[Federal Register Volume 81, Number 52 (Thursday, March 17, 2016)]
[Notices]
[Pages 14439-14440]
[FR Doc No: 2016-06052]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2015-0841; FRL-9941-93]

Request for Applications; Third-Party Chemical/Product Profilers
for the Safer Choice Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Safer Choice Program reduces pollution and potential risk
at its source by setting criteria that product manufacturers must meet
to qualify to use the Safer Choice label. The Safer Choice label helps
consumers, businesses, and purchasers find products with ingredients
that perform well and are safer for human health and the environment.
To earn the Safer Choice label, products and their ingredients must
meet the established Safer Choice Standard and safer chemical criteria.
Third-party profilers (TPP) review the candidate's products against
Safer Choice standards and criteria, collect performance information,
and develop chemical profiles. EPA is seeking additional third-party
profilers to help the Safer Choice Program meet the growing consumer
demand for safer products carrying the Safer Choice label. Entities
that are interested in serving as Safer Choice third-party profilers
should submit an application for EPA consideration. Qualified
applicants will be asked to sign a memorandum of understanding (MOU),
formalizing their commitment to support the Safer Choice Program's
human and environmental health protection mission.

DATES: Applications may be submitted at any time; however, to be
considered for qualification as a third-party profiler in 2016,
applications must be received by May 16, 2016.

ADDRESSES: Submit your application identified by docket identification
(ID) number EPA-HQ-OPPT-2015-0841, by one of following methods:
     Mail: Safer Choice TPP Application, c/o Abt Associates,
Inc., Attn: Klara Zimmerman, 4550 Montgomery Avenue, Suite 800 North,
Bethesda, MD 20814-5341.
     Phone:<PHONE_NUMBER>.
     Docket: Submit to the docket ID number EPA-HQ-OPPT-2015-
0841.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please contact Tony Thompson
(FOR FURTHER INFORMATION CONTACT). Additional instructions on
commenting or visiting the docket, along with more information about
dockets generally is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For technical information contact:
Tony Thompson, Chemistry, Economics and Sustainable Strategies
Division, Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

    To help the Safer Choice program meet the growing consumer demand
for safer products carrying the Safer Choice label, EPA is actively
soliciting applications for additional Safer Choice third-party
profilers. Entities that are interested in serving as a Safer Choice
third-party profiler should review the Safer Choice standards and
criteria and other program materials available at http://www.epa.gov/saferchoice to determine whether they should apply.
    For a candidate to qualify and fully participate in the Safer
Choice Program, Safer Choice expects and TPPs should address how they
would approach or undertake each of the following activities:
    1. Supporting the Safer Choice Program. Safeguard and uphold the
integrity, quality, and trustworthiness of the Safer Choice product and
chemical-evaluation processes, program, and label, including
development of strong and effective working relationships with the
Safer Choice staff.
    2. Meeting and Maintaining the TPP Provisions in the Safer Choice
Standard. Satisfy the provisions of the Safer Choice Standard, section
7--``Profiler Requirements,'' which include technical competence in
chemical hazard and fate reviews; staffing with experts in the various
profiling disciplines; facility with toxicological models and
estimation tools; program managerial skills; credibility and good
standing; and success at a pilot review that

simulates an actual product evaluation. (See the Safer Choice Standard
at http://www2.epa.gov/saferchoice/safer-choice-standard.)
    3. Following the Procedures in the Safer Choice TPP Handbook. Use
the Third-Party Profiler Handbook/Guidance Manual to inform its
profiling activities, including, for example, searching the approved
set of data sources; digesting the key, distinguishing hazard data; and
preparing a dossier on each chemical ingredient in a candidate product.
    Beyond regular oversight, the TPP will conduct annual partner
surveillance, including triennial on-site audits, to ensure compliance
with program requirements. (See the Third- Party Profiler Handbook;
contact Tony Thompson at<EMAIL_ADDRESS>or<PHONE_NUMBER> for
details.)
    4. Submitting to Performance Review. In addition to regular
feedback and recommendations from Safer Choice staff, engage in annual
performance reviews, and once every 5 years, a full performance
evaluation, which will culminate in a Safer Choice decision on whether
the TPP retains its status as a qualified TPP.
    5. Adopting and Using the Safer Choice Data System. Use the Safer
Choice data system (known as the Safer Choice Community) to manage all
Safer Choice product review and partnership activities, including
purchase and maintenance of the necessary computer hardware and system
licenses. (For more information, see the TPP Handbook.)
    6. Performing Supplemental Duties. Fulfill other requests and
functions related to its TPP duties that may arise from time to time,
as needed.
    7. Adhering to Good Business Practices. Demonstrate and follow good
business practices in dealing with companies working with Safer Choice.
Good business practices include: Offering open access to your services
to legitimate potential clients; adopting and implementing customer
service standards; and avoiding potential conflicts of interest.
    8. Signing a Memorandum of Understanding. Qualified applicants will
be asked to sign a MOU, formalizing their commitment to serve as a TPP
and support the Safer Choice Program's human and environmental health
protection mission. (See the boilerplate MOU in the docket ID number
EPA-HQ-OPPT-2015-0841.)

II. Instructions for Applicants

A. How to Submit an Application

    Applicants for Safer Choice Third Party Profiler must complete an
application form, available in the docket ID number EPA-HQ-OPPT-2015-
0841. To be considered in the 2016 selection cycle, completed
applications must be submitted to Safer Choice via one of the means
listed under ADDRESSES and by the deadline listed under DATES indicated
in this notice.

B. Requirements for Submitting Business Proprietary Information

    Clearly mark the part or all of the information that you claim to
be business proprietary. In addition to one complete version of the
application that includes information claimed as proprietary, a copy of
the application that does not contain the proprietary information must
be submitted. Information marked as business proprietary will not be
disclosed except in accordance with the procedures set forth in 40 CFR
part 2.

III. Selection of Safer Choice Third-Party Profilers

    Safer Choice will review and evaluate all applications based on the
TPP qualifications enumerated in this notice. From the applications
submitted for the 2016 TPP cycle, the program will select up to two
best-qualified candidates to participate in trial product reviews.
After successful completion of these reviews--during which the program
will assist the candidate in orienting to the process and gaining
competency--the candidate will be a qualified Safer Choice TPP. The new
TPP will be asked to sign the Safer Choice-TPP memorandum of
understanding and, following signature, may accept clients and begin
its service to the program.
    The quality and integrity of the Safer Choice label rests on active
program engagement with and oversight of our profilers. Safer Choice
plans to add up to two new TPPs this year, doubling its pool of
profilers, based on the program's ability to assimilate, train, and
oversee the new TPPs while maintaining its other program functions.
Safer Choice will continually evaluate its ability to bring on
additional TPPs.
    All qualified TPPs will be listed in and accessible via the Safer
Choice Community, the data system product manufacturers use to apply
for the Safer Choice label.

    Authority:  15 U.S.C. 2601 et seq.

    Dated: March 9, 2016.
Wendy C. Hamnett,
Director, Office of Pollution Prevention and Toxics.
[FR Doc. 2016-06052 Filed 3-16-16; 8:45 am]
 BILLING CODE 6560-50-P


Page 1 of 3 FIFRA SCIENTIFIC ADVISORY PANEL ( SAP) OPEN MEETING November 30  December 1, 2004 FIFRA SAP WEB SITE http:// www. epa. gov/ scipoly/ sap/ OPP Docket Telephone: ( 703) 305 5805 Docket Number: OPP 2004 0320 TUESDAY, NOVEMBER 30, 2004 Holiday Inn Rosslyn at Key Bridge 1900 North Fort Myer Drive Arlington, VA 22209 ( 703) 807 2000 DIMETHOATE: ISSUES RELATED TO HAZARD AND DOSE RESPONSE ASSESSMENT

8: 30 A. M. Introduction and Identification of Panel Members  Stephen M. Roberts, Ph. D. ( FIFRA SAP Chair)

8: 40 A. M. Administrative Procedures by Designated Federal Official  Ms. Myrta R. Christian

8: 45 A. M. Welcome  Mr. Joseph J. Merenda, Jr. ( Director, Office of Science Coordination and Policy, EPA)

8: 50 A. M. Opening Remarks  Randolph Perfetti, Ph. D. ( Health Effects Division, Office of Pesticide Programs, EPA)

8: 55 A. M. Introduction and Background  Diana Locke, Ph. D. ( Health Effects Division, Office of Pesticide Programs, EPA)

9: 05 A. M. PMRA/ EPA Collaboration  Ms. Cheryl Chaffey ( Pest Management Regulatory Agency, Canada)

9: 15 A. M. Hazard Characterization: Pup Mortality and Cholinesterase Inhibition Results  Kathleen Raffaele, Ph. D. ( Health Effects Division, Office of Pesticide Programs, EPA)

10: 00 A. M. BREAK

10: 15 A. M. Benchmark Dose Analyses  Mr. Philip Villanueva ( Health Effects Division, Office of Pesticide Programs, EPA)

10: 45 A. M. Integration of Hazard and Dose Response Analyses  Kathleen Raffaele, Ph. D. ( Health Effects Division, Office of Pesticide Programs, EPA)

12: 00 P. M. LUNCH

1: 00 P. M. Public Comments

3: 00 P. M. BREAK

3: 15 P. M. Public Comments ( continued)

5: 00 P. M. ADJOURNMENT Page 2 of 3 FIFRA SCIENTIFIC ADVISORY PANEL ( SAP) OPEN MEETING November 30  December 1, 2004 FIFRA SAP WEB SITE http:// www. epa. gov/ scipoly/ sap/ OPP Docket Telephone: ( 703) 305 5805 Docket Number: OPP 2004 0320 WEDNESDAY, DECEMBER 1, 2004 Holiday Inn Rosslyn at Key Bridge 1900 North Fort Myer Drive Arlington, VA 22209 ( 703) 807 2000 DIMETHOATE: ISSUES RELATED TO HAZARD AND DOSE RESPONSE ASSESSMENT

8: 30 A. M. Introduction and Identification of Panel Members  Stephen M. Roberts, Ph. D. ( FIFRA SAP Chair)

8: 40 A. M. Administrative Procedures by Designated Federal Official  Ms. Myrta R. Christian

8: 45 A. M. Follow up from Previous Day's Discussion  Kathleen Raffaele, Ph. D. ( Health Effects Division, Office of Pesticide Programs, EPA)  Ms. Cheryl Chaffey ( Pest Management Regulatory Agency, Canada)

9: 00 A. M. Questions to the Panel Interpretation of the cholinesterase activity and pup mortality results from the dimethoate developmental neurotoxicity ( DNT) study and related studies.

Question 1.1 Please comment on the information available for dimethoate which characterizes the underlying cause( s) of the pup mortality in the dimethoate DNT study and the degree to which this information can be used to determine the impact of maternal neglect/ maternal toxicity on pup mortality. [ Section II B and Sections II C 2, 3, 5b d]

10: 00 A. M. BREAK

10: 15 A. M. Questions to the Panel ( continued)

Question 1.2 The results of the cross fostering study suggest that the pup mortality observed at lower doses in the main DNT study may not be attributable to a single dimethoate exposure. Please comment on the evidence that supports or refutes this analysis. [ Section II B 2 and II C 5 d] Page 3 of 3 Question 1.3 After considering the results of the BMD analyses for brain ChE inhibition and for pup mortality, it is proposed that brain ChE inhibition be used as the endpoint for the dimethoate risk assessment for all durations of exposure ( e. g., acute, chronic). This would also be protective for the pup mortality endpoint, because available data indicate that brain ChE inhibition occurs at doses similar to or lower than those causing increases in pup mortality. A number of factors were considered in developing this proposal:

Brain ChE inhibition occurs at doses similar to or lower than those causing ChE inhibition in other compartments;

BMD analyses results indicate a very robust dose response curve for brain ChE inhibition, with similar BMD 10 values from studies with varying modes of administration ( dietary or gavage) and durations ( short term for DNT studies and longer term for reproduction studies);

BMD analyses results indicate similar dose response curves at all ages, with no difference in BMD 10 values for different age groups following similar exposure durations;

Comparison of BMR dose levels for brain ChE inhibition and pup mortality following repeated dosing indicates that ChE inhibition occurs at doses similar to those associated with increases in pup mortality;

Evaluation of pup mortality data from the cross fostering study reveals clear increases in mortality only at the highest dose following short term exposure, indicating that increased mortality at lower doses occurs only with repeated dosing;

Comparison of the NOAEL for increased pup mortality from limited dosing with the BMD 10 for brain ChE inhibition following a single dose indicates that brain ChE inhibition occurs at doses below those causing a clear increase in pup mortality.

Please comment on the evidence that supports or refutes this proposal ( Sections IIB 4, and II C).

12: 30 P. M. ADJOURNMENT Please be advised that agenda times are approximate. For further information, please contact the Designated Federal Official for this meeting, Ms. Myrta Christian, via telephone: ( 202) 564 8450; fax: ( 202) 564 8382; or email: christian. myrta@ epa. gov


[Federal Register Volume 76, Number 234 (Tuesday, December 6, 2011)]
[Notices]
[Pages 76166-76167]
[FR Doc No: 2011-31214]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0464]

Draft Guidance for Industry and Food and Drug Administration
Staff; the Content of Investigational Device Exemption and Premarket
Approval Applications for Artificial Pancreas Device Systems;
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 the draft guidance document entitled ``Draft Guidance
for Industry and FDA Staff: The Content of Investigational Device
Exemption (IDE) and Premarket Approval (PMA) Applications for
Artificial Pancreas Device Systems.'' This draft guidance document
provides industry and the Agency staff with guidelines for developing
premarket submissions for artificial pancreas device systems, in
particular, the Control-to-Range (CTR) and Control-to-Target (CTT)
device systems. This draft guidance is not final nor is it in effect at
this time.

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 March 5, 2012.

ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Draft Guidance for Industry and FDA Staff:
The Content of Investigational Device Exemption (IDE) and Premarket
Approval (PMA) Applications for Artificial Pancreas Device Systems'' to
the Division of Small Manufacturers, International, and Consumer
Assistance, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request, or fax your request to (301)
847-8149. See the SUPPLEMENTARY INFORMATION section for information on
electronic access to the guidance.
    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. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Phil Desjardins, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5452, Silver Spring, MD 20993-0002, (301)
796-5678.

SUPPLEMENTARY INFORMATION:

I. Background

    Diabetes mellitus has reached epidemic proportions in the United
States and more recently, worldwide. The morbidity and mortality
associated with diabetes is anticipated to account for a substantial
proportion of health care expenditures. Although there are many devices
available that help patients manage the disease, FDA recognizes the
need for new and improved devices for treatment of diabetes. One of the
more advanced diabetes management systems is an artificial pancreas
device system. An artificial pancreas system is a type of autonomous
system that adjusts insulin infusion based upon the continuous glucose
monitor (CGM) via control algorithm. There are a variety of types of
artificial pancreas systems depending upon the nature of the control
algorithm, including CTR, CTT, and Low Glucose Suspend systems. On June
22, 2011 (76 FR 36542), FDA announced the availability of the draft
guidance document entitled ``Draft Guidance for Industry and Food and
Drug Administration Staff: The Content of Investigational Device
Exemption and Premarket Approval Applications for Low Glucose Suspend
Device Systems.'' In this notice, FDA is announcing a draft guidance
document with recommendations developing premarket applications for
other types of artificial pancreas systems.
    CTR and CTT systems link a continuous glucose monitor to an insulin
pump and automatically reduce or increase insulin infusion based upon
specified thresholds of measured interstitial glucose levels. These
types of systems are designed to aid in the management of diabetes.
There are significant challenges in creating an autonomous system,
which were discussed in a joint FDA and NIH (National Institutes of
Health) artificial pancreas workshop on November 10, 2010 (information
available at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm226251.htm). Currently, there is no FDA-
approved artificial pancreas device. This workshop sought feedback on
ways to overcome the obstacles toward developing an artificial
pancreas. The feedback received from this workshop and the continued
communication with investigators in this field has provided valuable
input for FDA's guidances for artificial pancreas device systems. This
guidance will outline considerations for development of clinical
studies, and recommends elements that should be included in IDE and PMA
applications, focusing on critical elements of safety and effectiveness
for approval of this device type.

II. Significance of Guidance

    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 developing
investigations of and premarket applications for Artificial Pancreas
Device systems, particularly the CTT and CTR device systems. 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 statute
and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. A search capability for all CDRH guidance
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. To receive
``Draft Guidance for Industry and FDA Staff: The Content of
Investigational Device Exemption (IDE) and Premarket Approval (PMA)
Applications for Artificial Pancreas Device Systems,'' you may either
send an email request to<EMAIL_ADDRESS>to receive an electronic
copy of the document or send a fax request to<PHONE_NUMBER> to receive
a hard copy. Please use the document number 1786 to identify the
guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to currently approved collections of
information found in FDA regulations and guidance documents. These
collection of information are subject to review by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520). The collections of information in 21 CFR 56.11
are approved under OMB control number 0910-0130; the collections of
information in 21 CFR parts 801 and 809 are approved under OMB control
number 0910-0485, the collections of information in 21 CFR part 812 are
approved under OMB control number 0910-0078, and the collections of
information in 21 CFR part 814 are approved under OMB control number
0910-0231; the collections of information in 21 CFR part 820 are
approved under OMB control number 0910-0073.

V. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed 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.

    Dated: November 28, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-31214 Filed 12-5-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 81, Number 170 (Thursday, September 1, 2016)]
[Notices]
[Pages 60356-60357]
[FR Doc No: 2016-21041]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]

Advisory Committee; Cardiovascular and Renal Drugs Advisory
Committee, Renewal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; renewal of advisory committee.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
renewal of the Cardiovascular and Renal Drugs Advisory Committee by the
Commissioner of Food and Drugs (the Commissioner). The Commissioner has
determined that it is in the public interest to renew the
Cardiovascular and Renal Drugs Advisory Committee for an additional 2
years beyond the charter expiration date. The new charter will be in
effect until August 27, 2018.

DATES: Authority for the Cardiovascular and Renal Drugs Advisory
Committee will expire on August 27, 2016, unless the Commissioner
formally determines that renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: Jennifer Shepherd, Center for Drug
Evaluation and Research, Food and

Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services pursuant to 45 CFR part 11
and by the General Services Administration, FDA is announcing the
renewal of the Cardiovascular and Renal Drugs Advisory Committee. The
committee is a discretionary Federal advisory committee established to
provide advice to the Commissioner. The Cardiovascular and Renal Drugs
Advisory Committee advises the Commissioner or designee in discharging
responsibilities as they relate to helping to ensure safe and effective
drugs for human use and, as required, any other product for which the
Food and Drug Administration has regulatory responsibility.
    The Committee reviews and evaluates available data concerning the
safety and effectiveness of marketed and investigational human drug
products for use in the treatment of cardiovascular and renal disorders
and makes appropriate recommendations to the Commissioner of Food and
Drugs.
    The Committee shall consist of a core of 11 voting members
including the Chair. Members and the Chair are selected by the
Commissioner or designee from among authorities knowledgeable in the
fields of cardiology, hypertension, arrhythmia, angina, congestive
heart failure, diuresis, and biostatistics. Members will be invited to
serve for overlapping terms of up to four years. Almost all non-Federal
members of this committee serve as Special Government Employees. The
core of voting members may include one technically qualified member,
selected by the Commissioner or designee, who is identified with
consumer interests and is recommended by either a consortium of
consumer-oriented organizations or other interested persons. In
addition to the voting members, the Committee may include one non-
voting member who is identified with industry interests.
    Further information regarding the most recent charter and other
information can be found at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/CardiovascularandRenalDrugsAdvisoryCommittee/ucm094743.htm or by
contacting the Designated Federal Officer (see FOR FURTHER INFORMATION
CONTACT). In light of the fact that no change has been made to the
committee name or description of duties, no amendment will be made to
21 CFR 14.100.
    This document is issued under the Federal Advisory Committee Act (5
U.S.C. app.). For general information related to FDA advisory
committees, please visit us at http://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: August 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-21041 Filed 8-31-16; 8:45 am]
 BILLING CODE 4164-01-P