[Federal Register Volume 80, Number 179 (Wednesday, September 16, 2015)]
[Rules and Regulations]
[Pages 55548-55550]
[FR Doc No: 2015-23296]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 62

[EPA-R07-OAR-2015-0543; FRL-9933-95-Region 7]

Approval and Promulgation of Air Quality Implementation Plans for
Designated Facilities and Pollutants; Missouri; Sewage Sludge
Incinerators

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking direct
final action to approve revisions to the state plan for designated
facilities and pollutants developed under sections 111(d) and 129 of
the Clean Air Act for the State of Missouri. This direct final action
will amend the state plan to include a new plan and associated rule
implementing emission guidelines for Sewage Sludge Incinerators
published in the Federal Register on March 21, 2011.

DATES: This direct final rule will be effective November 16, 2015,
without further notice, unless EPA receives adverse comment by October
16, 2015. If EPA receives adverse comment, we will publish a timely
withdrawal of the direct final rule in the Federal Register informing
the public that the rule will not take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R07-
OAR-2015-0543, by one of the following methods:
    1. www.regulations.gov. Follow the on-line instructions for
submitting comments.
    2. Email<EMAIL_ADDRESS>    3. Mail or Hand Delivery: Paula Higbee, Environmental Protection
Agency, Air Planning and Development Branch, 11201 Renner Boulevard,
Lenexa, Kansas 66219.
    Instructions: Direct your comments to Docket ID No. EPA-R07-OAR-
2015-0543. EPA may publish any comment received to its public docket.
Do not submit electronically any information you consider to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Multimedia submissions (audio,
video, etc.) must be accompanied by a written comment. The written
comment is considered the official comment and should include
discussion of all points you wish to make. EPA will generally not
consider comments or comment contents located outside of the primary
submission (i.e. on the web, cloud, or other file sharing system). For
additional submission methods, the full EPA public comment policy,
information about CBI or multimedia submissions, and general guidance
on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets. The www.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 email comment directly to EPA without
going through www.regulations.gov, your email address will be
automatically captured and included as part of the comment that is
placed in the public 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
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy
form. Publicly available docket materials are available either
electronically in www.regulations.gov or in hard copy at the
Environmental Protection Agency, Air Planning and Development Branch,
11201 Renner Boulevard, Lenexa, Kansas 66219. The Regional Office's
official hours of business are Monday through Friday, 8:00 a.m. to 4:30
p.m., excluding legal holidays. The interested persons wanting to
examine these documents should make an appointment with the office at
least 24 hours in advance.

FOR FURTHER INFORMATION CONTACT: Paula Higbee, Environmental Protection
Agency, Air Planning and Development Branch, 11201 Renner Boulevard,
Lenexa, Kansas 66219 at<PHONE_NUMBER> or by email at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' or
``our'' refer to EPA. This section provides additional information by
addressing the following:

I. Background
II. Analysis of State Submittal
III. What Action is EPA taking?

I. Background

    The Clean Air Act (CAA) requires that state regulatory agencies
implement the emission guidelines and compliance times using a state
plan developed under sections 111(d) and 129 of the CAA. Section 111(d)
establishes general requirements and procedures on state plan
submittals for the control of designated pollutants. Section 129
requires emission guidelines to be promulgated for all categories of
sewage sludge incineration units, including sewage sludge incineration
(SSI) units. Section 129 mandates that all plan requirements be at
least as protective and restrictive as the promulgated emission
guidelines. This includes fixed final compliance dates, fixed
compliance schedules, and Title V permitting requirements for all
affected sources. Section 129 also requires that state plans be
submitted to EPA within one year after EPA's promulgation of the

emission guidelines and compliance times.
    On March 21, 2011, the EPA established emission guidelines and
compliance times for existing SSI units. The emission guidelines and
compliance times are codified at 40 CFR 60, Subpart MMMM.
    The state is issuing a new rule, 10 CSR 10-6.191 for SSI to meet
its obligation for this Federal rule. The new rule incorporates by
reference the Federal rule. The revised state plan is being issued
concurrently with this new rulemaking.
    The state originally submitted the adopted plan and corresponding
state rule to EPA on April 29, 2013. After submission to EPA, Missouri
became aware of errors in the state plan and resubmitted a corrected
version of the plan which EPA received on September 20, 2013. EPA has
analyzed the corrected version.

II. Analysis of State Submittal

    The emission guidelines and compliance times are codified in 40 CFR
60, subpart MMMM. State plans must contain specific information and the
legal mechanisms necessary to implement the emission guidelines and
compliance times. The requirements are as follows:
     Inventory of affected SSI units, including to the best of
the state's knowledge, SSI units that have shut down and are capable of
restarting.
     Inventory of emissions from affected SSI units in
Missouri.
     Compliance schedules for all affected SSI units with a
final compliance date no later than March 21, 2016 or three (3) years
after the effective date of state plan approval, whichever is earlier.
     Emission limitations, emission standards, operator
training and qualification requirements, and operating limits for
affected SSI units that are at least as protective as the emission
guidelines contained in Subpart MMMM.
     Testing, monitoring, and inspection requirements at least
as protective as those in the emission guidelines.
     Performance testing, reporting and recordkeeping
requirements at least as protective as those in the emission
guidelines.
     Certification that the hearing on the State plan was held,
a list of witnesses and organizational affiliations, if any, appearing
at the hearing, and a brief written summary of each presentation or
written submission.
     Provision for State progress reports to EPA.
     Identification of enforceable State mechanisms that were
selected for implementing the emission guidelines of Subpart MMMM.
     Demonstration of Missouri's legal authority to carry out
the sections 111(d) and 129 State plan.
    The Missouri plan includes documentation that all of these
requirements have been met. The emission limits, testing, monitoring,
reporting and recordkeeping requirements, and other aspects of the
Federal rule have been adopted by reference. Missouri rule 10 CSR 10-
6.191 contains the applicable requirements for SSI units. The state
provided documentation that it complied with the public notice and
comment requirements of 40 CFR part 60 Subpart MMMM.

III. What action is EPA taking?

    Based on the rationale discussed above, EPA is approving Missouri's
111(d) plan for Sewage Sludge Incinerators received on September 20,
2013. We are publishing this direct final rule without a prior proposed
rule because we view this as a noncontroversial action and anticipate
no adverse comment. However, in the ``Proposed Rules'' section of this
Federal Register, we are publishing a separate document that will serve
as the proposed rule to approve the revision to the 111(d) plan. If
adverse comments are received on this direct final rule. We will not
institute a second comment period on this action. Any parties
interested in commenting must do so at this time. For further
information about commenting on this rule, see the ADDRESSES section of
this document.
    If EPA receives adverse comment, we will publish a timely
withdrawal in the Federal Register informing the public that this
direct final rule will not take effect. We will address all public
comments in any subsequent final rule based on the proposed rule.

Statutory and Executive Order Reviews

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and therefore is not
subject to review under Executive Orders 12866 and 13563 (76 FR 3821,
January 21, 2011). This action is also not subject to Executive Order
13211, ``Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001). This
action merely approves state law as meeting Federal requirements and
imposes no additional requirements beyond those imposed by state law.
Accordingly, the Administrator certifies that this rulemaking will not
have a significant economic impact on a substantial number of small
entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.).
Because this rulemaking would approve pre-existing requirements under
state law and does not impose any additional enforceable duty beyond
that required by state law, it does not contain any unfunded mandate or
significantly or uniquely affect small governments, as described in the
Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).
    The SIP is not approved to apply on any Indian reservation land or
in any other area where EPA or an Indian tribe has demonstrated that a
tribe has jurisdiction. In those areas of Indian country, the rule does
not have tribal implications and will not impose substantial direct
costs on tribal governments or preempt tribal law as specified by
Executive Order 13175 (65 FR 67249, November 9, 2000).
    This action also does not have Federalism implications because it
does not have substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132 (64 FR 43255, August
10, 1999). Thus Executive Order 13132 does not apply to this action.
This action merely approves a state rule implementing a Federal
standard, and does not alter the relationship or the distribution of
power and responsibilities established in the CAA. This rulemaking also
is not subject to Executive Order 13045, ``Protection of Children from
Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23,
1997) because it approves a state rule implementing a Federal standard.
    In reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the CAA. In this
context, in the absence of a prior existing requirement for the State
to use voluntary consensus standards (VCS), EPA has no authority to
disapprove a state submission for failure to use VCS. It would thus be
inconsistent with applicable law for EPA when it reviews a state
submission, to use VCS in place of a state submission that otherwise
satisfies the provisions of the CAA. Thus, the requirements of section
12(d) of the National Technology Transfer and Advancement Act of 1995
(15 U.S.C. 272 note) do not apply. This action does not impose an
information collection burden under the provisions of the Paperwork
Reduction Act of 1995 (44

U.S.C. 3501 et seq.). Burden is defined at 5 CFR 1320.3(b).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this proposed rule
and other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register.
    A major rule cannot take effect until 60 days after it is published
in the Federal Register. This action is not a ``major rule'' as defined
by 5 U.S.C. 804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by November 16, 2015. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this rule for the purposes of judicial review nor does
it extend the time within which a petition for judicial review may be
filed, and shall not postpone the effectiveness of such rule or action.
Parties with objections to this direct final rule are encouraged to
file a comment in response to the parallel notice of proposed
rulemaking for this action published in the proposed rules section of
today's Federal Register, rather than file an immediate petition for
judicial review of this direct final rule, so that EPA can withdraw
this direct final rule and address the comment in the final rulemaking.
This action may not be challenged later in proceedings to enforce its
requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 62

    Environmental protection, Air pollution control, Administrative
practice and procedure, Intergovernmental relations, Reporting and
recordkeeping requirements, Sewage sludge incinerators.

    Dated: September 3, 2015.
Becky Weber,
Acting Regional Administrator, Region 7.
    For the reasons stated in the preamble, EPA amends 40 CFR part 62
as set forth below:

PART 62--APPROVAL AND PROMULGATION OF STATE PLANS FOR DESIGNATED
FACILITIES AND POLLUTANTS

0
1. The authority citation for part 62 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart AA--Missouri

0
2. Add Sec.  62.6363 and an undesignated center heading to read as
follows:

Air Emissions from Sewage Sludge Incinerator Units

Sec.  62.6363  Identification of plan.

    (a) On September 20, 2013, EPA received the Missouri Department of
Natural Resources (MDNR) section 111(d)/129 plan for implementation and
enforcement of 40 CFR part 60, subpart MMMM, Emission Guidelines and
Compliance Times for Existing Sewage Sludge Incineration Units.
    (b) Identification of sources: The plan applies to existing sewage
sludge incineration (SSI) units that:
    (1) Commenced construction on or before October 14, 2010, or
    (2) Commenced a modification on or before September 21, 2011,
primarily to comply with Missouri's plan, and
    (3) Meets the definition of a SSI unit defined in MDNR's plan
    (c) The effective date of the plan for existing sewage sludge
incineration units is February 5, 2013.
    (1) A revision to Missouri's 111(d) plan to incorporate state
regulation 10 CSR 10-6.191 Sewage Sludge Incinerators was state
effective May 30, 2013. The effective date of the amended plan is
November 16, 2015.
    (2) [Reserved]

[FR Doc. 2015-23296 Filed 9-15-15; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 75, Number 234 (Tuesday, December 7, 2010)]
[Notices]
[Pages 76011-76015]
[FR Doc No: 2010-30623]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-N-0056] (formerly 2004N-0234)

Annual Guidance Agenda

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is publishing its
annual guidance document agenda. This list is being published under
FDA's good guidance practices (GGPs) regulations. It is intended to
seek public comment on possible topics for future guidance document
development or revisions of existing ones.

DATES: Submit either electronic or written comments on this list and on
any agency guidance document at any time.

ADDRESSES: Submit electronic comments 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. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: For general information regarding
FDA's GGP policy contact: Lisa Helmanis, Office of Policy, Food and
Drug Administration, 10903 New Hampshire Ave., WO32, rm. 3216, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.
    For information regarding specific topics or guidances, please see
contact persons or specific offices listed in the table in the
SUPPLEMENTARY INFORMATION section of this document.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of September 19, 2000 (65 FR 56468), FDA
issued its final rule on GGPs (21 CFR 10.115). GGPs are intended to
ensure involvement of the public in the development of guidance
documents and to enhance understanding of the availability, nature, and
legal effect of such guidance documents.
    As part of FDA's effort to ensure meaningful interaction with the
public regarding guidance documents, the Agency committed to publishing
an annual guidance document agenda of possible guidance topics or
documents for development or revision during the coming year. The
Agency also committed to soliciting public input regarding these and
additional ideas for new topics or revisions to existing guidance
documents (65 FR 56468 at 56477; 21 CFR 10.115(f)(5)).
    The Agency is neither bound by this list of possible topics nor
required to issue every guidance document on this list or precluded
from issuing guidance documents not on the list set forth in this
document.
    The following list of guidance topics or documents represents
possible new topics or revisions to existing guidance documents that
the Agency is considering. The Agency solicits comments on the topics
listed in this document and also seeks additional ideas from the
public.
    The guidance documents are organized by the issuing Center or
Office within FDA, and in some cases are further grouped within the
issuing Center or Office by topic categories.

II. Center for Biologics Evaluation and Research (CBER)

------------------------------------------------------------------------
        Title/topic of guidance                      Contact
------------------------------------------------------------------------
CATEGORY--BLOOD AND BLOOD COMPONENTS:    Office of Communication,
Changes to an Approved Application:       Outreach and Development,
 Biological Products: Human Blood and     Center for Biologics
 Blood Components Intended for            Evaluation and Research (HFM-
 Transfusion or for Further Manufacture   40), Food and Drug
Implementation of an Acceptable           Administration, 1401 Rockville
 Abbreviated Donor History                Pike, suite 200N, Rockville,
 Questionnaire and Accompanying           MD 20852-1448,<PHONE_NUMBER>.
 Materials for Use in Screening
 Frequent Donors of Blood and Blood
 Components
Implementation of Acceptable Full-
 Length and Abbreviated Donor History
 Questionnaire and Accompanying
 Materials for Use in Screening Source
 Plasma Donors
Use of Nucleic Acid Tests on Pooled and
 Individual Samples From Donors of
 Whole Blood and Blood Components
 (Including Recovered Plasma, Source
 Plasma and Source Leukocytes) to
 Adequately and Appropriately Reduce
 the Risk of Transmission of Hepatitis
 B Virus.
------------------------------------------------------------------------
CATEGORY--CELLULAR, TISSUE, AND GENE     Office of Communication,
 THERAPY:                                 Outreach and Development,
Preclinical Safety Assessment of          Center for Biologics
 Investigational Cellular, Gene           Evaluation and Research (HFM-
 Therapy, and Certain Related Products    40), Food and Drug
Characterization and Qualification of     Administration, 1401 Rockville
 Cell Banks Used in the Production of     Pike, suite 200N, Rockville,
 Cellular and Gene Therapy Products       MD 20852-1448,<PHONE_NUMBER>.
Clinical Study Design for Early Phase
 Studies of Cellular and Gene
 Therapies.
------------------------------------------------------------------------
CATEGORY--OTHER                          Office of Communication,
Early Clinical Trials With Live           Outreach and Development,
 Biotherapeutic Products: Chemistry,      Center for Biologics
 Manufacturing, and Control Information   Evaluation and Research (HFM-
Bar Code Label Requirements--Question     40), Food and Drug
 and Answer (Update for Vaccines).        Administration, 1401 Rockville
                                          Pike, suite 200N, Rockville,
                                          MD 20852-1448,<PHONE_NUMBER>.
------------------------------------------------------------------------

III. Center for Drug Evaluation and Research (CDER)

    For information on the list of topics contact: Office of Training
and Communications, Division of Drug Information, 10903 New Hampshire
Ave., WO51, rm. 2201, Silver Spring, MD 20993,<PHONE_NUMBER>, FAX: 301-
847-8714, e-mail<EMAIL_ADDRESS>
Category--Advertising

 Amendment of the Brief Summary
 Comparative Claims in Prescription Drug Promotion
 Direct to Consumer (DTC) Television Advertisements--Food and
Drug Administration Amendments Act of 2007 (FDAAA) DTC Television Pre-
Review Program
 Promotion of Prescription Drug Products Using Social Media
Tools

Category--Chemistry

 Chemistry, Manufacturing, and Controls (CMC)--Postmarketing
Plan
 CMC Postapproval Changes Reportable in an Annual Report
 Comparability Protocols for Approved Drugs: CMC Information
 Standards Recognition
 Residual Drug in Transdermal Drug Delivery Systems

Category--Clinical/Medical

 Clinical Development of Drugs for Irritable Bowel Syndrome
 Oncology Endpoints: Non-Small Cell Lung Cancer
 Qualification Process for Drug Development Tools
 Responsible Inclusion of Pregnant Women in Clinical Trials

Category--Clinical Pharmacology

 Bioanalytical Methods Validation
 Clinical Pharmacogenomics: Study Design and Premarketing
Evaluation
 Clinical Pharmacology Consideration for Therapeutics Proteins
 General Clinical Pharmacology Considerations for Pediatric
Studies for Drugs and Biological Products
 Development of Extended Released Formulations

Category--Clinical/Statistical

 Adaptive Trial Designs
 Multiple Endpoints
 Non-Inferiority Trials

Category--Combination Products

 Drug Diagnostic Co-Development
 Development of Drugs in Combination

Category--Current Good Manufacturing Practices (CGMPs)/Compliance

 Contract Manufacturing
 Control of Components
 Control of Highly Potent Compounds
 Expiration Dating of Unit-Dose Repackaged Drugs: Compliance
Policy Guide
 Importation of Active Pharmaceutical Ingredients (API) for Use
in Human Drugs
 Medical Gas, General CGMP
 Non-Penicillin Beta-Lactam Contamination
 Outsourcer Pharmacy Operations Compliance Policy Guide
 Pharmaceutical Component Quality Control
 Pharmaceutical Manufacturing Statistics
 Pre-Launch Activities Importation Request (PLAIR)
 Prevention and Control of Viral Contamination
 Validation of Air Separation Processes for Medical Gas

Category--Drug Safety Information

 Best Practices for Conducting Pharmacovigilance Studies Using
Electronic Healthcare Data
 Dear Healthcare Professional Letters
 Good Naming, Labeling, and Packaging Practices to Reduce
Medication Errors

Category--Electronic Submissions

 Electronic Submission of Summary Level Clinical Site Data for
Data Integrity Review and Inspection Planning in New Drug Application
(NDA) and Biologics License Application (BLA) Submissions
 Providing Regulatory Submissions in Electronic Format--
Analysis Datasets and Documentation

Category--Investigational New Drug Application (IND)

 Adverse Events: Collection and Reporting for Secondary
Endpoints

 Determining Whether Human Research Studies Can Be Conducted
Without an IND
 IND Safety Reporting

Category--Labeling

 Drug Names and Dosage Forms
 Pediatric Information: Incorporating into Human Prescription
Drug and Biological Products Labeling

Category--Procedural

 INDs prepared and submitted by Clinical Sponsor Investigators

IV. Center for Devices and Radiological Health (CDRH)

    FDA has established a docket for CDRH, Docket No. FDA-2007-N-0270,
for comments on any or all of the proposed fiscal year 2010 guidance
documents. FDA invites interested persons to submit comments, draft
language on the proposed topics, and/or suggestions for new or
different guidance documents. FDA believes this docket is an important
tool for receiving information from interested parties and for making
information available to the public.

Guidance Related to FDAAA or General Premarket Issues

 30-Day notices and 135-day Premarket Approval Application
(PMA)
Supplements
 Actions on 510(k) Submissions
 Annual Reports for PMAs
 Protocol Review Guidance for In Vitro Diagnostics (IVDs)
 Tracking Pediatric Device Approvals
 Premarket Notification Submissions for Medical Devices That
Include Antimicrobial Agents

Guidance on Postmarket and Compliance Issues

 Medical Device Reporting for Manufacturers
 Postmarket Surveillance Under Section 522 of the Federal Food,
Drug, and
Cosmetic Act
 Electronic Registration and Listing
 Manufacturing Site Change Supplements: Content and
Inspectional
Considerations
 Quality Systems for Laboratory Developed Tests

Device Specific Guidances

 Bacillus spp. Serological Reagents
 Clinical Performance Assessment: Considerations for Computer-
Assisted Detection Devices Applied to Radiology Images and Radiology
Device Data
 Computer-Assisted Detection Devices Applied to Radiology
Images and
Radiology Device Data--Premarket Notification (510(k)) Submissions
 Coronary Drug Eluting Stents
 Dental Mouthguards
 Helicobacter Pylori
 Herpes Simplex Virus
 Impact-Resistant Lenses
 Invasive Portable Blood Glucose Monitoring Systems
 Ovarian Adnexal Mass Surgery Referral Index
 Percutaneous Transluminal Coronary Angioplasty Catheters
 Suction Apparatus Device Intended for Negative Pressure Wound
Therapy
 Tissue Adhesive With Adjunct Wound Closure Device
 Topical Oxygen Chamber for Extremities
 Transcranial Magnetic Stimulation Systems
 Yersinia
 Zonisamide and Lamotrigine Assays

Global Harmonization or Standards Related Guidances

 Application of IEC 60601-1 Third Edition in Premarket
Applications
 Global Harmonization Task Force: Quality Management System;
Process
Validation
 Global Harmonization Task Force: Postmarket Surveillance;
National Competent Authority Report Exchange Criteria and Report Form

Crosscutting, Process, and Other Guidances

 Radio-Frequency Wireless Technology in Medical Devices
 Medical Device Appeals and Complaints: Guidance on Dispute
Resolution
 Medical Devices Containing Materials From Animal Sources
(Except IVDs)

V. Center for Food Safety and Applied Nutrition (CFSAN)

------------------------------------------------------------------------
        Title/topic of guidance                      Contact
------------------------------------------------------------------------
New Dietary Ingredient Notifications...  Constance Hardy, CFSAN (HFS-
                                          810), Food and Drug
                                          Administration, 5100 Paint
                                          Branch Pkwy., College Park, MD
                                          20740,<PHONE_NUMBER>,
<EMAIL_ADDRESS>Fish and Fishery Products Hazards and    Thomas Latt, CFSAN (HFS-325),
 Controls Guidance (Edition 4).           Food and Drug Administration,
                                          5100 Paint Branch Pkwy.,
                                          College Park, MD 20740, 301-
                                          436-1423,
<EMAIL_ADDRESS>Use of Dietary Guidance Statements.....  Blakeley Denkinger, CFSAN (HFS-
                                          830), Food and Drug
                                          Administration, 5100 Paint
                                          Branch Pkwy., College Park, MD
                                          20740,<PHONE_NUMBER>),
<EMAIL_ADDRESS>                                          .
Questions and Answers Regarding Food     Rhonda Kane, CFSAN (HFS-820),
 Allergens, Including the Food Allergen   Food and Drug Administration,
 Labeling and Consumer Protection Act     5100 Paint Branch Pkwy.,
 of 2004 (Edition 5).                     College Park, MD 20740, 301-
                                          436-1803,
<EMAIL_ADDRESS>Processing of Acidified Foods..........  Michael Mignogna, CFSAN (HFS-
                                          302), Food and Drug
                                          Administration, 5100 Paint
                                          Branch Pkwy, College Park, MD
                                          20740,<PHONE_NUMBER>,
<EMAIL_ADDRESS>Calorie Declaration....................  Vincent DeJesus, CFSAN (HFS-
                                          830), Food and Drug
                                          Administration, 5100 Paint
                                          Branch Pkwy., College Park, MD
                                          20740,<PHONE_NUMBER>,
<EMAIL_ADDRESS>Compliance Policy Guide Sec. 527.300     Monica Metz, CFSAN (HFS-316),
 Dairy Products-Microbial Contaminants    Food and Drug Administration,
 and Alkaline Phosphatase Activity        5100 Paint Branch Pkwy,
 (Compliance Policy Guide 7106.08).       College Park, MD 20740, 301-
                                          436-2041,
<EMAIL_ADDRESS>Questions and Answers Regarding the      Nancy Bufano, CFSAN (HFS-315),
 Final Rule, Prevention of Salmonella     Food and Drug Administration,
 Enteritidis in Shell Eggs During         5100 Paint Branch Pkwy.,
 Production, Storage, and                 College Park, MD 20740., 301-
 Transportation.                          436-1493,
<EMAIL_ADDRESS>Prevention of Salmonella Enteritidis in  Nancy Bufano, CFSAN (HFS-315),
 Shell Eggs During Production, Storage,   Food and Drug Administration,
 and Transportation.                      5100 Paint Branch Pkwy.,
                                          College Park, MD 20740, 301-
                                          436-1493,
<EMAIL_ADDRESS>

Positive Tests for Salmonella..........  Michael Kashtock, CFSAN (HFS-
                                          317), Food and Drug
                                          Administration, 5100 Paint
                                          Branch Pkwy., College Park, MD
                                          20740,<PHONE_NUMBER>,
<EMAIL_ADDRESS>Compliance Policy Guide Sec. 550.050     Joyce Saltzman, CFSAN (HFS-
 Canned Ackee, Frozen Ackee, and Ackee    317), Food and Drug
 Products--Adulteration With Hypoglycin   Administration, 5100 Paint
 A.                                       Branch Pkwy., College Park, MD
                                          20740,<PHONE_NUMBER>,
<EMAIL_ADDRESS>Assessing the Effects of Significant     Annette McCarthy, CFSAN (HFS-
 Manufacturing Process Changes,           205), Food and Drug
 Including Emerging Technologies, on      Administration, 5100 Paint
 the Safety and Regulatory Status of      Branch Pkwy., College Park, MD
 Food Ingredients and Food Contact        20740,<PHONE_NUMBER>,
 Substances, Including Food Ingredients<EMAIL_ADDRESS> That are Color Additives.
Questions and Answers Regarding          Felicia Billingslea, CFSAN (HFS-
 Voluntary Registration by Authorized     820), Food and Drug
 Officials of Retail Food                 Administration, 5100 Paint
 Establishments and by Vending Machine    Branch Pkwy., College Park, MD
 Operators Electing to be Subject to      20740,<PHONE_NUMBER>,
 the Menu and Vending Machine Labeling<EMAIL_ADDRESS> Requirements Established by Section      v.
 4205 of the Patient Protection and
 Affordable Care Act.
Questions and Answers Regarding the      Felicia Billingslea, CFSAN (HFS-
 Effect of Section 4205 of the Patient    820), Food and Drug
 Protection and Affordable Care Act on    Administration, 5100 Paint
 State and Local Menu and Vending         Branch Pkwy., College Park, MD
 Machine Labeling Laws.                   20740,<PHONE_NUMBER>,
<EMAIL_ADDRESS>Safety of Nanoscale Materials in         Kapal Dewan, CFSAN (HFS-100),
 Cosmetic Products.                       Food and Drug Administration,
                                          5100 Paint Branch Pkwy.,
                                          College Park, MD 20740, 301-
                                          436-1130,
<EMAIL_ADDRESS>The Safety of Imported Traditional       Michael Kashtock, CFSAN (HFS-
 Pottery Intended for Use With Food and   317), Food and Drug
 the Improper Use of the Terms ``Lead     Administration, 5100 Paint
 Free,'' and the Proper Identification    Branch Pkwy., College Park, MD
 of Ornamental and Decorative Ware.       20740,<PHONE_NUMBER>,
<EMAIL_ADDRESS>------------------------------------------------------------------------

VI. Center for Tobacco Products (CTP)

------------------------------------------------------------------------
        Title/topic of guidance                      Contact
------------------------------------------------------------------------
Enforcement Policy Concerning            Office of Regulations, Center
 Rotational Warning Plans for Smokeless   for Tobacco Products, Food and
 Tobacco Products.                        Drug Administration, 9200
                                          Corporate Blvd., Rockville, MD
                                          20850,<PHONE_NUMBER>.
Compliance With Regulations Restricting  ...............................
 the Sale and Distribution of
 Cigarettes and Smokeless Tobacco to
 Protect Children and Adolescents.
Use of ``Light,'' ``Mild,'' ``Low,'' or  ...............................
 Similar Descriptors in the Label,
 Labeling, or Advertising of Tobacco
 Products.
``Harmful and Potentially Harmful        ...............................
 Constituents'' in Tobacco Products as
 Used in Section 904(e) of the Federal
 Food, Drug, and Cosmetic Act.
Tobacco Product Retailer Training        ...............................
 Program.
Civil Money Penalties for Tobacco        ...............................
 Retailers.
------------------------------------------------------------------------

VII. Center for Veterinary Medicine (CVM)

------------------------------------------------------------------------
           Title of Guidance                         Contact
------------------------------------------------------------------------
Draft Guidance for Industry--Safe        Phares Okelo, Center for
 Animal Feeding.                          Veterinary Medicine (HFV-226),
                                          Food and Drug Administration,
                                          7519 Standish Pl., MPN-4, rm.
                                          2661, Rockville, MD 20855, 240-
                                          453-6862,
<EMAIL_ADDRESS>Draft Compliance Policy Guide--          Paul Bachman, Center for
 Glucosamine/Chondroitin Animal           Veterinary Medicine (HFV-230),
 Products.                                Food and Drug Administration,
                                          7519 Standish Pl., MPN-4, rm.
                                          143, Rockville, MD 20855, 240-
                                          276-9225,
<EMAIL_ADDRESS>Final Guidance for Industry--            Dennis Bensley, Center for
 Comparability Protocols.                 Veterinary Medicine (HFV-140),
                                          Food and Drug Administration,
                                          7500 Standish Pl., MPN-2, rm.
                                          E334, Rockville, MD 20855, 240-
                                          276-8268,
<EMAIL_ADDRESS>Draft Guidance for Industry--            Michael Popek, Center for
 Fermentation Derived Intermediates,      Veterinary Medicine (HFV-144),
 Drug Substances, and Related Drug        Food and Drug Administration,
 Products for Veterinary Medicinal Use--  7500 Standish Pl., MPN-2, rm.
 Chemistry, Manufacturing, and Controls   E335, Rockville, MD 20855, 240-
 Information.                             276-8269,
<EMAIL_ADDRESS>Final Guidance for Industry--Drug        Dennis Bensley, Center for
 Substance Chemistry, Manufacturing,      Veterinary Medicine (HFV-140),
 and Controls Information.                Food and Drug Administration,
                                          7500 Standish Pl., MPN-2, rm.
                                          E334, Rockville, MD 20855, 240-
                                          276-8268,
<EMAIL_ADDRESS>Draft Guidance for Industry--Active      Urvi Desai, Center for
 Controls in Studies to Demonstrate       Veterinary Medicine (HFV-110),
 Effectiveness of a New Animal Drug for   Food and Drug Administration,
 Use in Companion Animals.                7520 Standish Pl., MPN-1, rm.
                                          203, Rockville, MD 20855, 240-
                                          276-8297,
<EMAIL_ADDRESS>Draft Guidance for Industry--Judicious   William Flynn, Center for
 Use of Antimicrobial Drugs in Food-      Veterinary Medicine (HFV-1),
 Producing Animals.                       Food and Drug Administration,
                                          7519 Standish Pl. MPN-4, rm.
                                          173, Rockville, MD 20855, 240-
                                          276-9084,
<EMAIL_ADDRESS>

Draft Guidance for Industry--Active      Lisa Troutman, Center for
 Controls in Studies to Demonstrate the   Veterinary Medicine (HFV-116),
 Effectiveness of a New Drug for Use in   Food and Drug Administration,
 Companion Animals.                       7500 Standish Pl., MPN-2, rm.
                                          N319, Rockville, MD 20855, 240-
                                          276-8322,
<EMAIL_ADDRESS>Residual Solvents in Animal Drug         Sudesh Kamath, Center for
 Products; Questions and Answers.         Veterinary Medicine (HFV-145),
                                          Food and Drug Administration,
                                          7500 Standish Pl., MPN-2, rm.
                                          E365, Rockville, MD 20855, 240-
                                          276-8260,
<EMAIL_ADDRESS>Draft Guidance for Industry--Updating    William Flynn, Center for
 Labeling of Certain Antimicrobial New    Veterinary Medicine (HFV-1),
 Animal Drug Products for Use in the      Food and Drug Administration,
 Feed or Water of Food-Producing          7519 Standish Pl., MPN-4, rm.
 Animals.                                 173, Rockville, MD 20855, 240-
                                          276-9084,
<EMAIL_ADDRESS>Final Guidance for Industry--Bracketing  Dennis Bensley, Center for
 and Matrixing Designs for Stability      Veterinary Medicine (HFV-140),
 Testing of New Veterinary Drug           Food and Drug Administration,
 Substances and Medicinal Products,       7500 Standish Pl., MPN-2, rm.
 VICH GL-45.                              E334, Rockville, MD 20855, 240-
                                          276-8268,
<EMAIL_ADDRESS>Revised Draft Guidance for Industry--    Mai, Huynh, Center for
 Impurities: Residual Solvents In New     Veterinary Medicine, (HFV-
 Veterinary Medicinal Products, Active    142), Food and Drug
 Substances and Excipients, VICH          Administration, 7500 Standish
 GL18(R).                                 Pl., Rockville, MD 20855, 240-
                                          276-8273,
<EMAIL_ADDRESS>Draft Guidance for Industry--Evaluating  Emily R. Smith, (HFV-135),
 the Effectiveness of Anticoccidial       Center for Veterinary
 Drugs in Food-Producing Animals.         Medicine, Food and Drug
                                          Administration, 7500 Standish
                                          Pl., Rockville, MD 20855, 240-
                                          276-8344, e-mail:
<EMAIL_ADDRESS>Draft Guidance for Industry--Protocol    Angela Clarke, Center for
 Submissions for the Division of          Veterinary Medicine (HFV-105),
 Therapeutic Drugs for Non-Food Animals   Food and Drug Administration,
 the Division of Production Drugs, and    7500 Standish Pl., Rockville,
 the Division of Therapeutic Drugs for    MD 20855,<PHONE_NUMBER>; e-
 Food Animals.                            mail:
<EMAIL_ADDRESS>------------------------------------------------------------------------

VIII. Office of the Commissioner

------------------------------------------------------------------------
             Guidance title/TOPIC                      OC Contact
------------------------------------------------------------------------
 Classification of products as         John Weiner, Office of
 biological products, devices, and drugs.       Combination Products,
                                                Food and Drug
                                                Administration, 10903
                                                New Hampshire Ave,
                                                Silver Spring, MD 20993
<PHONE_NUMBER>.
 Interpretation of the term            Do.
 ``chemical action' in definition of device
 under section 201(h) of the Federal Food,
 Drug, and Cosmetic Act.
 Types of submissions for              Do.
 postapproval changes to combination products.
 Information Sheet Guidance for        Bridget Foltz, Office of
 Institutional Review Boards, Clinical          Good Clinical Practices,
 Investigators, and Sponsors--FDA Inspections   Food and Drug
 of Clinical Investigators                      Administration, 10903
Describes FDA's inspectional process when the   New Hampshire Avenue,
 agency inspects the site of an investigator    Silver Spring, MD 20993,
 who is conducting a clinical study regulated<PHONE_NUMBER>.
 by FDA.
 Draft Information Sheet Guidance for  Sara Goldkind (301-796-
 Institutional Review Boards, Clinical          8342), Marsha Melvin
 Investigators, and Sponsors--A Guide to<PHONE_NUMBER>), Office
 Informed Consent                               of Good Clinical
Describes in detail basic and additional        Practices, Food and Drug
 elements of informed consent and includes      Administration, 10903
 topics such as review of patient records,      New Hampshire Ave.,
 children as subjects, and subject              Silver Spring, MD 20993.
 participation in more than one study.
 Guidance for Institutional Review     Sara Goldkind, Office of
 Boards, Clinical Investigators, and            Good Clinical Practices,
 Sponsors--Exception From Informed Consent      Food and Drug
 Requirements for Emergency Research            Administration, 10903
This final guidance is intended to assist       New Hampshire Ave.,
 sponsors, clinical investigators, and IRBs     Silver Spring, MD 20993,
 in the development, conduct, and oversight<PHONE_NUMBER>.
 of research involving FDA-regulated products
 (e.g., drugs, biological products, devices)
 in emergency settings when an exception from
 the informed consent requirements is
 requested under 21 CFR 50.24. In particular,
 the guidance clarifies FDA's expectations
 related to planning and conducting community
 consultation and public disclosure
 activities, and the establishment of
 informed consent procedures to be used when
 feasible.
------------------------------------------------------------------------

    Dated: December 1, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-30623 Filed 12-6-10; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: December 29, 2009 (Volume 74, Number 248)]
[Notices]
[Page 68893-68894]
[DOCID:fr29de09-139]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-61226; File No. SR-CTA/CQ-2009-02]

Consolidated Tape Association; Order Approving the Thirteenth
Charges Amendment to the Second Restatement of the Consolidated Tape
Association Plan and Seventh Charges Amendment to the Restated
Consolidated Quotation Plan

December 22, 2009.

I. Introduction

    On October 19, 2009, the Consolidated Tape Association (``CTA'')
Plan and Consolidated Quotation (``CQ'') Plan participants
(``Participants'') \1\ filed with the Securities and Exchange
Commission (``SEC'' or ``Commission'') pursuant to Section 11A of the
Securities Exchange Act of 1934 (``Act''),\2\ and Rule 608
thereunder,\3\ proposals \4\ to amend the Second Restatement of the CTA
Plan and Restated CQ Plan (collectively, the ``Plans'').\5\ The
proposals would: (1) delete all program classification charges from the
schedules of Network A and Network B computer input charges; and (2)
replace the current combined Network A/Network B high speed line access
charges with separate high speed line access charges for Network A and
Network B. The proposed amendments to the Plans were published for
comment in the Federal Register on November 19, 2009.\6\ No comment
letters were received in response to the Notice. This order approves
the proposed amendments to the Plans.
---------------------------------------------------------------------------

    \1\ Each participant executed the proposed amendment. The
Participants are: BATS Exchange, Inc.; Chicago Board Options
Exchange, Inc.; Chicago Stock Exchange, Inc.; Financial Industry
Regulatory Authority, Inc.; International Securities Exchange, LLC;
NASDAQ OMX BX, Inc.; NASDAQ OMX PHLX, Inc.; The NASDAQ Stock Market
LLC; National Stock Exchange, Inc.; New York Stock Exchange LLC;
NYSE Amex LLC; and NYSE Arca, Inc.
    \2\ 15 U.S.C. 78k-1.
    \3\ 17 CFR 242.608.
    \4\ On November 6, 2009, the Consolidated Tape Association sent
a revised transmittal letter correcting the number of the proposed
amendment (``Transmittal Letter'').
    \5\ See Securities Exchange Act Release Nos. 10787 (May 10,
1974), 39 FR 17799 (declaring the CTA Plan effective); 15009 (July
28, 1978), 43 FR 34851 (August 7, 1978) (temporarily authorizing the
CQ Plan); and 16518 (January 22, 1980), 45 FR 6521 (January 28,
1980) (permanently authorizing the CQ Plan). The most recent
restatement of both Plans was in 1995. The CTA Plan, pursuant to
which markets collect and disseminate last sale price information
for non-NASDAQ listed securities, is a ``transaction reporting
plan'' under Rule 601 under the Act, 17 CFR 242.601, and a
``national market system plan'' under Rule 608 under the Act, 17 CFR
242.608. The CQ Plan, pursuant to which markets collect and
disseminate bid/ask quotation information for listed securities, is
also a ``national market system plan'' under Rule 608 under the Act,
17 CFR 242.608.
    \6\ See Securities Exchange Act Release No. 60985 (November 10,
2009), 74 FR 59999 (``Notice'').
---------------------------------------------------------------------------

II. Description of the Proposal

    The Plans currently divide the different means of using market data
into eight ``program classifications.'' The program classification fees
payable by vendors and end-users depend on the category of use the
vendor or end-user makes of the data and whether the vendor or end-user
is using Network A market data or Network B market data, or both.
Through the amendments to the Plans, the Participants proposed to
eliminate program classification charges and set separate fees for the
receipt of Network A market data and Network B market data.
    The Participants stated that over time, new technologies and new
and innovative ways to use market data have made it increasingly
difficult to fit the data uses into the existing program
classifications in a manner that is consistent and equitable for all.
Therefore, the Participants concluded that it is more equitable to
charge vendors and end-users for the method of access to the data and
the quantity of usage, rather than for the specific purposes (i.e., by
program classification) to which vendors and end-users put market data.
The elimination of program classification charges means that vendors
will no longer need to provide detailed explanations of how they use
the data or to update Exhibit A to their agreements with the
Participants each time they use data in a new way.
    Additionally, the Participants proposed to revise the access fees
by setting separate fees for the receipt of Network A market data and
Network B market data. Therefore, if a vendor or end-user wishes to
receive Network A last sale prices (or quotation information), but not
Network B last sale prices (or quotation information), the vendor or
end-user would be allowed to pay only for Network A last sale prices,
without also having to pay for Network B last sale prices and vice
versa.
    In addition to establishing separate access fees for Network A and
Network B, the Participants stated that they intend to set the new
access fees at levels that will offset the revenues that the
Participants anticipate losing as a result of eliminating the program
classification fees.

III. Discussion

    After careful review, the Commission finds that the proposed
amendments to the Plans are consistent with the Act and the rules and
regulations thereunder.\7\ Specifically, the Commission finds that the
amendments are consistent with Rule 608(b)(2) \8\ of the Act in that
they are necessary for the protection of investors, the maintenance of
fair and orderly markets, and to remove impediments to a national
market system. The Commission believes that eliminating program
classification charges and replacing them with separate fees for the
receipt of Network A and Network B market data are fair and reasonable
and provide for an equitable allocation of dues, fees, and other
charges among vendors, data recipients and other persons using CTA
Network A and Network B facilities. The Commission agrees that charging
users of data based on their method of access to the data and the
amount of data they use rather than basing charges on the way vendors
or end users use the data should simplify the rate schedule, remove
subjectivity from the billing process, simplify and reduce the costs of
data administration, and give choice to data vendors and end-users who
prefer to receive data from one network only. Further, according to the
Participants' estimates, the vast majority of vendors and end-users
would realize net monthly increases or decreases of less than
$1,000.\9\ Thus, the proposed amendment is consistent with, and would
further, one of the principal objectives for the national market system
set forth in Section 11A(a)(1)(C)(iii) \10\ of the Act--increasing the
availability of market information to broker-dealers and investors.
---------------------------------------------------------------------------

    \7\ In approving this amendment, the Commission has considered
the proposed amendment's impact on efficiency, competition, and
capital formation. 15 U.S.C. 78c(f).
    \8\ 17 CFR 242.608(b)(2).
    \9\ See the Transmittal Letter.
    \10\ 15 U.S.C. 78k-1(a)(1)(C)(iii).

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

IV. Conclusion

    It is therefore ordered, pursuant to Section 11A of the Act,\11\
and the rules thereunder, that the proposed amendments to the CTA and
CQ Plans (SR-CTA/CQ-2009-02) are approved.
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78k-1.

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

    \12\ 17 CFR 200.30-3(a)(27).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-30790 Filed 12-28-09; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 117 (Wednesday, June 17, 2020)]
[Notices]
[Pages 36580-36583]
[FR Doc No: 2020-13010]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2020-0263; FRL-10009-83]

FIFRA Scientific Advisory Panel; Notice of Public Meetings and
Request for Nominations of Ad Hoc Expert Reviewers

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: There will be a 4-day public peer review meeting of the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific
Advisory Panel (SAP) to consider and review the use of new approach
methodologies (NAMs) to derive extrapolation factors and evaluate
developmental neurotoxicity for human health risk assessment. Preceding
the public peer review meeting, there will be a public preparatory
virtual meeting, conducted via teleconference and webcast, to consider
the scope and clarity of the draft charge questions for this peer
review. In addition, EPA is requesting nominations of prospective
candidates for service as ad hoc reviewers to assist the FIFRA SAP with
this review. Any interested person or organization may nominate
qualified individuals to be considered as prospective candidates for
this review by following the instructions provided in this notice.

DATES:
    Nominations: Submit nominations of candidates to serve as ad hoc
reviewers on or before July 2, 2020.
    Preparatory Virtual Meeting: The preparatory virtual meeting will
be held on August 25, 2020, from 1:00 p.m. to approximately 4:00 p.m.
(EDT). You must register online on or before August 25, 2020, to
receive the webcast meeting link and audio teleconference information.
You must submit your written comments or request time to present oral
comments for the preparatory virtual meeting on or before noon, August
21, 2020.
    Peer Review Meeting: The 4-day public peer review meeting will be
held September 15-18, 2020, from 9:00 a.m. to approximately 5:00 p.m.
(EDT) (as needed, updated times for each day may be provided in the
meeting agenda that will be posted in the docket at http://www.regulations.gov and the FIFRA SAP website at http://www.epa.gov/SAP). To make oral comments during the peer review meeting and be
included on the meeting agenda, please register by noon on September 9,
2020. Any written comments submitted for the peer review meeting on or
before September 9, 2020, will be provided to the FIFRA SAP for their
consideration before the meeting. Comments received after September 9,
2020, and prior to the oral public comment period during the meeting
will be available to the FIFRA SAP for their consideration during the
meeting.
    Special accommodations: Requests for special accommodations should
be submitted on or before August 25, 2020, to allow EPA time to process
these requests.

ADDRESSES:
    Nominations: Submit your nominations of candidates to the
Designated Federal Official (DFO) listed under FOR FURTHER INFORMATION
CONTACT.
    Preparatory Virtual Meeting: Registration is required to
participate during the public preparatory virtual meeting. Please refer
to the FIFRA SAP website at http://www.epa.gov/sap for information on
how to register.
    Peer Review Meeting: The location of the 4-day public peer review
meeting will be announced on the FIFRA SAP website at http://
www.epa.gov/sap. You may also subscribe to the following listserv for
alerts regarding this and other SAP-related activities: https://public.govdelivery.com/accounts/USAEPAOPPT/subscriber/new?topic_id=USAEPAOPPT_101. This peer review meeting may also be
viewed via webcast. Please refer to the FIFRA SAP website at http://
www.epa.gov/sap for information on how to access the webcast.
    Special accommodations: For information on access or services for
individuals with disabilities, and to request accommodation for a
disability, please contact the DFO listed under FOR FURTHER INFORMATION
CONTACT.

    Comments: Submit requests to present oral comments to the DFO
listed under FOR FURTHER INFORMATION CONTACT.
    Submit written comments, identified by docket identification (ID)
number EPA-HQ-OPP-2020-0263, through the Federal eRulemaking Portal:
http://www.regulations.gov. Follow the online instructions for
submitting comments. Do not electronically submit any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.
    Additional information on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets. For additional instructions related to this
meeting, see SUPPLEMENTARY INFORMATION.
    Please note that due to the current COVID-19 public health
emergency the EPA Docket Center (EPA/DC) and Reading Room were closed
to public visitors on March 31, 2020. Our EPA/DC staff will continue to
provide customer service via email, phone, and webform. For further
information on EPA/DC services, docket contact information and the
current status of the EPA/DC and Reading Room, please visit https://www.epa.gov/dockets. For questions about this docket, you may also
contact the DFO listed under FOR FURTHER INFORMATION CONTACT.

FOR FURTHER INFORMATION CONTACT: Tamue Gibson, DFO, Office of Science
Coordination and Policy (7201M), Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 564-7642; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. This action may
be of interest to persons who are or may be required to conduct testing
of chemical substances under the Federal Food, Drug, and Cosmetic Act
(FFDCA) and FIFRA. Since other entities may also be interested, the
Agency has not attempted to describe all the specific entities that may
be affected by this action.

B. Where can I access information about the FIFRA SAP and this meeting?

    Information about the FIFRA SAP and this meeting is available on
the FIFRA SAP website at http://www.epa.gov/scipoly/sap and in the
docket for this meeting, identified by docket ID number EPA-HQ-OPP-
2020-0263, at http://www.regulations.gov.

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

    1. Submitting CBI. Do not submit CBI information to EPA through
regulations.gov or email. If your comments contain any information that
you consider to be CBI or otherwise protected, please contact the DFO
listed under FOR FURTHER INFORMATION CONTACT to obtain special
instructions before submitting your comments.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see Tips for Effective Comments at http://www.epa.gov/dockets/comments.html.

II. Background

A. What is the purpose of the FIFRA SAP?

    The FIFRA SAP serves as one of the primary scientific peer review
mechanisms of EPA's Office of Chemical Safety and Pollution Prevention
(OCSPP) and is structured to provide independent scientific advice,
information and recommendations to the EPA Administrator on pesticides
and pesticide-related issues as to the impact of regulatory actions on
human health and the environment. The FIFRA SAP is a Federal advisory
committee established in 1975 under FIFRA that operates in accordance
with requirements of the Federal Advisory Committee Act (5 U.S.C.
Appendix I). The FIFRA SAP is composed of a permanent panel consisting
of seven members who are appointed by the EPA Administrator from
nominees provided by the National Institutes of Health and the National
Science Foundation (NSF). The FIFRA established a Science Review Board
consisting of at least 60 scientists who are available to the FIFRA SAP
on an ad hoc basis to assist in reviews conducted by FIFRA SAP. As a
scientific peer review mechanism, the FIFRA SAP provides comments,
evaluations, and recommendations to improve the effectiveness and
quality of analyses made by Agency scientists. Members of the FIFRA SAP
are scientists who have sufficient professional qualifications,
including training and experience, to provide expert advice and
recommendation to the Agency.

B. What is the purpose of this public meeting?

    In 2007, the National Research Council (NRC)'s report on Toxicity
Testing in 21st Century: A Vision and a Strategy was published which
encouraged a new paradigm in toxicity testing that reduces the reliance
on laboratory animals while moving towards in vitro and in silico
predictive approaches that are more efficient and human relevant. EPA's
Office of Pesticide Programs (OPP) has developed a strategic vision for
implementing the 2007 NRC report that has multiple components involving
a combination of computational and predictive modeling approaches, in
vitro techniques, and limited, targeted in vivo testing.
    EPA is actively engaged in numerous activities with respect to
reducing laboratory animal use and implementing in vitro and
computational approaches. As NAMs can provide human relevant
information that may be challenging to obtain with whole animal
testing. EPA is also interested in using in vitro and computational
approaches for reducing the reliance on default assumptions for risk
assessment, including the application of 10X uncertainty factors for
inter- and intra-species extrapolation.
    In recent years, EPA began collaborative work with academia, and
industry to use organophosphate pesticides (OPs) as a case study for
the development of NAMs for purposes of using data to inform
extrapolation/uncertainty and safety factors in lieu of reliance on
default factors.
    The Agency is interested in using in vitro data to derive
extrapolation factors and evaluate developmental neurotoxicity for
human health risk assessment. Specifically, the Agency is seeking
advice and recommendation from the FIFRA SAP on scientific issues
associated with the evaluation and utility of NAMs as part of a weight
of evidence evaluation of developmental neurotoxicity potential and the
use of in vitro acetylcholinesterase inhibition data to develop
interspecies and/or intraspecies data-derived extrapolation factors for
organophosphate pesticides.

C. How can I access the FIFRA SAP documents and meeting minutes?

    EPA's background paper, the supporting materials, and draft charge/
questions provided to the FIFRA SAP will be available by late-June as
described in Unit I.B. The Agency will provide additional background
documents (e.g., the meeting agenda) as the materials become available.
In addition, the FIFRA SAP will prepare meeting minutes summarizing its
recommendations to the Agency approximately 90 days after the meeting.
The meeting minutes will also be made available as described in Unit
I.B.

III. Nominations for Ad Hoc Expert Reviewers

A. How do I nominate someone to be considered as an ad hoc expert
reviewer to assist the FIFRA SAP in this peer review?

    As part of a broader process for developing a pool of candidates
for each review, FIFRA SAP staff routinely solicits the stakeholder
community for nominations of prospective candidates for service as ad
hoc reviewers. Any interested person or organization may nominate
qualified individuals to be considered as prospective candidates for a
specific topic. Nominees should be identified by name, occupation,
position, address, email address, and telephone number. The Agency will
consider all nominations of prospective candidates for this review that
are received on or before the deadline identified in the DATES section.
Final selection of ad hoc reviewers is a discretionary function of the
Agency.

B. Who can I nominate to be considered as an ad hoc expert reviewer to
assist the FIFRA SAP in this peer review?

    Individuals nominated for this meeting should have expertise in one
or more of the following areas: (i) Data derived extrapolation factors;
(ii) Development and implementation of new approach methodologies;
(iii) Statistics; (iv) Developmental neurotoxicity; (v) In vitro to in
vivo extrapolation; and (vi) Organophosphate pesticides. Nominees
should be scientists who have sufficient professional qualifications,
including training and experience, to provide expert comments on the
scientific issues for this review.

C. How will EPA select ad hoc expert reviewers to assist the FIFRA SAP
in this peer review?

    The selection of scientists to serve on a FIFRA SAP review is based
on the function of the Panel and the expertise needed to address the
Agency's charge to the Panel. No interested scientists shall be
ineligible to serve by reason of their membership on any other advisory
committee to a Federal department or agency or their employment by a
Federal department or agency, except EPA. Other factors considered
during the selection process include availability of the potential
reviewer to fully participate in the Panel's review, absence of any
conflicts of interest or appearance of loss of impartiality,
independence with respect to the matters under review, and lack of
bias. Although financial conflicts of interest, the appearance of loss
of impartiality, lack of independence, and bias may result in
disqualification, the absence of such concerns does not assure that a
candidate will be selected to serve on a FIFRA SAP review. Numerous
qualified candidates are identified for each review; therefore,
selection decisions involve carefully weighing a number of factors,
including the candidates' areas of expertise and professional
qualifications and achieving an overall balance of different scientific
perspectives on the Panel. In order to have the collective breadth of
experience needed to address the Agency's charge for this review, the
Agency anticipates selecting approximately twelve ad hoc scientists.
    FIFRA SAP members and ad hoc reviewers are subject to the
provisions of the Standards of Ethical Conduct for Employees of the
Executive Branch at 5 CFR part 2635, conflict of interest statutes in
Title 18 of the United States Code and related regulations. In
anticipation of these requirements, prospective candidates for service
on the FIFRA SAP will be asked to submit confidential financial
information which shall fully disclose, among other financial
interests, the candidate's employment, stocks, bonds, and where
applicable, sources of research support. EPA will evaluate the
candidate's financial disclosure form to assess whether there are
financial conflicts of interest, appearance of a loss of impartiality,
or any prior involvement with the development of the documents under
consideration (including previous scientific peer review) before the
candidate is considered further for service on FIFRA SAP.
    EPA plans to make a list of candidates under consideration as
prospective ad hoc panelists for this meeting available for a 15-
calendar day public comment period in July 2020. The list of the FIFRA
SAP members and ad hoc reviewers participating at this meeting will be
available as described in Unit I.B.
    Those who are selected from the pool of prospective candidates will
be asked to attend the preparatory and peer review meetings and to
participate in the discussion of key issues and assumptions at these
meetings. In addition, they will be asked to review and to help
finalize the meeting minutes and final report.

IV. Public Participation

A. How may I participate in the public peer review meeting?

    You may participate in the public peer review meeting by following
the instructions in this unit. To ensure proper receipt of comments,
nominations or other requests by EPA, it is imperative that you
identify docket ID number EPA-HQ-OPP-2020-0263 in the subject line on
the first page of your request.
    1. Written comments. The Agency encourages written comments for the
peer review meeting be submitted using the instructions in ADDRESSES
and Unit I.B. and C, on or before the date set in the DATES section.
Comments received after this date and prior to the end of the oral
public comment period during the meeting will still be provided to the
FIFRA SAP for their consideration. Anyone submitting written comments
after this date, should contact the DFO listed under FOR FURTHER
INFORMATION CONTACT. Anyone submitting written comments during the
meeting should email the DFO prior to the meeting to arrange for
distribution of their comments to the FIFRA SAP.
    2. Oral comments. The Agency encourages each individual or group
wishing to make brief oral comments to the FIFRA SAP during the peer
review meeting to submit their request to the DFO listed under FOR
FURTHER INFORMATION CONTACT on or before the date set in the DATES
section in order to be included on the meeting agenda. Requests to
present oral comments will be accepted until the date of the peer
review meeting and, to the extent that time permits, the Chair of the
FIFRA SAP may permit the presentation of oral comments at the peer
review meeting by interested persons who have not previously requested
time.
    The request should identify the name of the individual making the
presentation, the organization (if any) the individual will represent,
and any requirements for audiovisual equipment. Oral comments before
the FIFRA SAP during the peer review meeting are limited to 5 minutes
unless arrangements have been made prior to the date set in the DATES
section. In addition, each speaker should email a copy of his/her
comments to the DFO prior to the meeting for distribution to the FIFRA
SAP.
    3. Webcast. This meeting may also be viewed via webcast. Please
refer to the FIFRA SAP website at http://www.epa.gov/sap for
information on how to access the webcast.

B. How may I participate in the preparatory virtual meeting?

    Registration for the preparatory virtual meeting is required. To
participate by listening or making a comment during this meeting,
please visit: http://www.epa.gov/sap to register. Registration online
will be confirmed by

email that will include the webcast meeting link and audio
teleconference information.
    1. Written comments. Written comments for the preparatory virtual
meeting should be submitted, using the instructions in ADDRESSES and
Unit I.B. and C, on or before the date set in the DATES section.
    2. Oral comments. Registration is required to participate in the
preparatory virtual meeting. Please visit the FIFRA SAP website at
http://www.epa.gov/sap to register online. Each individual or group
wishing to make brief oral comments to the FIFRA SAP during the
preparatory virtual meeting should submit their request when
registering online or with the DFO listed under FOR FURTHER INFORMATION
CONTACT on or before the date set in the DATES section. Oral comments
before the FIFRA SAP during the preparatory virtual meeting are limited
to approximately 5 minutes due to the time constraints of this meeting.
    3. Webcast. The preparatory meeting will be webcast only. Please
refer to the FIFRA SAP website at http://www.epa.gov/sap for
information on how to access the webcast. Registration is required.

    Authority: 5 U.S.C. App. I; 7 U.S.C. 136 et seq.; 21 U.S.C. 301
et seq.

    Dated: June 8, 2020.
Hayley Hughes,
Director, Office of Science Coordination and Policy.
[FR Doc. 2020-13010 Filed 6-16-20; 8:45 am]
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