[Federal Register Volume 76, Number 193 (Wednesday, October 5, 2011)]
[Proposed Rules]
[Pages 61647-61649]
[FR Doc No: 2011-25725]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 174 and 180

[EPA-HQ-OPP-2011-0082; FRL-8890-5]

Receipt of Several Pesticide Petitions Filed for Residues of
Pesticide Chemicals in or on Various Commodities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of filing of petitions and request for comment.

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SUMMARY: This document announces the Agency's receipt of several
initial filings of pesticide petitions requesting the establishment or
modification of regulations for residues of pesticide chemicals in or
on various commodities.

DATES: Comments must be received on or before November 4, 2011.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number and the pesticide petition number (PP) of interest as shown
in the body of this document, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to the docket ID number and the
pesticide petition number of interest as shown in the body of this
document. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: A contact person, with telephone
number and e-mail address, is listed at the end of each pesticide
petition summary. You may also reach each contact person by mail at
Registration Division (7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of

this action to a particular entity, consult the person listed at the
end of the pesticide petition summary of interest.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low-income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts or environmental effects from exposure to the pesticides
discussed in this document, compared to the general population.

II. What action is the Agency taking?

    EPA is announcing its receipt of several pesticide petitions filed
under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA),
21 U.S.C. 346a, requesting the establishment or modification of
regulations in 40 CFR part 174 or part 180 for residues of pesticide
chemicals in or on various food commodities. The Agency is taking
public comment on the requests before responding to the petitioners.
EPA is not proposing any particular action at this time. EPA has
determined that the pesticide petitions described in this document
contain the data or information prescribed in FFDCA section 408(d)(2);
however, EPA has not fully evaluated the sufficiency of the submitted
data at this time or whether the data support granting of the pesticide
petitions. After considering the public comments, EPA intends to
evaluate whether and what action may be warranted. Additional data may
be needed before EPA can make a final determination on these pesticide
petitions.
    Pursuant to 40 CFR 180.7(f), a summary of each of the petitions
that are the subject of this document, prepared by the petitioner, is
included in a docket EPA has created for each rulemaking. The docket
for each of the petitions is available on-line at http://www.regulations.gov.
    As specified in FFDCA section 408(d)(3), (21 U.S.C. 346a(d)(3)),
EPA is publishing notice of the petition so that the public has an
opportunity to comment on this request for the establishment or
modification of regulations for residues of pesticides in or on food
commodities. Further information on the petition may be obtained
through the petition summary referenced in this unit.

New Tolerances

    1. PP 1E7890. (EPA-HQ-OPP-2011-0758). Interregional Research
Project Number 4 (IR-4), Rutgers, The State University of New Jersey,
500 College Road East, Suite 201-W., Princeton, NJ 08540, requests to
establish tolerances in 40 CFR part 180 for residues of the herbicide
sulfentrazone (N-[2,4-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-
methyl-5-oxo-1H-1,2,4-triazol-1-yl]phenyl]-methanesulfonamide) and its
metabolites 3-hydroxymethyl-sulfentrazone (N-[2,4-dichloro-5-[4-
(difluoromethyl)-4,5-dihydro-3-hydroxymethyl-5-oxo-1H-1,2,4-triazol-1-
yl]phenyl]methanesulfonamide) and 3-desmethyl sulfentrazone (N-[2,4-
dichloro-5-[4-(difluoromethyl)-4,5-dihydro-5-oxo-1H-1,2,4-triazol-1-
yl]phenyl]methanesulfonamide), in or on rhubarb at 0.2 parts per
million (ppm); turnip, roots at 0.2 ppm; turnip, tops at 0.7 ppm; and
sunflower subgroup 20B at 0.2 ppm; ``Tolerances with regional
registrations'' in or on wheat, forage at 0.45 ppm (Pacific Northwest
only); wheat, hay at 0.20 ppm (Pacific Northwest only); wheat, grain at
0.20 ppm (Pacific Northwest only); wheat, straw at 1.4 ppm (Pacific
Northwest only); and cowpea, succulent at 0.15 ppm (Tennessee only).
There is a practical analytical method for detecting and measuring
levels of sulfentrazone and its metabolites in or on food with a limit
of quantitation that allows monitoring of food with residues at or
above the levels set or proposed in the tolerances. The analytical
enforcement method for sulfentrazone was used with minor modification
that eliminated several clean-up and derivatization steps that was
required for gas chromatography with mass selective detection (GC/MSD)
but not for liquid chromatography with tandem mass spectrometric
detection (LC/MS/MS). The analytical method for sulfentrazone involves
separate analyses for parent and its metabolites. The parent is
analyzed by evaporation and reconstitution of the sample prior to
analysis by LC/MS/MS GC/electron capture detector (ECD). The
metabolites samples were refluxed in the presence of acid and cleaned
up with solid phase extraction prior to analysis by LC/MS/MS. Contact:
Laura Nollen,<PHONE_NUMBER>, e-mail address<EMAIL_ADDRESS>    2. PP 1F7872. (EPA-HQ-OPP-2011-0743). Agriphar S.A., c/o Ceres
International, LLC., 1087 Heartsease Drive, West Chester, PA 19382,
requests to establish tolerances in 40 CFR part 180 for residues of the
fungicide dodine (dodecylguanidine acetate), in or on stone fruits
(Group 12) at 5 parts per million (ppm); tree nuts (Group 14, except
almond hulls) at 0.3 ppm; and almond hulls at 12 ppm. An adequate
enforcement method using GC/mass spectrometry detection (MSD), Method
45137, is available for determining dodine residues in or on plant
commodities. Concerning tree crops, a method using LC/MS/MS;
METH1595.02, after the samples were extracted with methanol, was

submitted. Adequate data collection method validation, independent
laboratory validation (ILV), and radio-validation data for the method
has been submitted. Since there is no reasonable expectation of finding
residues of dodine in livestock or poultry, no analytical method for
animal tissues is required. Contact: Tamue L. Gibson,<PHONE_NUMBER>,
e-mail address<EMAIL_ADDRESS>    3. PP 1F7887. (EPA-HQ-OPP-2011-0741). Cytec Industries, Inc., 5
Garret Mountain Plaza, Woodland Park, NJ 07424, requests to establish
tolerances in 40 CFR part 180 for residues of phosphine, in or on
asparagus; cherimoya; dates, fresh; figs, fresh; globe artichokes;
pawpaws; pineapple, water chestnuts and watercress, and for all fresh
fruit and vegetable crop groups (including berry and small fruit;
citrus fruit; pome fruit; stone fruit; herbs and spices; Brassica leafy
vegetables; leafy vegetables; bulb vegetables; cucurbits; fruiting
vegetables except cucurbits; legume vegetables, except soybeans;
foliage of legume vegetables; root and tuber group; and root and tuber
leaves group) at 0.01 ppm. The PAM Vol. II lists, under aluminum
phosphide, a colorimetric method level of detection (LOD = 0.01) and a
gas liquid chromatography (GLC) method with a flame photometric
detection (LOD = 0.001 ppm) as Method A and B, respectively, for the
enforcement of tolerances. The residue of concern is phosphine. It is
noted that Method A, remains a lettered method because of variable
recoveries observed in an Agency method try-out. However, the method
has been determined to be acceptable for enforcement because phosphine
is highly reactive, and finite residues are not expected. Data
submitted in support of the established tolerances were collected by
one of these two methods. Because phosphine is an inorganic compound,
recovery of residues using FDA Multiresidue Protocols is not expected,
and the requirement for such data has been waived by the Agency.
Contact: Gene Benbow,<PHONE_NUMBER>, e-mail address:
<EMAIL_ADDRESS>    4. PP 1F7897. (EPA-HQ-OPP-2009-0677). Arysta LifeScience, North
America, LLC., 15401 Weston Parkway, Suite 150, Cary, NC 27513,
requests to establish a tolerance in 40 CFR part 180 for residues of
the fungicide fluoxastrobin, (1E)-[2-[[6-(2-chlorophenoxy)-5-fluoro-4-
pyrimydinyl]oxy]phenyl] (5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-
methyloxime, and its Z-isomer, (1Z)-[2-[[6-(2-chlorophenoxy)-5-fluoro-
4-pyrimydinyl]oxy]phenyl] (5,6-dihydro-1,4,2-dioxazin-3-yl)methanone O-
methyloxime, in or on rice, grain at 6.0 ppm. Adequate analytical
methodology is available for enforcement purposes. The method comprises
microwave solvent extraction followed by a solid phase extraction
clean-up and quantification by high performance liquid chromatography
with tandem mass spectrometric detection (HPLC/MS/MS). The individual
detector responses for measured E- and Z-isomers is summed to give
total residue. Contact: Heather A. Garvie,<PHONE_NUMBER>, e-mail
address<EMAIL_ADDRESS>
Amended Tolerance

    PP 1E7890. (EPA-HQ-OPP-2011-0758). Interregional Research Project
Number 4 (IR-4), Rutgers, The State University of New Jersey, 500
College Road East, Suite 201-W., Princeton, NJ 08540, requests to amend
the current tolerances in 40 CFR 180.498 for residues of the herbicide
sulfentrazone (N-[2,4-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-
methyl-5-oxo-1H-1,2,4-triazol-1-yl]phenyl]-methanesulfonamide) and its
metabolites 3-hydroxymethyl-sulfentrazone (N-[2,4-dichloro-5-[4-
(difluoromethyl)-4,5-dihydro-3-hydroxymethyl-5-oxo-1H-1,2,4-triazol-1-
yl]phenyl]methanesulfonamide) and 3-desmethyl sulfentrazone (N-[2,4-
dichloro-5-[4-(difluoromethyl)-4,5-dihydro-5-oxo-1H-1,2,4-triazol-1-
yl]phenyl]methanesulfonamide), in or on bean, lima, succulent at 0.15
ppm by removing the tolerance from the table in Section (a)(2) and
adding the tolerance to Section (c) Tolerances with regional
registrations. Upon approval of the aforementioned tolerance under
``New Tolerances'', the petition additionally proposes to remove the
established tolerance in or on the raw agricultural commodity
sunflower, seed at 0.2 ppm. Contact: Laura Nollen,<PHONE_NUMBER>, e-
mail address<EMAIL_ADDRESS>
New Tolerance Exemptions

    1. PP 1E7903. (EPA-HQ-OPP-2011-0736). ISK Biosciences Corporation,
7470 Auburn Road, Suite A, Concord, OH 44077, requests to establish an
exemption from the requirement of a tolerance for residues of D-mannose
(CAS No. 3458-28-4) under 40 CFR 180.920 when used as an inert
ingredient (sequestrant) in pesticide formulations applied pre-harvest
to all raw agricultural commodities. The petitioner believes no
analytical method is needed because this information is not required
for the establishment of a tolerance exemption. Contact: Mark Dow,
(703) 305-5533, e-mail address<EMAIL_ADDRESS>    2. PP 1E7909. (EPA-HQ-OPP-2011-0732). Momentive Performance
Materials, 22 Corporate Woods Blvd., Albany, NY 12211, requests to
establish an exemption from the requirement of a tolerance for residues
of 2-Propenoic acid, 2-methyl-, polymer with butyl 2-propenoate and
ethenylbenzene (CAS No. 25036-16-2) under 40 CFR 180.960 when used as a
pesticide inert ingredient as a sticker in pesticide formulations
without limitation. The petitioner believes no analytical method is
needed because this information is not required for the establishment
of a tolerance exemption. Contact: Elizabeth Fertich,<PHONE_NUMBER>,
e-mail address<EMAIL_ADDRESS>
List of Subjects

    Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.

    Dated: September 28, 2011.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2011-25725 Filed 10-4-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 133 (Friday, July 11, 2014)]
[Notices]
[Pages 40109-40111]
[FR Doc No: 2014-16238]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0829]

Draft Guidance for Industry on Reporting Drug Sample Information
Under Section 6004 of the Affordable Care Act; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Reporting Drug
Sample Information Under Section 6004 of the Affordable Care Act.'' On
March 23, 2010, the Patient Protection and Affordable Care Act (ACA)
was signed into law. The Secretary of Health and Human Services has
delegated authority to FDA to issue guidance to identify the
information to be submitted under section 6004 and oversee and make
arrangements for the collection of such information. FDA is issuing
this draft guidance to provide information to assist persons submitting
drug sample information under ACA section 6004, and to advise industry
of an updated compliance policy. This draft guidance revises the draft
compliance policy guide issued on April 3, 2012.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by October 9, 2014. Submit either electronic or written
comments concerning the proposed collection of information by September
9, 2014.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communications, Division of Drug Information,
Center for Drug Evaluation and Research, Food and Drug Administration,
10001 New Hampshire Ave., Hillandale Bldg., 4th floor, Rm. 4147, Silver
Spring, MD 20993, or the Office of Communication, Outreach and
Development, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993-0002. The draft guidance may also be obtained
by mail by calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Karen Rothschild, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 4282, Silver Spring, MD 20903, 301-796-
3689, or Stephen Ripley, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20903,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Reporting Drug Sample Information Under Section 6004 of the
Affordable Care Act.'' On March 23, 2010, the ACA was signed into law.
Among its many provisions, section 6004 of the ACA amended the Social
Security Act (SSA) by adding section 1128H (42 U.S.C. 1320a-7i). This
new section required the submission of certain drug sample information
to FDA not later than April 1 of each year, beginning April 1, 2012.
    In particular, section 6004 requires reporting about drug sample
requests and distributions from manufacturers and authorized
distributors of record (ADRs) of applicable drugs (prescription drugs),
which are defined in the ACA as drugs subject to section 503(b) of the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 353(b))
for which payment is available under Title XVIII or the SSA or a State
plan under Title XIX or XXI of the SSA (or a waiver of such plan). (See
42 U.S.C. 1320a-7i(b)(1).) The Secretary has delegated authority to FDA
to issue guidance identifying the information to be submitted under
section 6004, and to oversee and arrange for the collection of such
information.
    Section 6004 is not part of the Prescription Drug Marketing Act
(PDMA) but must be read together with that act. Two of the terms used
in section 6004 are defined by reference to the PDMA. In addition, the
PDMA and its implementing regulations at 21 CFR part 203, subpart D
(beginning at Sec.  203.30 (21 CFR 203.30)) require the collection and
maintenance of information that must be submitted under section 6004.
For example, Sec.  203.38(b) requires that a manufacturer or ADR
maintain records of drug sample distribution for all samples
distributed under section 503(d)(2) or 503(d)(3) of the FD&C Act that
are sufficient to permit tracking of sample units to the point of the
licensed practitioner. Under section 6004, manufacturers and ADRs must
now submit much of the same information, aggregated as specified, to
FDA.
    Another example of how the PDMA and section 6004 are complementary
is that the PDMA requires manufacturers and ADRs to collect signatures
to ensure that drug samples are distributed on the request of
authorized persons and that their receipt is accounted for by persons
authorized to take responsibility for them. The purpose of this
requirement is to ensure a tight chain of custody, which is why no
person other than the practitioner or a specified designee (i.e., not a
common carrier) may sign for receipt of drug samples. The requirement
in section 6004 to report drug sample requests and distributions for
each drug, aggregated by signature, is to ensure that FDA has the
information needed to demonstrate compliance with this important PDMA
provision.
    In the Federal Register of April 3, 2012 (77 FR 20025), FDA issued
a draft guidance for industry entitled ``Compliance Policy on Reporting
Drug Sample Distribution Information Under the Affordable Care Act,''
concerning section 6004. In that draft guidance, FDA explained that the
Electronic Submissions Gateway (the Gateway) was available and ready to
receive submissions of drug sample information as required by section
6004. That guidance also stated FDA's temporary compliance policy with
regard to those submissions, and FDA's intent to issue subsequent
guidance with details to better assist persons submitting drug sample
information under section 6004 and to advise industry of an updated
compliance policy. FDA received comments on the guidance and on the use
of the Gateway to submit the drug sample information required by
section 6004. After carefully considering submitted comments, FDA has
revised the draft guidance, adding more substantive information and
announcing an updated compliance policy, and is reissuing it as a draft
to facilitate public comment.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on reporting
drug sample information under section 6004 of the ACA. It does not
create or confer any rights for or on any person and does not operate
to bind FDA or the public. An alternative approach may be used if such
approach satisfies the requirements of the applicable statutes and
regulations.

II. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.
3501-3520), Federal Agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information that
they conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA, 44 U.S.C. 3506(c)(2)(A), requires Federal Agencies to provide a
60-day notice in the Federal Register for each proposed collection of
information before submitting the collection to OMB for approval. To
comply with this requirement, FDA is publishing this notice of the
proposed collection of information set forth in this document.
    With respect to the collection of information associated with this
draft guidance, FDA invites comments on the following topics: (1)
Whether the proposed information collected is necessary for the proper
performance of

FDA's functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimated burden of the proposed
information collected, including the validity of the methodology and
assumptions used; (3) ways to enhance the quality, utility, and clarity
of the information collected; and (4) ways to minimize the burden of
information collected on the respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
    Under section 6004 of the ACA, manufacturers and ADRs must submit
the following drug sample information to FDA each year: (1) The
identity and quantity of drug samples requested; (2) the identity and
quantity of drug samples distributed; (3) the name, address,
professional designation, and signature of any person who makes or
signs for the request; and (4) any other category of information
determined appropriate by the Secretary. The draft guidance clarifies
the specific information that should be submitted under this provision
and the manner in which that information should be submitted.
    The draft guidance states that FDA's Gateway became available for
drug sample reporting under 6004 in March 2012, and that FDA intends to
continue the use of the Gateway for this purpose. The Gateway accepts
submissions in XML format. Technical specifications for the data type
and size for submitting each of the items listed previously may be
found in the ACA Industry Submission Specifications User Guide,
available at: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/UCM297610.pdf.
    The Gateway requests that manufacturers and ADRs provide the
following information, which is sufficient to comply with the reporting
requirements set forth in section 6004 of the ACA:
     The year the sample was distributed to the provider;
     the type of business (i.e., either manufacturer or
distributor);
     the business name of the manufacturer or distributor that
distributed the drug sample;
     the trade name and dosage of the drug sample distributed;
     the total quantity of the drug requested by the
practitioner during the calendar year;
     the total quantity of the drug distributed to the
practitioner during the calendar year;
     the first name, last name, and middle initial of the
practitioner;
     the practitioner's designation (i.e., M.D., D.O., P.A., or
more);
     the street number, street name, city, state, and ZIP code
address of the practitioner;
     an electronic affirmation that a signed written request
for drug samples was received by the manufacturer or ADR from the
licensed practitioner and is available to FDA upon request;
     an electronic affirmation that a signature of the
requesting practitioner, or appropriate designee, acknowledging receipt
of drug samples has been received by the manufacturer or ADR and is
available to FDA upon request;
     the first name, last name, and middle initial of a
practitioner's designee; and
     the address, including street number, street, city, state,
and ZIP code of the designee.
    Based on the current number of submissions since the enactment of
section 6004 of the ACA, we estimate that annually a total of
approximately 120 to 250 manufacturers or ADRs (``number of
respondents'' in table 1) will submit the drug sample information
specified, resulting in approximately 120 to 250 annual submissions
(``total annual responses'' in table 1). We also estimate that
preparing and submitting this information to FDA will take
approximately 500 to 600 hours for each manufacturer or ADR (``hours
per response'' in table 1). We base the burden hour estimate on
information we obtained from two manufacturers who have submitted the
drug sample information since the enactment of section 6004 of the ACA.
We are using the upper end of these ranges to calculate the burden in
table 1, and the burden hour estimate includes the time that may be
needed to submit any followup or additional information to FDA. In
addition, for purposes of this notice, FDA assumes that only
manufacturers will submit the required information on behalf of all
samples distributed, thereby excluding the need for ADRs to do so.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                      Section 6004 of the ACA                           Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Submission of drug sample information..............................             250                1              250              600          150,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

III. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.

    Dated: July 8, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-16238 Filed 7-10-14; 8:45 am]
BILLING CODE 4164-01-P


#THIS SCRIPT CALCULATES THE PROBABILITY A SYSTEM HAS TREATMENT CHANGE                	  #
#FOR NTNCWS ONLY                                                                          #
#CREATED BY TOM BENEKE (THE CADMUS GROUP) 05/30/2018									  #
###########################################################################################

#import libraries
library(plyr)
library(stringr)

#set working directory
setwd("C:/Users/thomas.beneke/Desktop/ChangeSourceTreatment_05302018 - NTNCWS")

#read in source data
#this is a CSV version of Laura's "tblWSF-Treat" table in the "ChangeTreat-QA" Access database
wsf.df <- read.csv("tblWSF-Treat.csv", stringsAsFactors=FALSE, header=FALSE)
colnames(wsf.df) <- c("PWSID","FacilityID","IsSourceInd","Active_YN","FacilityDeadline","DeactiveDate","FacilityType","WaterType","Availability",
						"SellerPWSID","SellerTreatment","TreatProcess","TreatObj","TreatID","TreatCode","TreatPID","WaterTypeCode","ReportedYear","SourceCode")

#read in community water system table
#this is a CSV version of Laura's "tblC_NTNC" table in the "ChangeInTreat-QA" Access database
ntncws.df <- read.csv("tblC_NTNC.csv", stringsAsFactors=FALSE, header=TRUE)
ntncws.df$PWSID <- ntncws.df$PWS.ID

#read in size category sorting CSV
sort.ord <- read.csv("SortSizeCategories.csv", stringsAsFactors = FALSE, header=TRUE)

#read in pwsids that were already included in source change counts/probabilities
src.chng <- read.csv("Unique_PWSIDs_SourceChange.csv", stringsAsFactors = FALSE, header = TRUE)

#join cws data to wsf dataframe & remove unnecessary columns
wsf.ntncws <- join(wsf.df, ntncws.df, by=c('PWSID'), type='left', match='all')
wsf.ntncws <- wsf.ntncws[,c("PWSID","FacilityID","PWS.Type","TreatCode","TreatPID","CCT_YN","GW.or.SW","Size.Category","IsSourceInd","ReportedYear","SourceCode","Availability")]

#select only non-transient non-community water systems and add "points" field
wsf.ntncws <- wsf.ntncws[wsf.ntncws$PWS.Type == "Non-Transient non-community system" & wsf.ntncws$Availability != "Emergency" & is.na(wsf.ntncws$PWS.Type) == FALSE,]
wsf.ntncws <- wsf.ntncws[wsf.ntncws$PWSID %in% ntncws.df$PWSID == TRUE,]
wsf.ntncws$Points <- 1

#add unique identifier for Treat Code ID - Process Code ID combination
wsf.ntncws$TID_PID <- paste0(wsf.ntncws$TreatCode,"_",wsf.ntncws$TreatPID)
wsf.ntncws <- wsf.ntncws[wsf.ntncws$PWSID %in% src.chng$PWSID == FALSE,]

#aggregate counts by PWSID, source type, and year, for each year
yr13 <- aggregate(Points ~ PWSID + ReportedYear, data = wsf.ntncws[wsf.ntncws$ReportedYear == 2013 & wsf.ntncws$TreatCode != "-" & wsf.ntncws$TreatCode != "",], "sum")
yr14 <- aggregate(Points ~ PWSID + ReportedYear, data = wsf.ntncws[wsf.ntncws$ReportedYear == 2014 & wsf.ntncws$TreatCode != "-" & wsf.ntncws$TreatCode != "",], "sum")
yr15 <- aggregate(Points ~ PWSID + ReportedYear, data = wsf.ntncws[wsf.ntncws$ReportedYear == 2015 & wsf.ntncws$TreatCode != "-" & wsf.ntncws$TreatCode != "",], "sum")
yr16 <- aggregate(Points ~ PWSID + ReportedYear, data = wsf.ntncws[wsf.ntncws$ReportedYear == 2016 & wsf.ntncws$TreatCode != "-" & wsf.ntncws$TreatCode != "",], "sum")

#create empty dataframe to append counts by year to
pws <- data.frame(Obj_ID = seq(1:length(unique(wsf.ntncws$PWSID))),PWSID = unique(wsf.ntncws$PWSID))

#merge in each year's counts of wells
pws <- merge(pws,yr13[,c(1,3)],by="PWSID",all=TRUE)
pws <- merge(pws,yr14[,c(1,3)],by="PWSID",all=TRUE)
pws <- merge(pws,yr15[,c(1,3)],by="PWSID",all=TRUE)
pws <- merge(pws,yr16[,c(1,3)],by="PWSID",all=TRUE)

#remove unnecessary columns
pws <- pws[,c(1,3,4,5,6)]
colnames(pws) <- c("PWSID","y13","y14","y15","y16")

#change NAs to 0 for numeric calculations
pws$y13[is.na(pws$y13)==TRUE] <- 0
pws$y14[is.na(pws$y14)==TRUE] <- 0
pws$y15[is.na(pws$y15)==TRUE] <- 0
pws$y16[is.na(pws$y16)==TRUE] <- 0

#identify year sequences with a change
pws$cnt_delta_1314 <- 0
pws$cnt_delta_1415 <- 0
pws$cnt_delta_1516 <- 0
pws$cnt_delta_1314[pws$y14 > pws$y13] <- 1
pws$cnt_delta_1415[pws$y15 > pws$y14] <- 1
pws$cnt_delta_1516[pws$y16 > pws$y15] <- 1

#join size category, source type, and cct designation back into dataframe
pws <- join(pws, ntncws.df[,c(37,23,8,12)][ntncws.df$PWS.Type == "Non-Transient non-community system" & is.na(ntncws.df$PWS.Type) == FALSE,], by=c('PWSID'), type='left', match='all')
pws$CCT_YN[pws$CCT_YN == 1] <- "Y"
pws$CCT_YN[pws$CCT_YN == 0] <- "N"

#remove rows for PWS IDs that were already counted in the source change probabilities
pws <- pws[pws$PWSID %in% src.chng$PWSID == FALSE,]

#write CSV of systems with a treatment change
pws.chng <- pws
pws.chng$changecount <- rowSums(pws.chng[,(6:8)], na.rm=TRUE)
pws.chng <- pws.chng[,c(1,12)][pws.chng$changecount >=1,]
pws.chng <- pws.chng[duplicated(pws.chng)==FALSE,]
write.csv(pws.chng, "Unique_PWSIDs_TreatChange.csv", row.names=FALSE)

#add counts of number of system changes by year
prob1314 <- aggregate(cnt_delta_1314 ~ CCT_YN + Size.Category + GW.or.SW, data = pws, "sum")
prob1415 <- aggregate(cnt_delta_1415 ~ CCT_YN + Size.Category + GW.or.SW, data = pws, "sum")
prob1516 <- aggregate(cnt_delta_1516 ~ CCT_YN + Size.Category + GW.or.SW, data = pws, "sum")
probs <- prob1314
probs$cnt_delta_1415[match(probs$CCT_YN,prob1415$CCT_YN) & match(probs$Size.Category,prob1415$Size.Category) & match(probs$GW.or.SW,prob1415$GW.or.SW)] <- prob1415$cnt_delta_1415[match(probs$CCT_YN,prob1415$CCT_YN) & match(probs$Size.Category,prob1415$Size.Category) & match(probs$GW.or.SW,prob1415$GW.or.SW)]
probs$cnt_delta_1516[match(probs$CCT_YN,prob1516$CCT_YN) & match(probs$Size.Category,prob1516$Size.Category) & match(probs$GW.or.SW,prob1516$GW.or.SW)] <- prob1516$cnt_delta_1516[match(probs$CCT_YN,prob1516$CCT_YN) & match(probs$Size.Category,prob1516$Size.Category) & match(probs$GW.or.SW,prob1516$GW.or.SW)]

#add counts of all pws systems by size category,cct,and source water type
pws.unique <- ntncws.df[,c(37,3,8,12,23)][duplicated(ntncws.df[,c(37,3,8,12,23)])==FALSE & ntncws.df$PWS.Type == "Non-Transient non-community system",]
colnames(pws.unique) <- c("PWSID","PWS.Type","Size.Category","GW.or.SW","CCT")
pws.unique$CCT[pws.unique$CCT == 0] <- "N"
pws.unique$CCT[pws.unique$CCT == 1] <- "Y"
pws.unique$Points <- 1
all.sys <- aggregate(Points ~ CCT + Size.Category + GW.or.SW, data = pws.unique, "sum")
all.sys$UnqID <- paste0(all.sys$CCT,"_",all.sys$Size.Category,"_",all.sys$GW.or.SW)

#add unique id and join to table of all system counts by category
probs$UnqID <- paste0(probs$CCT_YN,"_",probs$Size.Category,"_",probs$GW.or.SW)
probs <- join(probs, all.sys[,c(5,4)], by=c('UnqID'), type='left', match='all')
probs$Points[is.na(probs$Points)==TRUE] <- 0
probs <- probs[,c(1:6,8)]
colnames(probs) <- c("CCT_YN","SizeCat","GW_SW","cnt_delta_1314","cnt_delta_1415","cnt_delta_1516","cnt_all_pws")

#calculate probabilities
probs$prob1314 <- round(probs$cnt_delta_1314/probs$cnt_all_pws,2)
probs$prob1415 <- round(probs$cnt_delta_1415/probs$cnt_all_pws,2)
probs$prob1516 <- round(probs$cnt_delta_1516/probs$cnt_all_pws,2)
probs$prob_avg <- round((probs$prob1314 + probs$prob1415 + probs$prob1516)/3,2)

#sort probabilities according to SDWIS format
probs$SortOrd <- sort.ord$SortOrder[match(probs$SizeCat,sort.ord$SizeCat)]
probs <- probs[order(probs$GW_SW,probs$SortOrd),]

#write to file
write.csv(probs, "Probability_TreatmentChange__NTNCWS_053018.csv", row.names=FALSE, na="")


[Federal Register Volume 80, Number 132 (Friday, July 10, 2015)]
[Notices]
[Page 39821]
[FR Doc No: 2015-16856]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-75359; File No. SR-CBOE-2015-045]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Designation of Longer Period for Commission
Action on Proposed Rule Change Relating to Rule 6.53C and Complex
Orders on the Hybrid System

July 6, 2015.
    On May 12, 2015, Chicago Board Options Exchange, Incorporated (the
``Exchange'' or ``CBOE'') filed with the Securities and Exchange
Commission (``Commission''), pursuant to Section 19(b)(1) of the
Securities Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to modify Rule 6.53C, Complex
Orders on the Hybrid System, to give the Exchange the flexibility to
distinguish between Professional and non-Professional orders for the
purposes of determining eligibility for COA. The proposed rule change
was published for comment in the Federal Register on May 27, 2015.\3\
On June 3, 2015, CBOE filed Amendment No.1 to the proposed rule
change.\4\ The Commission received no comment letters regarding the
proposed rule change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 75003 (May 20,
2015), 80 FR 30306.
    \4\ Amendment No. 1 to the proposed rule change amended the
statutory basis and burden on competition sections of the Form 19b-4
and Exhibit 1 regarding distinguishing between Professional and non-
Professional orders for purposes of determining eligibility for COA.
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \5\ provides that within 45 days of the
publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
45th day for this filing is July 11, 2015.
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    The Commission is extending the 45-day time period for Commission
action on the proposed rule change. The Commission finds that it is
appropriate to designate a longer period within which to take action on
the proposed rule change so that it has sufficient time to consider the
proposed rule change, as modified by Amendment No. 1.
    Accordingly, pursuant to Section 19(b)(2) of the Act \6\ and for
the reasons stated above, the Commission designates August 25, 2015, as
the date by which the Commission should either approve or disapprove,
or institute proceedings to determine whether to disapprove, the
proposed rule change.
---------------------------------------------------------------------------

    \7\ 17 CFR 200.30-3(a)(31).
    \6\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
Brent J. Fields,
Secretary.
[FR Doc. 2015-16856 Filed 7-9-15; 8:45 am]
 BILLING CODE 8011-01-P