&S final RTR rule is March 13, 2020. We also have been sued for deadline on Coke Ovens RTR and are in the pre-negotiating/litigation stage.

Nothing more I can think to say on EAFs or other activity, but if you want to chat sometime, let me know.
_____________________________________________________________
Regards,
Donna Lee Jones, Ph.D.
Senior Technical Advisor, Metals Sector
U. S. Environmental Protection Agency
Office of Air Quality Planning and Standards
Sector Policies and Programs Division / Metals & Inorganic Chemicals Gr (D 243-02)
Research Triangle Park, NC  27711  Tele:<PHONE_NUMBER>  Fax<PHONE_NUMBER>
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
"Reasonableness never fails to be appreciated."  - anon.

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