[Federal Register: April 19, 2010 (Volume 75, Number 74)]
[Rules and Regulations]
[Page 20268-20269]
[DOCID:fr19ap10-5]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

[Docket No. FDA-2010-N-0002]

Implantation or Injectable Dosage Form New Animal Drugs; Change
of Sponsor; Propofol

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Final rule.

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

SUMMARY:  The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect a change of sponsor for a new animal drug
application (NADA) from Intervet, Inc., to Teva Animal Health, Inc.

DATES:  This rule is effective April 19, 2010.

FOR FURTHER INFORMATION CONTACT:  David R. Newkirk, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Intervet, Inc., 56 Livingston Ave.,
Roseland, NJ 07068, has informed FDA that it has transferred ownership
of, and all rights and interest in, approved NADA 141-070 for RAPINOVET
(propofol), an

injectable anesthetic, to Teva Animal Health, Inc., 3915 South 48th
Street Ter., St. Joseph, MO 64503. Accordingly, the agency is amending
the regulations in 21 CFR 522.2005 to reflect the transfer of ownership
and a current format.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 522

    Animal drugs.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 522 is
amended as follows:

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 522 continues to read as
follows:

    Authority: 21 U.S.C. 360b.

0
2. Revise Sec.  522.2005 to read as follows:

Sec.  522.2005   Propofol.

    (a) Specifications. Each milliliter of emulsion contains 10
milligrams (mg) propofol.
    (b) Sponsors. See sponsor numbers in Sec.  510.600(c) of this
chapter.
    (1) No. 059130 for use as in paragraph (c) of this section.
    (2) No. 000074 for use as in paragraphs (c)(1)(i), (c)(2), and
(c)(3) of this section.
    (c) Conditions of use in dogs and cats--(1) Amount. The drug is
administered by intravenous injection as follows:
    (i) Dogs. For induction of general anesthesia without the use of
preanesthetics the dosage is 5.5 to 7.0 mg per kilogram (mg/kg) (2.5 to
3.2 mg/pound (lb)); for the maintenance of general anesthesia without
the use of preanesthetics the dosage is 1.1 to 3.3 mg/kg (0.5 to 1.5
mg/lb). The use of preanesthetic medication reduces propofol dose
requirements.
    (ii) Cats. For induction of general anesthesia without the use of
preanesthetics the dosage is 8.0 to 13.2 mg/kg (3.6 to 6.0 mg/lb). For
the maintenance of general anesthesia without the use of preanesthetics
the dosage is 1.1 to 4.4 mg/kg (0.5 to 2.0 mg/lb). The use of
preanesthetic medication reduces propofol dose requirements.
    (2) Indications for use. As a single injection to provide general
anesthesia for short procedures; for induction and maintenance of
general anesthesia using incremental doses to effect; for induction of
general anesthesia where maintenance is provided by inhalant
anesthetics.
    (3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.

    Dated: April 13, 2010.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 2010-8945 Filed 4-16-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 77, Number 176 (Tuesday, September 11, 2012)]
[Notices]
[Pages 55814-55815]
[FR Doc No: 2012-22327]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 405-105]

Exelon Generation Company, LLC; Notice of Application for
Amendment of License and Soliciting Comments, Motions To Intervene and
Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Application Type: Temporary variance of minimum flow requirement
of license.
    b. Project No: 400-105.
    c. Date Filed: July 25, 2012.
    d. Applicant: Exelon Generation Company, LLC.
    e. Name of Project: Conowingo Hydroelectric Project.
    f. Location: The Conowingo Project is located on the Susquehanna
River in Harford and Cecil counties in Maryland, and York and Lancaster
counties in Pennsylvania.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Ms. Kathleen Barr[oacute]n, Senior Vice
President-Federal Regulatory Affairs and Wholesale Market Policy,
Exelon, 101 Constitution Avenue NW., Suite 400 East, Washington, DC
20001,<PHONE_NUMBER><EMAIL_ADDRESS>    i. FERC Contact: Ms. Kelly Houff at<PHONE_NUMBER>,
<EMAIL_ADDRESS>    j. Deadline for filing comments, motions to intervene, and
protests: September 20, 2012.
    All documents may be filed electronically via the Internet. See, 18
CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web
site at http://www.ferc.gov/docs-filing/efiling.asp. If unable to be
filed electronically, documents may be paper-filed. To paper-file, an
original and seven copies should be mailed to: Secretary, Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426. Commenters can submit brief comments up to 6,000 characters,
without prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and
contact information at the end of your comments.
    Please include the project number (P-405-105) on any comments,
motions, or recommendations filed.
    k. Description of Request: Exelon Generation Company, LLC requests
Commission approval for a variance of the minimum flow requirement of
the project license. Due to drought conditions and low river flows in
the Susquehanna River, Exelon requests that they be allowed immediately
to include plant leakage of about 530 cubic feet per second (cfs) in
the required minimum flow discharge until September 14, 2012, or until
flow conditions improve where the Conowingo Project no longer requires
leakage be included as part of the minimum flow requirement. According
to the license, for the period June 1 through September 14, annually,
Exelon must provide a minimum flow release (not including leakage)
below the dam of 5,000 cfs, or inflow (as measured at the USGS gage
0156000 at Marietta, PA), whichever is less. During the fall period,
September 15 through November 30, Exelon is required to release a
minimum flow of 3,500 cfs not including leakage, or inflow to the
project whichever is less, as measured at the Marietta gage.
    Exelon is concerned about the ability of the Conowingo Project to
maintain an adequate pond level and storage capacity during the current
low flow period. Maintaining storage is necessary for generation and to
ensure an adequate water supply for recreational and consumptive uses
of the Conowingo Reservoir to include operation of Peach Bottom Atomic
Power Station and Muddy Run Pumped Storage Project. Including plant
leakage in the minimum flow discharge will contribute to the
maintenance of these project water uses during this low flow period.
During the period of the minimum flow variance, Exelon will conduct
daily monitoring of the Susquehanna River below the dam for potential
environmental effects. If any abnormal or adverse conditions are
observed, Exelon will promptly notify the Maryland Department of
Natural Resources. In addition, Exelon agrees that during the period of
the variance, it will not operate more than two units, each rated at
54,000 horsepower, unless PJM Interconnection LLC directs Exelon to
operate in peaking mode: (1) As a result of a system emergency; or (2)
to manage Conowingo pond levels.
    l. Locations of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street NE., Room 2A, Washington,
DC 20426, or by calling<PHONE_NUMBER>. This filing may also be viewed on
the Commission's Web site at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. You may also register
online at http://www.ferc.gov/docs-filing/esubscription.asp to be
notified via email of new filings and issuances related to this or
other pending projects. For assistance, call<PHONE_NUMBER> or email
<EMAIL_ADDRESS>for TTY, call<PHONE_NUMBER>. A copy is also
available for inspection and reproduction at the address in item (h)
above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Filing and Service of Responsive Documents: Any filing must (1)
bear in all capital letters the title ``COMMENTS''; ``PROTESTS'', or
``MOTION TO INTERVENE'' as applicable; (2) set forth in the heading the
name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person protesting or intervening; and (4) otherwise
comply with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis and otherwise comply with the requirements of 18 CFR
4.34(b). Agencies may obtain copies of the application directly from
the applicant. A copy of any protest or motion to intervene must be
served upon each representative of the applicant specified

in the particular application. If an intervener files comments or
documents with the Commission relating to the merits of an issue that
may affect the responsibilities of a particular resource agency, they
must also serve a copy of the document on that resource agency. A copy
of all other filings in reference to this application must be
accompanied by proof of service on all persons listed in the service
list prepared by the Commission in this proceeding, in accordance with
18 CFR 4.34(b) and 385.2010.

    Dated: September 5, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-22327 Filed 9-10-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 32 (Wednesday, February 16, 2011)]
[Notices]
[Pages 9022-9023]
[FR Doc No: 2011-3475]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0248]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Format and Content Requirements for
Over-the-Counter Drug Product Labeling

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
collection of information entitled ``Format and Content Requirements
for Over-the-Counter Drug Product Labeling'' has been approved by the
Office of Management and Budget (OMB) under the Paperwork Reduction Act
of 1995.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Federal Register of August 13, 2010
(75 FR 49495), the Agency announced that the proposed information
collection had been submitted to OMB for review and clearance under 44
U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number. OMB has now approved the
information collection and has assigned OMB control number 0910-0340.
The approval expires on January 31, 2014. A copy of the supporting
statement for this information collection is available on

the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: February 11, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
FR Doc. 2011-3475 Filed 2-15-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 79, Number 13 (Tuesday, January 21, 2014)]
[Notices]
[Pages 3388-3389]
[FR Doc No: 2014-00939]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0001]

Microbiology Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Microbiology Devices Panel of the Medical
Devices Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on March 12, 2014, from 8
a.m. to 6 p.m.
    Location: College Park Holiday Inn, Ballroom, 10000 Baltimore Ave.,
College Park, MD 20740;<PHONE_NUMBER>.
    Contact Person: Shanika Craig, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver
Spring, MD 20993<EMAIL_ADDRESS>301-796-6639, or FDA
Advisory Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in
the Washington, DC area). A notice in the Federal Register about last
minute modifications that impact a previously announced advisory
committee meeting cannot always be published quickly enough to provide
timely notice. Therefore, you should always check the Agency's Web site
at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to
the appropriate advisory committee meeting link, or call the advisory
committee information line to learn about possible modifications before
coming to the meeting.
    Agenda: On March 12, 2014, the committee will discuss, make
recommendations, and vote on a premarket approval application for a new
indication for the cobas Human Papillomavirus (HPV) Test, sponsored by
Roche Molecular Systems, Inc. The cobas HPV Test is a qualitative in
vitro test for the detection of HPV that is currently approved for use
in conjunction with cervical cytology. Roche is seeking a claim whereby
the cobas HPV Test can be used as a first-line primary cervical
screening test. The test utilizes amplification of target DNA by the
polymerase chain reaction and nucleic acid hybridization for the
detection of 14 high risk (HR) HPV types in a single analysis. The test
specifically identifies types HPV 16 and HPV 18 while concurrently
detecting the rest of the high risk types (31, 33, 35, 39, 45, 51, 52,
56, 58, 59, 66, and 68). Per the proposed indication, women who test
negative for high risk HPV types by the cobas HPV Test would be
followed up in accordance with the physician's assessment of screening
and medical history, other risk factors, and professional guidelines.
Women who test positive for HPV genotypes 16 and/or 18 by the cobas HPV
Test would be referred to colposcopy. Women who test high risk HPV
positive and 16/18 negative by the cobas HPV Test (12 other HR HPV
positive) would be evaluated by cervical cytology to determine the need
for referral to colposcopy.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background

material on its Web site prior to the meeting, the background material
will be made publicly available at the location of the advisory
committee meeting, and the background material will be posted on FDA's
Web site after the meeting. Background material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the
appropriate advisory committee meeting link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
March 3, 2014. On March 12, 2014, oral presentations from the public
will be scheduled between approximately 1 p.m. and 2 p.m. Those
individuals interested in making formal oral presentations should
notify the contact person and submit a brief statement of the general
nature of the evidence or arguments they wish to present, the names and
addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before
February 21, 2014. Time allotted for each presentation may be limited.
If the number of registrants requesting to speak is greater than can be
reasonably accommodated during the scheduled open public hearing
session, FDA may conduct a lottery to determine the speakers for the
scheduled open public hearing session. The contact person will notify
interested persons regarding their request to speak by February 25,
2014.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact James Clark,
Committee Management Staff<EMAIL_ADDRESS>or<PHONE_NUMBER> at
least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: January 14, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-00939 Filed 1-17-14; 8:45 am]
BILLING CODE 4160-01-P


Campgrounds Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Rinse food contact surfaces with potable water prior to reuse. Do not use on glasses, dishes, or utensils.

Playground Equipment ( Residential) Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Rinse food contact surfaces with potable water prior to reuse. Do not use on glasses, dishes, or utensils.

2Although the application rate of product is different, the application rate of active ingredient ( as calculated by multiplying the product application rate by the concentration of active ingredient in the product) is approximately 0.96g PHMB per quart of water.

3The application rate for both products is 900 ppm of active ingredient due to differences in the concentration of the active ingredient in the product formulations. 53 Use Site Formulation Application Rate ( Range) 1 No. of Applications Use Limitations Medical premises and equipment Impregnated Wipe ( Reg. 50096 1) 1 wipe lasts 20 uses Hospital Materials Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Rinse food contact surfaces with potable water prior to reuse. Do not use on glasses, dishes, or utensils.

Impregnated Wipe ( Reg. 50096 1) 1 wipe lasts 20 uses Hospital Premises Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Rinse food contact surfaces with potable water prior to reuse. Do not use on glasses, dishes, or utensils.

Human Nursery Equipment Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Rinse food contact surfaces with potable water prior to reuse. Do not use on glasses, dishes, or utensils.

Human Nursery Premises Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Rinse food contact surfaces with potable water prior to reuse. Do not use on glasses, dishes, or utensils. 54 Use Site Formulation Application Rate ( Range) 1 No. of Applications Use Limitations Nursing Home Premises Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Rinse food contact surfaces with potable water prior to reuse. Do not use on glasses, dishes, or utensils.

Dental Offices Ready to Use Solution ( Reg. 71661 1) Thoroughly wet ( saturate) all surfaces for 10 minutes. Rinse food contact surfaces with potable water prior to reuse. Do not use on glasses, dishes, or utensils.

Materials preservatives Adhesives/ Glues ( Aqueous Based)

( Indirect Food Contact) Aqueous Solution ( Reg. 1258

1253) 500 5,000 ppm Aqueous Industrial Chemicals ( Reagents/

Oilin Water Emulsions/ Water in Oil Emulsions/ Textile Spin Finish Lubricants/ Wash Water/ Cellulose Solutions Aqueous Solution ( Reg. 1258

1253) 100 5,000 ppm 55 Use Site Formulation Application Rate ( Range) 1 No. of Applications Use Limitations Cellulosic Materials Aqueous Solution ( Apply by padding,

spraying,

soaking, or exhaustion)

( Reg. 1258

1253) 0.025 2% on dry weight of substrate Industrial Electrocoats ( Resins and Deposition Systems) Aqueous Solution ( Reg. 1258

1253) 1,000 5,000 ppm Household Consumer Products Aqueous Solution ( Reg. 1258

1253) 250 2,500 ppm Leather Products and Hides/ Skins ( Fresh Animal) Aqueous Solution ( Reg. 1258

1253) 15 fl oz. 3 gal [ 1.0 2.6 lbs product per 1,000 lbs hides/ skins] Use prior to or during processing Polymer Latices ( Aqueous Based) ( i. e.

Polyvinyl Acetate/ Alcohol) Aqueous Solution ( Reg. 1258

1253) 500 5,000 ppm 56 Use Site Formulation Application Rate ( Range) 1 No. of Applications Use Limitations Silicone Emulsions/ Dispersions Aqueous Solution ( Reg. 1258

1253) 100 5,000 ppm Slurries ( Aqueous)

( Indirect Food Contact) Aqueous Solution ( Reg. 1258

1253) 500 5,000 ppm Textiles Aqueous Solution ( Apply by padding,

spraying,

soaking, or exhaustion)

( Reg. 1258

1253) 0.025 2% on dry weight of substrate ( 8) Industrial processes and water systems Leather Processing Liquors/ Solutions Aqueous Solution ( Reg. 1258

1253) 100 3,000 ppm 57 Use Site Formulation Application Rate ( Range) 1 No. of Applications Use Limitations Oil Recovery Drilling Muds/ Packer Fluids Aqueous Solution ( Reg. 1258

1253) 3,000 ppm Not for use in oil recovery systems which employ holding ponds for spent liquids. Do not apply in,

over, or near marine and/ or estuarine oil fields.

Workover Fluids Aqueous Solution ( Reg. 1258

1253) 3,000 ppm Not for use in oil recovery systems which employ holding ponds for spent liquids. Do not apply in,

over, or near marine and/ or estuarine oil fields.

95 ppm Slug 47 ppm Weekly Secondary Oil Recovery Injection Water Aqueous Solution ( Reg. 1258

1253) 4 20 ppm Continuous Not for use in oil recovery systems which employ holding ponds for spent liquids. Do not apply in,

over, or near marine and/ or estuarine oil fields.

Apply slug treatment to a point where system will be uniformly mixed. Weekly follows slug treatment when microbial control is evident.

Before continuous treatment, apply a slug treatment.

Swimming pools Swimming Pool Water Systems Ready to Use Solution ( Reg. 1258

1263; 1258

1265; 7124 105;

69461 1; 71864

2; 81002 2) Maintain Concentration of 30 50 ppm Weekly/ As Necessary Cannot use with chlorine or bromine based pool products. 58 Use Site Formulation Application Rate ( Range) 1 No. of Applications Use Limitations Tablets ( Soluble Concentrate)

( Reg. 1258

1275) Maintain Concentration of 6 10 ppm Weekly/ As Necessary Cannot use with chlorine or bromine based pool products.

Hot Tubs/ Spas ( Water Treatment) Ready to Use Solution ( Reg. 1258

1263; 1258

1265; 69461 1;

71864 2) Maintain Concentration of 30 50 ppm Weekly/ As Necessary Cannot use with chlorine or bromine based pool products. 59 Appendix B. Table of Generic Data Requirements and Studies Used to Make the Reregistration Decision Guide to Appendix B Appendix B contains listing of data requirements which support the reregistration for active ingredients within case # 3144 ( PHMB) covered by this RED. It contains generic data requirements that apply to PHMB in all products, including data requirements for which a " typical formulation" is the test substance.

The data table is organized in the following formats:

1. Data Requirement ( Column 1). The data requirements are listed in the order in which they appear in 40 CFR part 158.

The reference numbers accompanying each test refer to the test protocols set in the Pesticide Assessment Guidance, which are available from the National technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 ( 703) 487 4650.

2. Use Pattern ( Column 4). This column indicates the use patterns for which the data requirements apply. The following letter designations are used for the given use patterns.

( 1) Agricultural premises and equipment ( 2) Food handling/ storage establishments premises and equipment ( 3) Commercial, institutional and industrial premises and equipment ( 4) Residential and public access premises ( 5) Medical premises and equipment ( 6) Human water systems ( 7) Materials preservatives ( 8) Industrial processes and water systems ( 9) Antifouling coatings ( 10) Wood preservatives ( 11) Swimming pools ( 12) Aquatic areas 3. Bibliographic Citation ( Column 5). If the Agency has acceptable data in its files, this column list the identify number of each study. This normally is the Master Record Identification ( MRID) number, but may be a " GS" number if no MRID number has been assigned. Refer to the Bibliography appendix for a complete citation of the study. 60 DATA REQUIREMENT CITATION( S)

New Guideline Number Old Guideline Number Study Title Use Pattern MRID Number PRODUCT CHEMISTRY 830.1550 61 1 Product Identity and Composition All 41965401, 42728901 830.1600 830.1620 830.1650 61 2a Starting Materials and Manufacturing Process All 41894001, 41930701 830.1670 61 2b Formation of Impurities All 41965401, 42728903 830.1700 62 1 Preliminary Analysis All 41965401 830.1750 62 2 Certification of Limits All 42728902, 41965401 830.1800 62 3 Analytical Method All 42728902, 41965401 830.6302 63 2 Color All 41966401 830.6303 63 3 Physical State All 41966401 830.6304 63 4 Odor All 41966401 830.7050 None UV/ Visible Absorption All Waived1 830.7200 63 5 Melting Point All 41966401 830.7220 63 6 Boiling Point All 41966401 830.7300 63 7 Density All 41966401 830.7840 830.7860 63 8 Solubility All 41966401 830.7950 63 9 Vapor Pressure All 41966401 830.7370 63 10 Dissociation Constant in Water All 41966401 1 Study waived because the chemical structure shows that it will not absorb in the UV spectral region. 61 DATA REQUIREMENT CITATION( S)

New Guideline Number Old Guideline Number Study Title Use Pattern MRID Number 830.7550 830.7560 830.7570 63 11 Partition Coefficient ( Octanol/ Water) All 41687001 830.7000 63 12 pH All 41966401 830.6313 63 13 Stability All 42728902 830.6314 63 14 Oxidizing/ Reducing Action All Not Applicable 830.6315 63 15 Flammability All Not Applicable 830.6316 63 16 Explodability All Not Applicable 830.6317 63 17 Storage Stability All 42728902 830.7100 63 18 Viscosity All Not Applicable 830.6319 63 19 Miscibility All Not Applicable 830.6320 63 20 Corrosion Characteristics All Not Applicable 830.6321 63 21 Dielectric breakdown voltage All Not Applicable ECOLOGICAL EFFECTS 850.2100 71 1 Avian Acute Oral Toxicity Test All 27491 ( 93191001)

850.2200 71 2 Avian Dietary Toxicity All 41382 ( 93191002)

850.1075 72 1 Fish Acute Toxicity  Freshwater All ACC 234289 ( MRID 77928 and 77929), 43949001 850.1010 72 2 Acute Aquatic Invertebrate Toxicity All ACC 234289 ( MRID 77929)

850.1075 72 3a Acute Estuarine/ Marine Toxicity  Fish 8 Waived2 2 Label precludes use in, over, or near marine and/ or estuarine environments. Therefore, Guidelines 850.1075 and 850.1025 are waived. 62 DATA REQUIREMENT CITATION( S)

New Guideline Number Old Guideline Number Study Title Use Pattern MRID Number 72 3b Acute Estuarine/ Marine Toxicity  Invertebrate ( Mollusk) 8 Waived2 850.1025 72 3c Estuarine/ Marine Toxicity  Invertebrate ( Shrimp) 8 Waived2 TOXICOLOGY 870.1100 81 1 Acute Oral  Rat All 30330 ( 93191005), 44940701,

45916505 870.1200 81 2 Acute Dermal  Rabbit All 65124, 44940702, 45916506 870.1300 81 3 Acute Inhalation  Rat All 44970403 870.2400 81 4 Primary Eye Irritation  Rabbit All 46789, 65120, 44963902, 45916508 870.2500 81 5 Primary Dermal Irritation  Rabbit All 46789, 65120, 44949704, 45916509 870.2600 81 6 Dermal Sensitization All 42674201, 44940705 82 1a 90 Day Feeding Rodent All Waived3 870.3100 82 1b 90 Day Feeding Non Rodent All 53461 870.3200 82 2 21/ 28 Day Dermal Toxicity  Rat All 43047701 870.3250 82 3 90 day Dermal Toxicity  Rodent All Waived4 870.3465 82 4 90 Day Inhalation  Rat All Data gap 870.3700 83 3 Developmental Toxicity All 65131 ( rodent), 429921015 ( rodent), 42865901 ( non rodent)

870.3800 83 4 Reproduction and Fertility Effects  2 Generation Repro All 43617401 3 Study waived because Guideline 83 1a ( Chronic Toxicity Rodent) satisfies this data requirement.

4 Study waived because 80 week dermal cancer study in mice submitted under Guideline 83 2b satisfies requirement.

5 MRID 42992101 is an upgrade to the original study, MRID 65131. 63 DATA REQUIREMENT CITATION( S)

New Guideline Number Old Guideline Number Study Title Use Pattern MRID Number 83 1a Chronic Feeding Toxicity  Rodent 2,3,4,5,7,11 44059301, 44042801 870.4100 83 1b Chronic Feeding Toxicity  Non Rodent ( dog) 2,3,4,5,7,11 43620501 83 2a Oncogenicity  Rat 11 44059301, 44042801 870.4200 83 2b Oncogenicity  Mouse 11 44074201( oral), 93191028 ( dermal),

66475( dermal), 104796 ( dermal)

870.4300 83 5 Combined Chronic Toxicity/ Carcinogenicity 11 44059301 870.5265 84 2 Bacterial Reverse Mutation Assay All 41687004 870.5385 84 2 Micronucleus Assay All 41096901, 41404503 870.5375 84 2 Cytogenic assay with human lymphocytes All 41404501, 42149905 870.5550 84 2 UDS Assay All 41404502, 42149903 870.7485 85 1 General Metabolism 2,3,4,5,7,11 43599901, 43567001, 77926, 86363 870.7600 85 2 Dermal Absorption 11 Waived6 OCCUPATIONAL/ RESIDENTIAL EXPOSURE 875.2800 133 1 Description of Human Activity All Data Gap 875.2400 875.2900 133 3 Dermal Passive Dosimetry 11 44051301 875.2500 875.2900 133 4 Inhalation Passive Dosimetry 11 44051301 875.1200 875.1600 233 Dermal Indoor Exposure All Data Gap 875.1400 875.1600 234 Inhalation Indoor Exposure All Data Gap 6 Study waived because 80 week dermal cancer study submitted under Guideline 83 2b in mice satisfies requirement. 64 DATA REQUIREMENT CITATION( S)

New Guideline Number Old Guideline Number Study Title Use Pattern MRID Number ENVIRONMENTAL FATE 835.2120 161 1 Hydrolysis All 43622301 OTHER DATA REQUIREMENTS Non Guideline Non Guideline Dietary Residues in Food from Treating Countertops with PHMB ( FDA Wipe Study Methodology7) 2,3,4,5 Data Gap 7 FDA, 2003a. " Guidance For Industry: Preparation of Food Contact Notifications and Food Additive Petitions for Food Contact Substances: Chemistry Recommendations. Final Guidance." US Food and Drug Administration. April, 2003. http:// www. cfsan. fda. gov/~ dms/ opa2pmnc. html.

FDA, 2003b. " Sanitizing Solutions: Chemistry Guidelines for Food Additive Petitions." US Food and Drug Administration. January, 1993.

http:// www. cfsan. fda. gov/~ dms/ opa cg3a. html. 65 Appendix C. Technical Support Documents Additional documentation in support of this RED is maintained in the OPP docket, located in Room 119, Crystal Mall # 2, 1801 Bell Street, Arlington, VA. It is open Monday through Friday, excluding legal holidays, from 8: 30 am to 4 pm.

The docket initially contained the August 26, 2004 preliminary risk assessment and the related documents. EPA then considered comments on these risk assessments ( which are posted to the e docket) and revised the risk assessments. The revised risk assessments will be posted in the docket at the same time as the RED.

All documents, in hard copy form, may be viewed in the OPP docket room or downloaded or viewed via the Internet at the following sites:

http:// www. epa. gov/ pesticides/ antimicrobials http:// www. epa. gov/ edockets These documents include:

  Poly( hexamethylenebiguanide) hydrochloride Preliminary Risk Assessment; Notice of Availability, 9/ 10/ 04.   Poly( hexamethylenebiguanide) hydrochloride ( PHMB) Summary, 8/ 30/ 04.   Overview of the PHMB Preliminary Risk Assessment, 8/ 24/ 04.

Preliminary Risk Assessment and Supporting Science Documents:   Poly( hexamethylenebiguanide) hydrochloride ( PHMB): Preliminary Risk Assessment for the Reregistration Eligibility Decision, PC Code 111801, Case 3122, Antimicrobials Division, 8/ 26/ 04.   Product Chemistry Science Chapter on PHMB ( 20% Formulations of Vantocil P and Vantocil IB). PC Code 111801, Case 3122, Antimicrobials Division, 8/ 4/ 04, A. Najm Shamim, Ph. D.   PHMB  2nd Report of the Hazard Identification Assessment Review Committee, TXR No. 0051756, Health Effects Division, 4/ 9/ 03, Jonathan Chen, Ph. D.   Cancer Assessment Document: Evaluation of the Carcinogenic Potential of PHMB, PC Code 111801, Case 3122, TXR No. 0052040, Health Effects Division, 7/ 16/ 03, Jessica Kidwell, Executive Secretary, Cancer Assessment Review Committee.   Poly( hexamethylenebiguanide) hydrochloride ( PHMB): Toxicology Disciplinary Chapter for the Reregistration Eligibility Decision Document, PC Code 111801, Case 3122, Antimicrobials Division, 8/ 26/ 04, Jonathan Chen, Ph. D. and Timothy F. McMahon, Ph. D.   PHMB Dietary Exposure Assessments for the Reregistration Eligibility Decision. PC Code 111801, Case 3122, Antimicrobials Division, 8/ 26/ 04, A. Najm Shamim, Ph. D.   PHMB Occupational/ Residential Exposure Assessment. PC Code 111801, Case 3122, Antimicrobials Division, 8/ 19/ 04, Timothy Leighton, Ph. D.   Health Effects of PHMB in Humans. PC Code 111801, Case 3122, Antimicrobials 66 Division, 8/ 4/ 04, Jonathan Chen, Ph. D.   Environmental Fate Assessment of PHMB for the Reregistration Eligibility Decision ( RED). PC Code 111801, Case 3122, Antimicrobials Division, 8/ 18/ 04, A. Najm Shamim, Ph. D.   Ecological Hazard and Environmental Risk Assessment: Poly( hexamethlenebiguanide) hydrochloride ( PHMB). PC Code 111801, Case 3122, Antimicrobials Division, 8/ 4/ 04, Kathryn Montague, M. S.

Revised Risk Assessment and Supporting Science Documents ( RED Supporting Documents):   Poly( hexamethylenebiguanide) hydrochloride ( PHMB): Risk Assessment for the Reregistration Eligibility Decision, PC Code 111801, Case 3122, Antimicrobials Division, 2/ 14/ 05.   Product Chemistry Science Chapter on PHMB ( 20% Formulations of Vantocil P and Vantocil IB). PC Code 111801, Case 3122, Antimicrobials Division, 8/ 4/ 04, A. Najm Shamim, Ph. D.

  PHMB  2nd Report of the Hazard Identification Assessment Review Committee, TXR No. 0051756, Health Effects Division, 4/ 9/ 03, Jonathan Chen, Ph. D.   Cancer Assessment Document: Evaluation of the Carcinogenic Potential of PHMB, PC Code 111801, Case 3122, TXR No. 0052040, Health Effects Division, 7/ 16/ 03, Jessica Kidwell, Executive Secretary, Cancer Assessment Review Committee.   Poly( hexamethylenebiguanide) hydrochloride ( PHMB): Toxicology Disciplinary Chapter for the Reregistration Eligibility Decision Document, PC Code 111801, Case 3122, Antimicrobials Division, 1/ 18/ 05, Jonathan Chen, Ph. D. and Timothy F. McMahon, Ph. D.   PHMB Dietary Exposure Assessments for the Reregistration Eligibility Decision. PC Code 111801, Case 3122, Antimicrobials Division, 1/ 18/ 05, A. Najm Shamim, Ph. D.   PHMB Occupational/ Residential Exposure Assessment. PC Code 111801, Case 3122, Antimicrobials Division, 2/ 3/ 05, Timothy Leighton, Ph. D. and Cassi Walls, Ph. D.   Health Effects of PHMB in Humans. PC Code 111801, Case 3122, Antimicrobials Division, 8/ 4/ 04, Jonathan Chen, Ph. D.   Environmental Fate Assessment of PHMB for the Reregistration Eligibility Decision ( RED). PC Code 111801, Case 3122, Antimicrobials Division, 8/ 18/ 04, A. Najm Shamim, Ph. D.   Ecological Hazard and Environmental Risk Assessment: Poly( hexamethlenebiguanide) hydrochloride ( PHMB). PC Code 111801, Case 3122, Antimicrobials Division, 11/ 18/ 05, Kathryn Montague, M. S. 67 Appendix D. Citations Considered to be Part of the Data Base Supporting the Reregistration Decision ( Bibliography)

1. MRID Studies MRID# Citation 27491 Beavers, J. B.; Fink, R.; Brown, R. ( 1979) Final Report: Acute Oral LD50 Mallard Duck: Project No. 123 131. ( Unpublished study received Feb 14, 1980 under 10182 19; prepared by Wildlife International, Ltd. in cooperation with Washington State College, submitted by ICI Americas, Inc., Wilmington, Del.; CDL: 241792 A)

30330 Jackson, S. J. ( 1979) Acute Oral and Dermal Toxicity: Report No. CTL/ T/ 1361: Vantocil/ P. ( Unpublished study received Feb 14, 1980 under 10182 19; prepared by Imperial Chemical Industries, Ltd., submitted by ICI Americas, Inc., Wilmington, Del.; CDL: 241790 A)

41382 Beavers, J. B.; Fink, R.; Brown, R. ( 1979) Final Report: Eight Day Dietary LC50  Bobwhite Quail: Project No. 123 129. ( Unpublished study received Feb 14, 1980 under 10182 19; prepared by Wildlife International, Ltd. in cooperation with Washington State College, submitted by ICI Americas, Inc., Wilmington, Del.; CDL: 241792 C)

45698 Brown, D.; Maddock, B. G. ( 1980) Determination of the Acute Toxicity of Vantocil P to Rainbow Trout (~ Salmo gairdneri~): BL/ B/ 2031. ( Unpublished study received Aug 21, 1980 under 10182 19; prepared by Imperial Chemical Industries, Ltd., submitted by ICI Americas, Inc., Wilmington, Del.; CDL: 243099 B)

46789 Imperial Chemical Industries, Limited ( 1966) Antibacterial 9073: Toxicological Properties: Report No. TR/ 558. ( Unpublished study received Feb 6, 1969 under 0H2556; CDL: 221701 I)

53460 Griffiths, D.; Hayes, M. J.; McElligott, T. F. ( 1966) Ninety Day Oral Toxicity of Antibacterial 9073 Albino Rats: Report No. IHR/ 199. ( Unpublished study received Feb 6, 1969 under 0H2556; submitted by Imperial Chemical Industries, Ltd., London, England; CDL: 2217101 J)

53461 Griffiths, D.; Hayes, M. J.; McElligott, T. F. ( 1966) Ninety Day Oral Toxicity of Antibacterial 9073 Beagle Dogs: Report No. IHR/ 202. ( Unpublished study received Feb 6, 1969 under 0H2556; submitted by Imperial Chemical Industries, Ltd., London, England; CDL: 221701 K) 68 65120 Conning, D. N. ( 1966) Antibacterial 9073: Toxicological Properties: Report No. TR/ 558. ( Unpublished study received Mar 10, 1978 under 10182 EX 11; prepared by Imperial Chemical Industries Ltd., England, submitted by ICI Americas, Inc., Wilmington, Del.; CDL: 233267 B)

65124 Trueman, R. W.; Eaton, D. ( 1977) Baquacil SB: Acute Dermal Toxicity and Skin Irritation Effects: Report No. CTL/ T/ 1057. ( Unpublished study received Mar 10, 1978 under 10182 EX 11; prepared by Imperial Chemical Industries Ltd., England, submitted by ICI Americas, Inc., Wilmington, Del.; CDL: 233267 F)

65131 Hodge, M. C. E.; Palmer, S. ( 1976) Baquacil SB: A Teratology Study in the Rat by Dietary Administration: Report No. CTL/ P/ 262. ( Unpublished study received Mar 10, 1978 under 10182 EX 11; submitted by ICI Americas, Inc., Wilmington, Del.; CDL: 233267 M; 233268)

66475 Clapp, M. J. L.; Iswaran, T. J.; Major, P. ( 1977) Polyhexamethylene Biguanide: 80 Week Skin Painting Study in Mice: Report No. CTL/ P/ 331 ( Amended). ( Unpublished study received Mar 10, 1978 under 10182 EX 11; submitted by ICI Americas, Inc., Wilmington, Del.; CDL: 233269 A)

77926 Bratt, H. ( 1977) Vantocil IB: Absorption and Excretion Studies in the Rat: Report No. CTL/ P/ 163B. Interim rept. ( Unpublished study received May 30, 1978 under 10182 19; submitted by ICI Americas, Inc., Wilmington, Del.; CDL: 234289 B)

77928 Hill, R. W.; Maddock, B. G.; Hart, B. ( 1975) Vantocil: Determination of the Acute Toxicity to Rainbow Trout of Vantocil 1B in Freshwater: BL/ B/ 1631. ( Unpublished study received May 30, 1978 under ACC# 234289; prepared by Imperial Chemical Industries, Ltd., England, submitted by ICI Americas, Inc., Wilmington, Del.; CDL: 234289 D)

77929 Buccafusco, R. J.; LeBlanc, G. A. ( 1977) Acute Toxicity of Vantocil^( R) I IB, Mix No. 1857, to Bluegill (~ Lepomis macrochirus~) and the Water Flea (~ Daphnia magna~). ( Unpublished study received May 30, 1978 under ACC# 234289; prepared by EG & G, Bionomics, submitted by ICI Americas, Inc., Wilmington, Del.; CDL: 234289 E)

86362 Trutter, J. A.; Patterson, D. R. ( 1977) 26 week Toxicity Study in Dogs: 20% P. H. M. B. Final rept. ( Unpublished study received Mar 10, 1978 under 10182 EX 11; prepared by Hazleton Laboratories America, Inc., submitted by ICI Americas, Inc., Wilmington, Del.; CDL: 233270 A)

86363 Bratt, H. ( 1975) Vantocil IB: Absorption and Excretion Studies in the Rat: Report No. CTL/ P/ 163B. Interim rept. ( Unpublished study received Mar 10, 1978 under 10182 EX 11; submitted by ICI Americas, Inc., Wilmington, Del.; CDL: 233270 B) 69 104796 ICI Americas, Inc. ( 1975) Polyhexamethylene Biguanide: 80 Week Skin Painting Study in Mice: Appendix B: Pathology Individual Animal Data: Report No. CTL/ P/ 331. ( Unpublished study received Sep 27, 1978 under 10182 EX 11; CDL: 235604 A)

41096901 Randall, V.; Beck, S. ( 1989) Vantocil IB: An Evaluation in the Mouse Micronucleus Test: Report No. CTL/ P/ 2436. Unpublished study prepared by ICI Ltd., Central Toxicology Laboratory. 37 p.

41404501 Howard, C. ( 1989) Vantocil IB: An Evaluation in the in vitro Cytogenetic Assay in Human Lymphocytes: Lab Project ID: CTL/ P/ 2582. Unpublished study prepared by ICI Central Toxicology Laboratory. 28 p.

41404503 Randall, V.; Beck, S. ( 1989) Vantocil IB: An Evaluation in the Mouse Micronucleus Test Addendum: Lab Project ID: CTL/ P/ 2436. Unpublished study prepared by ICI Central Toxicology Laboratory. 7 p.

41687004 Callander, R. ( 1989) Vantocil IB: An Evaluation in the Salmonella Mutation Assay: Lab Project Number: CTL/ P/ 2406. Unpublished study prepared by ICI Central Toxicology Laboratory. 39 p.

42587501 Popendorf, W.; Selim, M.; Kross, B. ( 1992) Chemical Manufacturers Association Antimicrobial Exposure Assessment Study: Second Replacement to MRID 41761201: Lab Project Number: Q626. Unpublished study prepared by The University of Iowa. 316 p.

42674201 Duerden, L. ( 1993) Polyhexamethylene Biguanide: Skin Sensitisation to the Guinea Pig of a 20% Aqueous Solution: Lab Project Number: CTL/ P/ 3889: GG5741: GG5694. Unpublished study prepared by ZENECA Central Toxicology Lab. 27 p.

42865901 Brammer, A. ( 1993) Polyhexamethylene Biguanide: Developmental Toxicity Study in the Rabbit: Lab Project Number: CTL/ P/ 3997: RB0614. Unpublished study prepared by Zeneca Central Toxicology Lab. 352 p.

43567001 Lythgoe, R.; Howard, E.; Prescott, E. ( 1995) PHMB: Absorption, Distribution, Metabolism and Excretion Following Single Oral Dosing ( 20mg/ kg) in the Rat: Lab Project Number: CTL/ P/ 4537: UR0360. Unpublished study prepared by Zeneca Central Toxicology Lab. 82 p.

43599901 Lythgoe, R.; Howard, E. ( 1995) PHMB: Bioavailability Following Dietary Administration in the Rat: Lab Project Number: CTL/ P/ 4595: UR0468. Unpublished study prepared by Zeneca Central Toxicology Lab. 41 p. 70 43617401 Milburn, G. ( 1995) Polyhexamethylene Biguanide: Multigeneration Study in the Rat: Lab Project Number: CTL/ P/ 4455: RR0621/ F0: RR0621/ F1. Unpublished study prepared by Zeneca Central Toxicology Lab. 1985 p.

43620501 Horner, S. ( 1995) Polyhexamethylene Biguanide: 1 Year Dietary Toxicity Study in Dogs: Lab Project Number: CTL/ P/ 4488: PD0947. Unpublished study prepared by Zeneca Central Toxicology Lab. 542 p.

43622301 Evans, K.; Beaumont, G.; Williams, D. ( 1995) PHMB Hydrolysis Study for EPA Registration: Project 302: Lab Project Number: RD012064B. Unpublished study prepared by Zeneca Specialties. 33 p.

43949001 Penwell, A.; Roberts, G. ( 1995) PHMB: Acute Toxicity to Rainbow Trout Oncorhynchus mykiss: Lab Project Number: BL5506/ B: X839/ B. Unpublished study prepared by Zeneca Ltd. 30 p.

44042801 Busey, W. ( 1996) Polyhexamethylene Biguanide ( PHMB): Two Year Feeding Study in Rats: Pathology Working Group Peer Review of Proliferative Vascular Lesions in Male and Female Rats: Lab Project Number: PR0936: CTL/ C/ 3172: Y00156/ 008. Unpublished study prepared by Experimental Pathology Labs., Inc. 67 p. { Relates to L0000061}.

44046301 Dugard, P.; Mawdsley, S. ( 1982) ( Carbon 14) Polyhexamethylene Biguanide ( PHMB): Absorption Through Human Epidermis and Rat Skin in vitro: Lab Project Number: CTL/ R/ 579. Unpublished study prepared by Imperial Chemical Industries Ltd., Central Toxicology Lab. 36 p.

44051301 Burt, M. ( 1996) Assessment of Worker and Postapplicator Exposure to PHMB Used in Pools and Spas: Lab Project Number: JCS/ 1. Unpublished study prepared by Zeneca Specialties. 41 p.

44059301 Horner, S. ( 1996) Polyhexamethylene Biguanide: Two Year Feeding Study in Rats: Lab Project Number: CTL/ P/ 4663: PR0936. Unpublished study prepared by Zeneca Central Toxicology Lab. 3015 p. Relates to L0000061.

44074201 Milburn, G. ( 1996) Polyhexamethylene Biguanide: Two Year Oncogenic Study in Mice: Lab Project Number: CTL/ P/ 4649: PM0937. Unpublished study prepared by Zeneca Central Toxicology Lab. 2348 p.

45187701 Backhouse, B. ( 2000) Health Risk Assessment for PHMB in 100% Cotton Textile Applications Systemic Toxicity by an Infant Sucking a Textile ( Initially Unwashed, Subsequently Washed): Lab Project Number: SENS10D. Unpublished study prepared by Avecia Limited. 7 p. 71 45710801 Piccirillo, V. ( 2002) Evaluation of the Weight of Evidence for the Carcinogenic Potential of PHMB: Lab Project Number: VJP 7172 02 1. Unpublished study prepared by Avecia, Inc. 11 p.

45710802 Mann, P. ( 2002) Polyhexamethylene Biguanide ( PHMB): 2 Year Oncogenic Study in Mice: Lab Project Number: PM0937: 698 001. Unpublished study prepared by Experimental Pathology Laboratories, Inc. 63 p. { OPPTS 870.4300}

45710803 Freemantle, M. ( 2002) Polyhexamethylene Biguanide ( PHMB): Two Year Oncogenic Study in Mice: Statistical Analysis of the Results from the Pathology Working Group Peer Review of Vascular Lesions in Male and Female Mice: Lab Project Number: AP 7. Unpublished study prepared by Syngenta Central Toxicology Laboratory. 17 p.

45710804 Brown, E. ( 2002) Historical Control Data for Occurrence of Hemangiosarcoma ( Angiosarcoma) in C57BL/ 10J/ CD 1 A1pk Mice: Lab Project Number: AP 1. Unpublished study prepared by Syngenta Central Toxicology Laboratory. 7 p.

45710805 Brown, E. ( 2002) Exceedance of the Maximum Tolerated Dose at the Highest Tested Dose of PHMB in Mice: Lab Project Number: AP 2. Unpublished study prepared by ChemReg International, LLC. 5 p.

45710807 Brown, E. ( 2002) Potential Carcinogenicity from Dermal Applications of PHMB: Lab Project Number: AP 4. Unpublished study prepared by ChemReg International, LLC. 10 p.

45710808 Brown, E. ( 2002) Historical Control Data for Occurrence of Hemangiosarcoma ( Angiosarcoma) in A1pk: ApfSD Wistar Rats: Lab Project Number: AP 5. Unpublished study prepared by Syngenta Central Toxicology Laboratory. 8 p.

93191001 Burt, M. ( 1990) ICI Americas Inc. Phase 3 Summary of MRID 00027491. Acute Oral LD50  Mallard Duck, Baquacil Mix # 5889, Final Report: Project No. 123 131. Prepared by Wildlife International Ltd. 10 p.

93191002 Burt, M. ( 1990) ICI Americas Inc. Phase 3 Summary of MRID 00041382. Eight Day Dietary LC50  Bobwhite Quail Baquacil Mix # 5889, Final Report: Project No. 123 129. Prepared by Wildlife International Ltd. 11 p.

93191004 Adams, D. ( 1990) ICI Americas Inc. Phase 3 Summary of MRID 00045698. Vantocil P: Determination of the Acute Toxicity to Rainbow Trout Salmo gairdneri: Report No. BL B 2031; Study No. G184 B. Prepared by ICI Brixham Laboratory. 14 p. 72 2. Open Literature American Chemistry Council ( ACC). 2002. An Analysis of the Training Patterns and Practices of Competitive Swimmers. Alexandria, Virginia: Prepared by Richard Reiss. Sciences International, Inc.

Brunsman, L. L. 2002. PHMB Qualitative Risk Assessment Based On 1977 SPF Alderley Park Mouse Dermal Study, and 1996 C57B1/ 10JfCD 1/ Alpk Mouse and 1996 Alpk: APfSD Wistar Rat Dietary Studies. TXR No. 0051368.

Dykstra, W. 1978. Baquacil Swimming Pool Sanitizer ( containing Poly ( hexamethylene biguanide hydrochloride). Experimental Use Permit Application for the Evaluation of Baquacil in Recreational Swimming Pools. 10182 EUP 11. Caswell # 676. Report No. 003801.

IT Environmental Programs, Inc. 1991. Chemical Engineering Branch Manual for the Preparation of Engineering Assessments. Contract No. 68 D8 0112. Work Assignment P3 7. U. S. Environmental Protection Agency. Office of Toxic Substances.

McMahon, T. 1995. Polyhexamethylene Biguanide ( PHMB, Baquacil): Review of a Mutagenicity Study Submitted by the Registrant. Report No. 011380.

McMahon, T. 1997. Vantocil IB ® ( Baquacil): Review of Mutagenicity Data. DP Barcode: D240678.

Megosh, LC, Hu, J, Geroge K, O'Brien TG. 2002. Genetic control of polyamine dependent susceptibility to skin carcinogenesis. Genomics 79: 505 512.

Milovic V, Turchanowa L. 2003. Polyamines and colon cancer. Biochemical Society Transactions 31: 381 383.

Pletcher, J. M. 2002. Memorandum on Pathology Working Group Peer Review of Proliferative Vascular Lesions in Male and Female Mice. October 28, 2002. TXR No. 0052033.

Pletcher, J. M. 2003. Memorandum on Pathology Working Group Peer Review of Proliferative Vascular Lesions in Male and Female Rats. July 16, 2003. TXR No. 0052000.

US EPA. 1997a. Standard Operating Procedures ( SOPs) for Residential Exposure Assessments. Contract No. 68 W6 0030. Prepared by the Residential Exposure Assessment Work Group. Office of Pesticide Programs, Health Effects Division and Versar. July 1997.

US EPA. 1997b. Exposure Factors Handbook. National Center for Environmental Assessment, Office of Research and Development. 73 US EPA. 1997c. Surrogate Exposure Guide: Estimates of Worker Exposure from the Pesticide Handler Exposure Database, Version 1.1. May 1997.

US EPA. 2000. Standard Operating Procedures ( SOPs) for Residential Exposure Assessments. Office of Pesticide Programs, Health Effects Division. April 2000.

US EPA 2001b. Review of a Health Risk Assessment for PHMB ( Vantocil IB) used on 100% Cotton Textile Application  Systemic Toxicity by an Infant Sucking Textile. Memorandum for Siroos Mostaghimi, Ph. D. to Adam Heyward. January 3, 2001.

Versar. 2003. User's Manual Swimmer Exposure Assessment Model ( SWIMODEL) Version 3.0. Prepared for the US EPA Antimicrobials Division. November 2003.

3. Website References FDA, 2003a. " Guidance For Industry: Preparation of Food Contact Notifications and Food Additive Petitions for Food Contact Substances: Chemistry Recommendations. Final Guidance." US Food and Drug Administration. April, 2003. http:// www. cfsan. fda. gov/~ dms/ opa2pmnc. html. Last accessed June 9, 2003.

FDA, 2003b. " Sanitizing Solutions: Chemistry Guidelines for Food Additive Petitions." US Food and Drug Administration. January, 1993. http:// www. cfsan. fda. gov/~ dms/ opacg3a html. Last accessed June 9, 2003.

USEPA, 1999. " Available Information on Assessing Exposure from Pesticides, A User's Guide." US Environmental Protection Agency, Office of Pesticide Programs. June 21, 1999. http:// www. epa. gov/ fedrgstr/ EPA PEST/ 2000/ July/ Day 12/ 6061. pdf. Last accessed June 9, 2003.

USEPA, 2001a. " General Principles for Performing Aggregate Exposure and Risk Assessments." US Environmental Protection Agency, Office of Pesticide Programs. November 28, 2001. http:// www. epa. gov/ pesticides/ trac/ science/ aggregate. pdf.

USEPA, 2004. Overview of the Ecological Risk Assessment Process in the Office of Pesticide Programs U. S. Environmental Protection Agency  Endangered and Threatened Species Effects Determinations, Appendix A, Section IIB, pg. 81. US Environmental Protection Agency. January 24, 2004. http:// www. epa. gov/ oppfead1/ endanger/ consultation/ ecorisk overview. pdf. 74 Appendix E. Generic Data Call In The Agency intends to issue a Generic Data Call In at a later date. See Chapter V of the PHMB RED for a list of studies that the Agency plans to require. 75 Appendix F. Product Specific Data Call In The Agency intends to issue a Product Specific Data Call In at a later date. 76 Appendix G. Batching of PHMB Products for Meeting Acute Toxicity Data Requirements for Reregistration In an effort to reduce the time, resources and number of animals needed to fulfill the acute toxicity data requirements for reregistration of products containing PHMB as an active ingredient, the Agency has batched products which can be considered similar for purposes of acute toxicity. Factors considered in the sorting process include each product's active and inert ingredients ( identity, percent composition and biological activity), type of formulation ( e. g., emulsifiable concentrate, aerosol, wettable powder, granular), and labeling ( e. g., signal word, use classification, precautionary labeling). Note that the Agency is not describing batched products as " substantially similar," since they may not have similar use patterns.

Using available information, batching has been accomplished by the process described in the preceding paragraph. Notwithstanding the batching process, the Agency reserves the right to require, at any time, acute toxicity data for an individual product should the need arise.

Registrants of products within a batch may choose to cooperatively generate, submit or cite a single battery of six acute toxicological studies to represent all the products within that batch. It is the registrants' option to participate in the process with all other registrants, only some of the other registrants, or only their own products within a batch, or to generate all the required acute toxicological studies for each of their own products. If a registrant chooses to generate the data for a batch, he/ she must use one of the products within the batch as the test material. If a registrant chooses to rely upon previously submitted acute toxicity data, he/ she may do so provided that the data base is complete and valid by today's standards ( see partial list of acceptance criteria attached), the formulation tested is considered by EPA to be similar for acute toxicity, and the formulation has not been significantly altered since submission and acceptance of the acute toxicity data. The Agency must approve any new or canceled formulations ( that were presented to the Agency after the publication of the RED) before data derived from them can be used to cover other products in a batch. Regardless of whether new data is generated or existing data is referenced, registrants must clearly identify the test material by EPA Registration Number. If more than one confidential statement of formula ( CSF) exists for a product, the registrant must indicate the formulation actually tested by identifying the corresponding CSF.

In deciding how to meet the product specific data requirements, registrants must follow the directions given in the Data Call In Notice and its attachments appended to the RED. The DCI Notice contains two response forms which are to be completed and submitted to the Agency within 90 days of receipt. The first form, " Data Call In Response," asks whether the registrant will meet the data requirements for each product. The second form, " Requirements Status and Registrant's Response," lists the product specific data required for each product, including the standard six acute toxicity tests. A registrant who wishes to participate in a batch must decide whether he/ she will provide the data or depend on someone else to do so. If a registrant supplies the data to support a batch of products, he/ she must select one of the following options: Developing Data ( Option 1), Submitting an Existing Study ( Option 4), Upgrading an Existing Study ( Option 5) or Citing an Existing Study ( Option 6). If a registrant depends on another's 77 data, he/ she must choose among: Cost Sharing ( Option 2), Offers to Cost Share ( Option 3) or Citing an Existing Study ( Option 6). If a registrant does not want to participate in a batch, the choices are Options 1, 4, 5 or 6. However, a registrant should know that choosing not to participate in a batch does not preclude other registrants in the batch from citing his/ her studies and offering to cost share ( Option 3) those studies.

If a registrant would like to have the batching status of a product reconsidered, he/ she must submit detailed information on the product, including a detailed rationale for the inclusion of the product into a batch. An MSDS for each " inert" ingredient should be included where possible. A current version of the Confidential Statement of Formula ( CSF) is to be included in the submission. However, registrants and manufacturers should realize that the more unusual their formulation is, the less likely it is to be able to batch that product.

Seventeen products were found which contain PHMB as an active ingredient. These products have been placed into three batches and a " No Batch" category in accordance with the active and inert ingredients and type of formulation. The following bridging strategies may be employed:

° Batch 3:   For eye irritation and skin sensitization data, Registration Numbers 72992 2 and 72992 8 may only cite their own studies or those of 72992 2.   For eye irritation and skin sensitization data, Reg. No. 72992 3 and 72992 7 may cite each other's studies but not 72992 2 or 72992 8 studies.   For all other studies, each product must cite its own data or data from Reg. No. 72992 2.

° No Batch: Each product in this batch should generate its own data ( or cite its own pre existing data if it exists and meets current Agency standards).

Table: PHMB Batching, Case 3122 Batch EPA Reg. No. Active Ingredients 1258 1275 PHMB 96.3%

BATCH 1 1258 1277 PHMB 96.3%

1258 1252 PHMB 20%

1258 1253 PHMB 20%

1258 1263 PHMB 20%

7124 105 PHMB 20%

69461 1 PHMB 20%

71864 2 PHMB 20% BATCH 2 81002 2 PHMB 20% 78 72992 2 PHMB 0.25%

Bronopol* 0.26%

* CASRN 52 51 7, EPA code 216400 72992 3 PHMB 0.09%

Bronopol* 0.09%

* CASRN 52 51 7, EPA code 216400 72992 7 PHMB 0.061%

Bronopol* 0.06%

* CASRN 52 51 7, EPA code 216400 BATCH 3 As indicated in the above introductory comments, the four products listed here are batched together with the following limitations:

1. For eye irritation and skin sensitization data, Registration Numbers 72992 2 and 72992 8 may only cite their own studies or those of 72992 2.

2. For eye irritation and skin sensitization data, Reg. No. 72992 3 and 72992 7 may cite each other s studies but not 72992 2 or 72992 8 studies.

3. For all other studies, each product must cite its own data or data from Reg. No.

72992 2. 72992 8 PHMB 0.1%

Bronopol* 0.104%

* CASRN 52 51 7, EPA code 216400 1258 1265 PHMB 20%

5813 75 PHMB 0.1%

50096 1 PHMB 3.17%

ADBAC* 7.11%

* Alkyl ( 50% C14, 40% C12, 10% C16)

dimethyl benzyl ammonium chloride,

CASRN 68424 85 1, EPA code 069105 NO BATCH Each product in this batch should generate its own data ( or cite its own pre existing data if it exists and meets current Agency standards).

71661 1 PHMB 0.56%

Silver 0.0095 Please note that while products may have the same percent active ingredient as another product, the composition of their inert ingredients may vary greatly. 79 MINIMUM ACUTE TOXICITY ACCEPTANCE CRITERIA 1 Does the study report clearly identify the test material? That is, is the test material identified by EPA Registration Number, product name, or, is the product listed as technical grade?

2 Does the report state that the study was conducted in concurrence with the ( 1984) 40 CFR § 160.12?

3 Is the test species identified?

4 Are the test animals the proper weight? ( Rats approximately 200 300 grams, rabbits approximately 2.0  3.0 kg.)

5 Acute oral, dermal and inhalation toxicity: Did the observation period last for 14 days, or, until the test subjects appeared normal?

6 Primary eye irritation: Did the observation period continue for 21 days, or, until all irritation subsided? Studies displaying excessive irritation ( toxicity category I) may be stopped before 21 days.

7 Primary skin irritation: Did the observation period continue for 14 days, or, until all irritation subsided? Studies displaying excessive irritation ( toxicity category I) may be stopped before 14 days.

8 Acute inhalation toxicity: Were the test subjects exposed to the material for at least 4 hours ( if there was no mortality during the exposure)?

9 Acute inhalation toxicity: Was particle size determined at least twice during the exposure? Was the MMAD between 1 and 4 microns ( micrometers)?

10 Acute inhalation toxicity: Was the particle concentration determined at least twice during the study?

Studies that do not meet each ( 1 10) of the criteria listed above will be rejected. Please be informed that EPA's guidelines change from year to year. A study that was accepted 25 or more years ago may not be currently acceptable.

Please refer to the following documents for more information. 1. Health Effects Test Guidelines, Series 870, EPA 712 C 98 189, August 1998.

2. Conduct of Acute Toxicity Studies, EPA 737 R 97 002, September 1997. 80 Appendix H. List of All Registrants Sent the Data Call In A list of registrants sent the data call in will be posted at a later date. 81 Appendix I. List of Available Related Documents and Electronically Available Forms Pesticide Registration Forms are available at the following EPA internet site: http:// www. epa. gov/ opprd001/ forms/ .

Pesticide Registration Forms ( These forms are in PDF format and require the Acrobat reader)

Instructions 1. Print out and complete the forms. ( Note: Form numbers that are bolded can be filled out on your computer then printed.)

2. The completed form( s) should be submitted in hardcopy in accord with the existing policy.

3. Mail the forms, along with any additional documents necessary to comply with EPA regulations covering your request, to the address below for the Document Processing Desk.

DO NOT fax or e mail any form containing ` Confidential Business Information' or ` Sensitive Information.'

If you have any problems accessing these forms, please contact Nicole Williams at ( 703) 308 5551 or by e mail at williams. nicole@ epamail. epa. gov.

The following Agency Pesticide Registration Forms are currently available via the internet at the following locations: 8570 1 Application for Pesticide Registration/ Amendment http:// www. epa. gov/ opprd001/ forms/ 8570 1. pdf 8570 4 Confidential Statement of Formula http:// www. epa. gov/ opprd001/ forms/ 8570 4. pdf 8570 5 Notice of Supplemental Registration of Distribution of a Registered Pesticide Product http:// www. epa. gov/ opprd001/ forms/ 8570 5. pdf 8570 17 Application for an Experimental Use Permit http:// www. epa. gov/ opprd001/ forms/ 8570 17. pdf 8570 25 Application for/ Notification of State Registration of a Pesticide To Meet a Special Local Need http:// www. epa. gov/ opprd001/ forms/ 8570 25. pdf 8570 27 Formulator's Exemption Statement http:// www. epa. gov/ opprd001/ forms/ 8570 27. pdf 8570 28 Certification of Compliance with Data Gap Procedures http:// www. epa. gov/ opprd001/ forms/ 8570 28. pdf 8570 30 Pesticide Registration Maintenance Fee Filing http:// www. epa. gov/ opprd001/ forms/ 8570 30. pdf 8570 32 Certification of Attempt to Enter into an Agreement with other Registrants for Development of Data http:// www. epa. gov/ opprd001/ forms/ 8570 32. pdf 8570 34 Certification with Respect to Citations of Data ( in PR Notice 98 5) http:// www. epa. gov/ opppmsd1/ PR_ Notices/ pr98 5. pdf 8570 35 Data Matrix ( in PR Notice 98 5) http:// www. epa. gov/ opppmsd1/ PR_ Notices/ pr98 5. pdf 8570 36 Summary of the Physical/ Chemical Properties ( in PR Notice 98 1) http:// www. epa. gov/ opppmsd1/ PR_ Notices/ pr98 1. pdf 8570 37 Self Certification Statement for the Physical/ Chemical Properties ( in PR Notice 98 1) http:// www. epa. gov/ opppmsd1/ PR_ Notices/ pr98 1. pdf 82 Pesticide Registration Kit www. epa. gov/ pesticides/ registrationkit/.

Dear Registrant:

For your convenience, we have assembled an online registration kit that contains the following pertinent forms and information needed to register a pesticide product with the U. S. Environmental Protection Agency's Office of Pesticide Programs ( OPP):

1. The Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) and the Federal Food, Drug and Cosmetic Act ( FFDCA) as Amended by the Food Quality Protection Act ( FQPA) of 1996.

2. Pesticide Registration ( PR) Notices a. 83 3 Label Improvement Program  Storage and Disposal Statements b. 84 1 Clarification of Label Improvement Program c. 86 5 Standard Format for Data Submitted under FIFRA d. 87 1 Label Improvement Program for Pesticides Applied through Irrigation Systems ( Chemigation)

e. 87 6 Inert Ingredients in Pesticide Products Policy Statement f. 90 1 Inert Ingredients in Pesticide Products; Revised Policy Statement g. 95 2 Notifications, Non notifications, and Minor Formulation Amendments h. 98 1 Self Certification of Product Chemistry Data with Attachments ( This document is in PDF format and requires the Acrobat reader.)

Other PR Notices can be found at http:// www. epa. gov/ opppmsd1/ PR_ Notices.

3. Pesticide Product Registration Application Forms ( These forms are in PDF format and will require the Acrobat reader.)

a. EPA Form No. 8570 1, Application for Pesticide Registration/ Amendment b. EPA Form No. 8570 4, Confidential Statement of Formula c. EPA Form No. 8570 27, Formulator's Exemption Statement d. EPA Form No. 8570 34, Certification with Respect to Citations of Data e. EPA Form No. 8570 35, Data Matrix 83 4. General Pesticide Information ( Some of these forms are in PDF format and will require the Acrobat reader.)

a. Registration Division Personnel Contact List b. Biopesticides and Pollution Prevention Division ( BPPD) Contacts c. Antimicrobials Division Organizational Structure/ Contact List d. 53 F. R. 15952, Pesticide Registration Procedures; Pesticide Data Requirements ( PDF format)

e. 40 CFR Part 156, Labeling Requirements for Pesticides and Devices ( PDF format)

f. 40 CFR Part 158, Data Requirements for Registration ( PDF format)

g. 50 F. R. 48833, Disclosure of Reviews of Pesticide Data ( November 27, 1985)

Before submitting your application for registration, you may wish to consult some additional sources of information. These include:

1. The Office of Pesticide Programs' Web Site 2. The booklet " General Information on Applying for Registration of Pesticides in the United States", PB92 221811, available through the National Technical Information Service ( NTIS) at the following address:

National Technical Information Service ( NTIS) 5285 Port Royal Road Springfield, VA 22161 The telephone number for NTIS is ( 703) 605 6000. Please note that EPA is currently in the process of updating this booklet to reflect the changes in the registration program resulting from the passage of the FQPA and the reorganization of the Office of Pesticide Programs. We anticipate that this publication will become available during the Fall of 1998.

3. The National Pesticide Information Retrieval System ( NPIRS) of Purdue University's Center for Environmental and Regulatory Information Systems. This service does charge a fee for subscriptions and custom searches. You can contact NPIRS by telephone at ( 765) 494 6614 or through their Web site.

4. The National Pesticide Telecommunications Network ( NPTN) can provide information on active ingredients, uses, toxicology, and chemistry of pesticides. You can contact NPTN by telephone at ( 800) 858 7378 or through their Web site: ace. orst. edu/ info/ nptn.

The Agency will return a notice of receipt of an application for registration or amended registration, experimental use permit, or amendment to a petition if the applicant or petitioner 84 encloses with his submission a stamped, self addressed postcard. The postcard must contain the following entries to be completed by OPP:

Date of receipt EPA identifying number Product Manager assignment Other identifying information may be included by the applicant to link the acknowledgment of receipt to the specific application submitted. EPA will stamp the date of receipt and provide the EPA identifying File Symbol or petition number for the new submission. The identifying number should be used whenever you contact the Agency concerning an application for registration, experimental use permit, or tolerance petition. To assist us in ensuring that all data you have submitted for the chemical are properly coded and assigned to your company, please include a list of all synonyms, common and trade names, company experimental codes, and other names which identify the chemical ( including " blind" codes used when a sample was submitted for testing by commercial or academic facilities). Please provide a CAS number if one has been assigned.


[Federal Register Volume 80, Number 225 (Monday, November 23, 2015)]
[Notices]
[Pages 72964-72965]
[FR Doc No: 2015-29763]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[EL16-14-000]

Indiana Municipal Power Agency; Notice of Filing

    Take notice that on November 13, 2015, Indiana Municipal Power
Agency submitted an application for proposed revenue requirement for
reactive supply service from its 24.95 percent interest in Gibson Unit
No. 5.

    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 5 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5:00 p.m. Eastern Time on December 4, 2015.

    Dated: November 16, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-29763 Filed 11-20-15; 8:45 am]
 BILLING CODE 6717-01-P