[Federal Register Volume 86, Number 84 (Tuesday, May 4, 2021)]
[Notices]
[Page 23764]
[FR Doc No: 2021-09348]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-544, OMB Control No. 3235-0604]

Proposed Collection; Comment Request

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736.

Extension:
    Form 10-D.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on this collection
of information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget for extension and approval.
    Form 10-D is a periodic report used by asset-backed issuers to file
distribution and pool performance information pursuant to Rule 13a-17
(17 CFR 240.13a-17) or Rule 15d-17 (17 CFR 240.15d-17) of the
Securities Exchange Act of 1934 (``Exchange Act'') (15 U.S.C.78a et
seq.). The form is required to be filed within 15 days after each
required distribution date on the asset-backed securities, as specified
in the governing documents for such securities. The information
provided by Form 10-D is mandatory and all information is made
available to the public upon request. Form 10-D takes approximately
39.0 hours per response to prepare and is filed by approximately 8,258
respondents. We estimate that 75% of the 39.0 hours per response (29.25
hours) is prepared by the company for a total annual reporting burden
of 241,547 hours (29.25 hours per response x 8,258 responses).
    Written comments are invited on: (a) Whether this proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information will
have practical utility; (b) the accuracy of the agency's estimate of
the burden imposed by the collection of information; (c) ways to
enhance the quality, utility, and clarity of the information collected;
and (d) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid control number.
    Please direct your written comment to David Bottom, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Cynthia
Roscoe, 100 F Street NE, Washington, DC 20549 or send an email to:
<EMAIL_ADDRESS>
    Dated: April 29, 2021.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-09348 Filed 5-3-21; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 181 (Wednesday, September 18, 2013)]
[Notices]
[Pages 57388-57390]
[FR Doc No: 2013-22718]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2012-0844; FRL-9395-2]

Product Cancellation Order for Certain Pesticide Registrations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces EPA's order for the cancellations,
voluntarily requested by the registrants, and accepted by the Agency,
of the products listed in Tables 1 and 2 of Unit II., pursuant to the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). This
cancellation order follows a May 29, 2013 Federal Register Notice of
Receipt of Requests from the registrants listed in Table 3 of Unit II.,
to voluntarily cancel these product registrations. In the May 29, 2013

notice, EPA indicated that it would issue an order implementing the
cancellations, unless the Agency received substantive comments within
the 30-day comment period that would merit its further review of these
requests, or unless the registrants withdrew their requests. The Agency
received a comment on the notice but it did not merit its further
review of the requests. Further, the registrants did not withdraw their
requests. Accordingly, EPA hereby issues in this notice a cancellation
order granting the requested cancellations. Any distribution, sale, or
use of the products subject to this cancellation order is permitted
only in accordance with the terms of this order, including any existing
stocks provisions.

DATES: The effective date of the cancellations that are the subject of
this notice are as follows: The cancellation for the manufacturing
products, listed in Table 1 of Unit II., will be effective September
30, 2015, no use of listed manufacturing products to formulate any end
use products will be permitted after December 31, 2015, and the
cancellation for the end use products listed in Table 2 of Unit II.,
will be effective December 31, 2016.

FOR FURTHER INFORMATION CONTACT: Molly Clayton, Pesticide Re-Evaluation
Division (7508P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001, telephone number:<PHONE_NUMBER>; 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, and may be of
interest to a wide range of stakeholders including environmental, human
health, and agricultural advocates; the chemical industry, pesticide
users, and members of the public interested in the sale, distribution,
or use of pesticides. Since others also may be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action.

B. How can I get copies of this document and other related information?

    The docket for this action, identified by docket identification
(ID) number EPA-HQ-OPP-2012-0844, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

II. What action is the Agency taking?

    This notice announces the cancellation, as requested by
registrants, of certain manufacturing use and end use pesticide
products registered under FIFRA section 3 or 24(c). These registrations
are listed in sequence by registration number in Tables 1 and 2 of this
unit.

            Table 1--Manufacturing Use Product Cancellations
------------------------------------------------------------------------
            Registration No.                       Product name
------------------------------------------------------------------------
1021-1060..............................  D-Trans Allethrin 90%
                                          Concentrate.
1021-1128..............................  D-Trans Intermediate 1868.
1021-1550..............................  Evercide Intermediate 2416.
1021-1575..............................  Evercide Intermediate 2941.
------------------------------------------------------------------------

                 Table 2--End Use Product Cancellations
------------------------------------------------------------------------
            Registration No.                       Product name
------------------------------------------------------------------------
1021-1594..............................  Evercide Residual Pressurized
                                          Spray 2523.
1021-1607..............................  Evercide Residual Pressurized
                                          Spray 2581.
5178-5.................................  Kilmos PF Mosquito Repellent
                                          Coils.
5178-10................................  Kilmos PF Mosquito Repellent
                                          Sticks.
8848-72................................  Black Jack DS205 Insect Killer.
9688-230...............................  Chemsico Aerosol Insecticide
                                          LD.
9688-233...............................  Chemsico Wasp & Hornet Killer
                                          DL.
9688-255...............................  Chemsico Wasp  Hornet
                                          Killer DS.
10807-436..............................  Konk Insect Killer.
13283-20...............................  Rainbow Point Three Wasp & Ant
                                          Spray.
13283-22...............................  Rainbow Flying and Crawling Bug
                                          Killer.
13283-24...............................  Rainbow Flying & Crawling Bug
                                          Killer, IV.
13283-29...............................  Multi-Bug II.
13283-36...............................  Rainbow Liquid Wasp & Ant
                                          Spray.
22950-14...............................  Cobra PF Mosquito Repellent
                                          Coils.
43917-1................................  Spira Air-O-Mat.
43917-7................................  Spira Area Mosquito Repellent.
43917-8................................  Spira Punks Mosquito Coils II.
45385-9................................  Chem-Tox Insect Spray.
46515-48...............................  House & Garden Bug Killer 4.
63376-1................................  Family Mosquito Coils.
63376-2................................  Family Mosquito Repellent
                                          Coils.
63376-5................................  Family Mosquito Repellent
                                          Sticks.
82539-2................................  Ultimate Bug Candle.
83467-1................................  Buzz Buster Mosquito Repellant
                                          Coils.
------------------------------------------------------------------------

    Table 3 of this unit includes the names and addresses of record for
all registrants of the products in Tables 1 and 2 of this unit, in
sequence by EPA company number. This number corresponds to the first
part of the EPA registration numbers of the products listed in Tables 1
and 2 of this unit.

               Table 3--Registrants of Cancelled Products
------------------------------------------------------------------------
          EPA company No.                 Company name and address
------------------------------------------------------------------------
1021..............................  McLaughlin Gormley King Co., 8810
                                     10th Ave. North, Minneapolis, MN
                                     55427.
5178..............................  Blood Protection Company (China),
                                     Ltd., Agent: Regulatory West Co.,
                                     LLC, 8203 West 20th St., Suite A,
                                     Greeley, CO 80634.
8848..............................  Safeguard Chemical Corporation,
                                     Agent: Regulatory West Co., LLC,
                                     8203 West 20th St., Suite A,
                                     Greeley, CO 80634.
9688..............................  Chemsico, P.O. Box 142642, St.
                                     Louis, MO 63114.
10807.............................  Amrep, Inc., 990 Industrial Park
                                     Dr., Marietta, GA 30062.
13283.............................  Rainbow Technology Corporation,
                                     Agent: Regulatory West Co., LLC,
                                     8203 West 20th St., Suite A,
                                     Greeley, CO 80634.

22950.............................  Coils International, Inc., Agent:
                                     Regulatory West Co., LLC, 8203 West
                                     20th St., Suite A, Greeley, CO
                                     80634.
43917.............................  Zobele Holdings, P.A., Agent:
                                     Regulatory West Co., LLC, 8203 West
                                     20th St., Suite A, Greeley, CO
                                     80634.
45385.............................  CTX-Cenol Inc., 1393 East Highland
                                     Rd., Twinsburg, OH 44087.
46515.............................  Celex, Division of United Industries
                                     Corp., P.O. Box 142642, St. Louis,
                                     MO 63114.
63376.............................  Family Products SDN BHD, Agent:
                                     Regulatory West Co., LLC, 8203 West
                                     20th St., Suite A, Greeley, CO
                                     80634.
82539.............................  Kerslig Candle Light, 5807 Church
                                     Hill Way, Medina, OH 44256.
83467.............................  Multinational Resources, Inc., 9380
                                     SW. 72 St., Suite B211, Miami, FL
                                     33173.
------------------------------------------------------------------------

III. Summary of Public Comments Received and Agency Response to
Comments

    The Agency received one comment indicating that all pesticides
should be disallowed because of their effect on the environment. This
did not merit further review of the requests.

IV. Cancellation Order

    Pursuant to FIFRA section 6(f), EPA hereby approves the requested
cancellation of the registrations identified in Tables 1 and 2 of Unit
II. Accordingly, the Agency orders that the product registrations
identified in Tables 1 and 2 of Unit II., are canceled. The effective
date of the cancellations that are the subject of this notice are as
follows: The cancellation for the manufacturing products, listed in
Table 1 of Unit II., will be effective September 30, 2015, no use of
listed manufacturing products to formulate any end use products will be
permitted after December 31, 2015, and the cancellation for the end use
products listed in Table 2 of Unit II., will be effective December 31,
2016. Any distribution, sale, or use of existing stocks of the products
identified in Tables 1 and 2 of Unit II., in a manner inconsistent with
any of the provisions for disposition of existing stocks set forth in
Unit VI., will be a violation of FIFRA.

V. What is the Agency's authority for taking this action?

    Section 6(f)(1) of FIFRA provides that a registrant of a pesticide
product may at any time request that any of its pesticide registrations
be canceled or amended to terminate one or more uses. FIFRA further
provides that, before acting on the request, EPA must publish a notice
of receipt of any such request in the Federal Register. Thereafter,
following the public comment period, the EPA Administrator may approve
such a request. The notice of receipt for this action was published for
comment in the Federal Register issue of May 29, 2013 (78 FR 32248)
(FRL-9386-4). The comment period closed on June 28, 2013.

VI. Provisions for Disposition of Existing Stocks

    Existing stocks are those stocks of registered pesticide products
which are currently in the United States and which were packaged,
labeled, and released for shipment prior to the effective date of the
cancellation action. The existing stocks provisions for the products
subject to this order are as follows.
    The registrants may continue to sell and distribute existing stocks
of manufacturing use products listed in Table 1 of Unit II., up to and
including September 30, 2015, and end use products listed in Table 2 of
Unit II., up to and including December 31, 2016. The following terms
and conditions are applicable to existing stocks:
     No sale or distribution of listed manufacturing products
by any person, other than for purposes of disposal or export, will be
permitted after September 30, 2015.
     No use of listed manufacturing products to formulate end
use products will be permitted after December 31, 2015.
     As of January 1, 2017, only persons other than registrants
will be allowed to sell, distribute, or use existing stocks of
cancelled end use products until such stocks are exhausted. Use of
existing stocks will be permitted only to the extent that the use is
consistent with the terms of the previously approved labeling
accompanying the product used.

List of Subjects

    Environmental protection, Pesticides and pests, Allethrins.

    Dated: September 12, 2013.
Richard P. Keigwin, Jr.,
Director, Pesticide Re-Evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2013-22718 Filed 9-17-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 112 (Friday, June 10, 2016)]
[Notices]
[Pages 37608-37611]
[FR Doc No: 2016-13733]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Request for Nominations for Individuals and Consumer
Organizations for Advisory Committees

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is requesting that any
consumer organizations interested in participating in the selection of
voting and/or nonvoting consumer representatives to serve on its
advisory committees or panels notify FDA in writing. FDA is also
requesting nominations for voting and/or nonvoting consumer
representatives to serve on advisory committees and/or panels for which
vacancies currently exist or are expected to occur in the near future.
Nominees recommended to serve as a voting or nonvoting consumer
representative may be self-nominated or may be nominated by a consumer
organization.
    FDA seeks to include the views of women and men, members of all
racial and ethnic groups, and individuals with and without disabilities
on its advisory committees and, therefore, encourages nominations of
appropriately qualified candidates from these groups.

DATES: Any consumer organization interested in participating in the
selection of an appropriate voting or nonvoting member to represent
consumer interests on an FDA advisory committee or panel may send a
letter or email stating that interest to FDA (see ADDRESSES) by July
11, 2016, for vacancies listed in this notice. Concurrently, nomination
materials for prospective candidates should be sent to FDA (see
ADDRESSES) by July 11, 2016. Nominations will be accepted for current
vacancies and for those that will or may occur through August 31, 2016.

ADDRESSES: All statements of interest from consumer organizations
interested in participating in the selection process and consumer
representative nominations should be submitted electronically to
<EMAIL_ADDRESS>by mail to Advisory Committee Oversight
and Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103,
Silver Spring, MD 20993-0002, or by FAX:<PHONE_NUMBER>.
    Consumer representative nominations should be submitted
electronically by logging into the FDA Advisory Committee Membership
Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm, by mail to Advisory Committee Oversight and
Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver
Spring, MD 20993-0002, or by FAX:<PHONE_NUMBER>. Additional information
about becoming a member on an FDA advisory committee can also be
obtained by visiting FDA's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT: For questions relating to
participation in the selection process: Kimberly Hamilton, Advisory
Committee Oversight and Management Staff (ACOMS), Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver
Spring, MD 20993-0002,<PHONE_NUMBER> email:
<EMAIL_ADDRESS>    For questions relating to specific advisory committees or panels,
contact the appropriate Contact Person listed in table 1 in the
SUPPLEMENTARY INFORMATION section:

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is requesting that any consumer organizations interested in
participating in the selection of voting and/or nonvoting consumer
representatives to serve on its advisory committees or panels notify
FDA in writing (see table 1 for Contact Person).

                  Table 1--Advisory Committee Contacts
------------------------------------------------------------------------
              Contact person                       Committee/panel
------------------------------------------------------------------------
Janie Kim, Center for Biologics Evaluation  Allergenic Products Advisory
 and Research, Food and Drug                 Committee.
 Administration, 10903 New Hampshire Ave.,
 Bldg. 71, Rm. 6129, Silver Spring, MD
 20993-0002, Phone:<PHONE_NUMBER>, Email:
<EMAIL_ADDRESS>

Shanika Craig, Center for Devices and       Anesthesiology and
 Radiological Health, Food and Drug          Respiratory Therapy Devices
 Administration, 10903 New Hampshire Ave.,   Panel.
 Bldg. 66, Rm. 1613, Silver Spring, MD
 20993-0002, Phone:<PHONE_NUMBER>, Email:
<EMAIL_ADDRESS>Patricio Garcia, Center for Devices and     Gastroenterology and Urology
 Radiological Health, Food and Drug          Devices Panel; General and
 Administration, 10903 New Hampshire Ave.,   Plastic Surgery Devices
 Bldg. 66, Rm. 1611, Silver Spring, MD       Panel; Neurological Devices
 20993-0002, Phone:<PHONE_NUMBER>, Email:     Panel.
<EMAIL_ADDRESS>Natasha Facey, Center for Devices and       Ophthalmic Devices Panel.
 Radiological Health, Food and Drug
 Administration, 10903 New Hampshire Ave.,
 Bldg. 32, Rm. 3354, Silver Spring, MD
 20993-0002, Phone:<PHONE_NUMBER>, Email:
<EMAIL_ADDRESS>Evella Washington, Center for Devices and   Molecular and Clinical
 Radiological Health, Food and Drug          Genetics Devices Panel.
 Administration, 10903 New Hampshire Ave.,
 Bldg. 66, Rm. 1535, Silver Spring, MD
 20993-0002, Phone:<PHONE_NUMBER>, Email:
<EMAIL_ADDRESS>Cindy Hong, Center for Drug Evaluation and  Gastrointestinal Drugs
 Research, Food and Drug Administration,     Advisory Committee.
 10903 New Hampshire Ave., Bldg. 31, Rm.
 2430, Silver Spring, MD 20993-0002,
 Phone:<PHONE_NUMBER>, Email:
<EMAIL_ADDRESS>Jennifer Shepherd, Center for Drug          Medical Imaging Advisory
 Evaluation and Research, Food and Drug      Committee; Pharmaceutical
 Administration, 10903 New Hampshire Ave.,   Science and Clinical
 Bldg. 31, Rm. 2434, Silver Spring, MD       Pharmacology Advisory
 20993-0002, Phone:<PHONE_NUMBER>, Email:     Committee.
<EMAIL_ADDRESS>------------------------------------------------------------------------

    Table 2--Committee Descriptions, Type of Consumer Representative
                        Vacancy, and Approximate
------------------------------------------------------------------------
    Committee/panel/areas of                           Approximate date
        expertise needed            Type of vacancy         needed
------------------------------------------------------------------------
Allergenic Products Advisory      1--Voting.........  August 31, 2016.
 Committee--Knowledgeable in the
 fields of allergy, immunology,
 pediatrics, internal medicine,
 biochemistry, and related
 specialties.
Anesthesiology and Respiratory    1--Non-Voting.....  Immediately.
 Therapy Devices Panel--
 Anesthesiologists, pulmonary
 medicine specialists, or other
 experts who have specialized
 interests in ventilator
 support, pharmacology,
 physiology, or the effects and
 complications of anesthesia.
Gastroenterology and Urology      1--Non-Voting.....  Immediately.
 Devices Panel Science Advisory
 Board to the National Center
 for Toxicological Research--
 Knowledgeable in the fields
 related to toxicological
 research.
General and Plastic Surgery       1--Non-Voting.....  Immediately.
 Devices Panel--Surgeons
 (general, plastic,
 reconstructive, pediatric,
 thoracic, abdominal, pelvic and
 endoscopic); dermatologists;
 experts in biomaterials,
 lasers, wound healing, and
 quality of life; and
 biostatisticians.
Neurological Devices Panel--      1--Non-Voting.....  Immediately.
 Neurosurgeons (cerebrovascular
 and pediatric), neurologists
 (stroke, pediatric, pain
 management, and movement
 disorders), interventional
 neuroradiologists,
 psychiatrists, and
 biostatisticians.
Ophthalmic Devices Panel--        1--Non-Voting.....  Immediately.
 Ophthalmologists with expertise
 in corneal-external disease,
 vitreo-retinal surgery,
 glaucoma, ocular immunology,
 ocular pathology; optometrists;
 vision scientists; and
 ophthalmic professionals with
 expertise in clinical trial
 design, quality of life
 assessment, electrophysiology,
 low vision rehabilitation, and
 biostatistics.
Molecular and Clinical Genetics   1--Non-Voting.....  Immediately.
 Devices Panel--Experts in human
 genetics and in the clinical
 management of patients with
 genetic disorders, e.g.,
 pediatricians, obstetricians,
 neonatologists. The Agency is
 also interested in considering
 candidates with training in
 inborn errors of metabolism,
 biochemical and/or molecular
 genetics, population genetics,
 epidemiology and related
 statistical training.
 Additionally, individuals with
 experience in genetic
 counseling, medical ethics as
 well as ancillary fields of
 study will be considered.
Gastrointestinal Drugs Advisory   1--Voting.........  June 30, 2016.
 Committee--Knowledgeable in the
 fields of gastroenterology,
 endocrinology, surgery,
 clinical pharmacology,
 physiology, pathology, liver
 function, motility,
 esophagitis, and statistics.
Medical Imaging Advisory          1--Voting.........  June 30, 2016.
 Committee--Knowledgeable in the
 fields of nuclear medicine,
 radiology, epidemiology,
 statistics and related
 specialties.
Pharmaceutical Science and        1--Voting.........  Immediately.
 Clinical Pharmacology Advisory
 Committee--Knowledgeable in the
 fields of pharmaceutical
 manufacturing, clinical
 pharmacology, pharmacokinetics,
 bioavailability and
 bioequivalence research, the
 design and evaluation of
 clinical trials, laboratory
 analytical techniques,
 pharmaceutical chemistry,
 physiochemistry, biochemistry,
 biostatistics and related
 biomedical and pharmacological
 specialties.
------------------------------------------------------------------------

II. Functions and General Description of the Committee Duties

A. Allergenic Products Advisory Committee

    Reviews and evaluates available data concerning the safety,
effectiveness, and adequacy of labeling of marketed and investigational
allergenic biological products or materials that are administered to
humans for the diagnosis, prevention, or treatment of allergies and
allergic disease as well as the affirmation or revocation of biological
product licenses, on the safety, effectiveness, and labeling of the
product; on clinical and laboratory studies of such products; on
amendments or revisions to regulations governing the manufacture,
testing, and licensing of allergenic biological products; and on the
quality and relevance of FDA's research programs.

B. Certain Panels of the Medical Devices Advisory Committee

    Reviews and evaluates data on the safety and effectiveness of
marketed and investigational devices and makes recommendations for
their regulation. With the exception of the Medical Devices Dispute
Resolution Panel, each panel, according to its specialty area, advises
on the classification or reclassification of devices into one of three
regulatory categories; advises on any possible risks to health
associated with the use of devices; advises on formulation of product
development protocols; reviews premarket approval applications for
medical devices; reviews guidelines and guidance documents; recommends
exemption of certain devices from the application of portions of the
Federal Food, Drug, and Cosmetic Act; advises on the necessity to ban a
device; and responds to requests from the Agency to review and make
recommendations on specific issues or problems concerning the safety
and effectiveness of devices. With the exception of the Medical Devices
Dispute Resolution Panel, each panel, according to its specialty area,
may also make appropriate recommendations to the Commissioner of Food
and Drugs on issues relating to the design of clinical studies
regarding the safety and effectiveness of marketed and investigational
devices.
    The Dental Products Panel also functions at times as a dental drug
panel. The functions of the dental drug panel are to evaluate and
recommend whether various prescription drug products should be changed
to over-the-counter status and to evaluate data and make
recommendations concerning the approval of new dental drug products for
human use.
    The Medical Devices Dispute Resolution Panel provides advice to the
Commissioner on complex or contested scientific issues between FDA and
medical device sponsors, applicants, or manufacturers relating to
specific products, marketing applications, regulatory decisions and
actions by FDA, and Agency guidance and policies. The Panel makes
recommendations on issues that are lacking resolution, are highly
complex in nature, or result from challenges to regular advisory panel
proceedings or Agency decisions or actions.

C. Gastrointestinal Drugs Advisory Committee

    Reviews and evaluates available data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of gastrointestinal diseases.

D. Medical Imaging Advisory Committee

    Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational human drug products for use in
diagnostic and therapeutic procedures using radioactive pharmaceuticals
and contrast media used in diagnostic radiology.

E. Pharmaceutical Science and Clinical Pharmacology Advisory Committee

    Provide advice on scientific and technical issues concerning the
safety and effectiveness of human generic drug products for use in the
treatment of a broad spectrum of human diseases and, as required, any
other product for which FDA has regulatory responsibility. The
committee may also review Agency sponsored intramural and extramural
biomedical research programs in support of FDA's generic drug
regulatory responsibilities.

III. Criteria for Members

    Persons nominated for membership as consumer representatives on
committees or panels should meet the following criteria: (1)
Demonstrate ties to consumer and community-based organizations, (2) be
able to analyze technical data, (3) understand research design, (4)
discuss benefits and risks, and (5) evaluate the safety and efficacy of
products under review. The consumer representative should be able to
represent the consumer perspective on issues and actions before the
advisory committee; serve as a liaison between the committee and
interested consumers, associations, coalitions, and consumer
organizations; and facilitate dialogue with the advisory committees on
scientific issues that affect consumers.

IV. Selection Procedures

    Selection of members representing consumer interests is conducted
through procedures that include the use of organizations representing
the public interest and public advocacy groups. These organizations
recommend nominees for the Agency's selection. Representatives from the
consumer health branches of Federal, State, and local governments also
may participate in the selection process. Any consumer organization
interested in participating in the selection of an appropriate voting
or nonvoting member to represent consumer interests should send a
letter stating that interest to FDA (see ADDRESSES) within 30 days of
publication of this document.
    Within the subsequent 30 days, FDA will compile a list of consumer
organizations that will participate in the selection process and will
forward to each such organization a ballot listing at least two
qualified nominees selected by the Agency based on the nominations
received, together with each nominee's current curriculum vitae or
resume. Ballots are to be filled out and returned to FDA within 30
days. The nominee receiving the highest number of votes ordinarily will
be selected to serve as the member representing consumer interests for
that particular advisory committee or panel.

V. Nomination Procedures

    Any interested person or organization may nominate one or more
qualified persons to represent consumer interests on the Agency's
advisory committees or panels. Self-nominations are also accepted.
Nominations should include a cover letter and current curriculum vitae
or resume for each nominee, including a current business and/or home
address, telephone number, and email address if available, and a list
of consumer or community-based organizations for which the candidate
can demonstrate active participation.
    Nominations should also specify the advisory committee(s) or
panel(s) for which the nominee is recommended. In addition, nominations
should include confirmation that the nominee is aware of the
nomination, unless self-nominated. FDA will ask potential candidates to
provide detailed information concerning such matters as financial
holdings, employment, and research grants and/or contracts to permit
evaluation of possible sources of conflicts of interest. Members will
be invited to serve for terms up to 4 years.
    FDA will review all nominations received within the specified
timeframes and prepare a ballot containing the names of qualified
nominees. Names not selected will remain on a list of eligible nominees
and be reviewed periodically by FDA to determine continued interest.
Upon selecting qualified nominees for the ballot, FDA will provide
those consumer organizations that are participating in the selection
process with the opportunity to vote on the listed nominees. Only
organizations vote in the selection process. Persons who nominate
themselves to serve as voting or nonvoting consumer representatives
will not participate in the selection process.
    This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

    Dated: June 3, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-13733 Filed 6-9-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 234 (Thursday, December 6, 2018)]
[Notices]
[Pages 62872-62873]
[FR Doc No: 2018-26477]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1814]

Bacterial Risk Control Strategies for Blood Collection
Establishments and Transfusion Services To Enhance the Safety and
Availability of Platelets for Transfusion; Draft Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft document entitled ``Bacterial Risk Control
Strategies for Blood Collection Establishments and Transfusion Services
to Enhance the Safety and Availability of Platelets for Transfusion;
Draft Guidance for Industry.'' The draft guidance document provides
blood collection establishments and transfusion services with
recommendations to control the risk of bacterial contamination of room
temperature stored platelets intended for transfusion. The guidance
provides recommendations for all platelet products, including platelets
manufactured by automated methods (apheresis platelets), whole blood
derived (WBD) platelets, pooled platelets (pre-storage and post-
storage) and platelets stored in additive solutions. The draft guidance
replaces the draft guidance of the same title dated March 2016.

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 February 4, 2019. Submit either electronic or written
comments on the draft guidance by February 4, 2019 to ensure that the
Agency considers your comment on this draft guidance before it begins
work on the final version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2014-D-1814 for ``Bacterial Risk Control Strategies for Blood
Collection

Establishments and Transfusion Services to Enhance the Safety and
Availability of Platelets for Transfusion; Draft Guidance for
Industry.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Office of Communication, Outreach and Development, Center for
Biologics Evaluation and Research (CBER), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist the office in
processing your requests. The draft guidance may also be obtained by
mail by calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the
SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.

FOR FURTHER INFORMATION CONTACT: Jonathan McKnight, Center for
Biologics Evaluation and Research, Food and Drug Administration, Center
for Biologics Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-
0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft document entitled
``Bacterial Risk Control Strategies for Blood Collection Establishments
and Transfusion Services to Enhance the Safety and Availability of
Platelets for Transfusion; Draft Guidance for Industry.'' The draft
guidance provides blood collection establishments and transfusion
services with recommendations to control the risk of bacterial
contamination of room temperature stored platelets intended for
transfusion. The draft guidance provides recommendations for all
platelet products, including platelets manufactured by automated
methods (apheresis platelets), WBD platelets, pooled platelets (pre-
storage and post-storage) and platelets stored in additive solutions.
Additionally, this guidance provides licensed blood establishments with
recommendations on how to report implementation of manufacturing and
labeling changes under 21 CFR 601.12.
    The draft guidance replaces the draft guidance of the same title
dated March 2016 (81 FR 13798; March 15, 2016).
    Most recently, FDA convened a Blood Products Advisory Committee
(BPAC) meeting in July 2018 to discuss bacterial contamination of
platelets and strategies to control the risk. At this meeting, BPAC
considered the scientific evidence and operational considerations of
all available strategies to control the risk of bacterial contamination
of platelets with 5-day and 7-day dating, including bacterial testing
strategies using culture-based devices, rapid bacterial detection
devices, and the implementation of pathogen reduction technology. The
data presented and BPAC's discussion at the July 2018 meeting provided
the foundation for the recommendations in this 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 current thinking of FDA on bacterial risk
control strategies for blood collection establishments and transfusion
services to enhance the safety and availability of platelets for
transfusion. It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.
This guidance is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections 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 part 601 have been approved under
OMB control number 0910-0338; the collections of information in 21 CFR
part 606 have been approved under OMB control number 0910-0116; and the
collections of information in 21 CFR part 607 have been approved under
OMB control number 0910-0052.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: November 29, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-26477 Filed 12-4-18; 8:45 am]
 BILLING CODE 4164-01-P


From: Brachtl, Megan
Sent: Thursday, July 23, 2015 12:54 PM
To: 'Szabo, Aaron'; Ling, Michael
Subject: RE: SO2 Data Requirements Rule: RLSO and Clean Version
Importance: High

Aaron  -  Attached please find the documents you requested. Please let me know if you have any questions.

Thanks,
Megan

Megan V. Brachtl, Group Leader
State and Local Programs Group
Office of Air Quality Planning and Standards
U.S. Environmental Protection Agency
(919) 541-2648
<EMAIL_ADDRESS>
From: Szabo, Aaron<EMAIL_ADDRESS>Sent: Wednesday, July 22, 2015 6:09 PM
To: Ling, Michael; Brachtl, Megan
Subject: SO2 Data Requirements Rule: RLSO and Clean Version

Mike and Megan,

When you are available, can you send me a final clean and redline-strikeout version (from the original version sent to OMB) of the SO2 Data Requirements rule?  Thanks.

Aaron L. Szabo
Policy Analyst
Office of Management and Budget
202-395-3621
<EMAIL_ADDRESS>


[Federal Register Volume 86, Number 12 (Thursday, January 21, 2021)]
[Notices]
[Page 6403]
[FR Doc No: 2021-01135]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-90917; File No. SR-NYSE-2020-95]

Self-Regulatory Organizations; New York Stock Exchange LLC,
Notice of Designation of a Longer Period for Commission Action on a
Proposed Rule Change To Make Permanent Commentaries to Rule 7.35A and
Commentaries to Rule 7.35B and Make Related Changes to Rules 7.32,
7.35C, 46B, and 47

January 13, 2021.
    On November 13, 2020, New York Stock Exchange LLC (``NYSE'' or the
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to make permanent Commentaries .01(a) and (b) and
.06 to Rule 7.35A (DMM-Facilitated Core Open and Trading Halt Auctions)
and Commentaries .01 and .03 to Rule 7.35B (DMM-Facilitated Closing
Auctions) and make related changes to Rules 7.32 (Order Entry), 7.35C
(Exchange-Facilitated Closing Auctions), 46B (Regulatory Trading
Official), and 47 (Floor Officials--Unusual Situations). The proposed
rule change was published for comment in the Federal Register on
December 1, 2020.\3\ The Commission has received no comment letters on
the proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 90495 (November 24,
2020), 85 FR 77304 (December 1, 2020) (SR-NYSE-2020-95).
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    Section 19(b)(2) of the Act \4\ provides that within 45 days of the
publication of notice of the filing of a propose rule change, or within
such longer period up to 90 days as the Commission may designate if it
finds such longer period to be appropriate and published its reasons
for so finding or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
45th day after publication of the Notice for the proposed rule change
is January 15, 2021. The Commission is extending this 45-day period.
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    \4\ 15 U.S.C. 78s(b)(2).
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    The Commission finds that it is appropriate to designate a longer
period within which to take action on the proposed rule change so that
it has sufficient time to consider the proposed rule change.
Accordingly, pursuant to Section 19(b)(2) of the Act,\5\ the Commission
designates March 1, 2021, as the date by which the Commission shall
either approve or disapprove, or institute proceedings to determine
whether to approve or disapprove, the proposed rule change (File No.
SR-NYSE-2020-95).
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    \5\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
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    \6\ 17 CFR 200.30-3(a)(31).
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J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2021-01135 Filed 1-19-21; 8:45 am]
BILLING CODE 8011-01-P


                       Supplemental MOVES Modeling Files

The seven (7) zip files contained in the "Supplemental MOVES Modeling Files," submitted as part of the Connecticut PM2.5 redesignation SIP are available electronically upon request.  Please direct all request to:

      Donald O. Cooke, Environmental Scientist
      U.S. Environmental Protection Agency
      EPA New England Regional Office
      Office of Ecosystem Protection, Air Quality Planning Unit
      5 Post Office Square - Suite 100, (Mail code OEP05-2)
      Boston, MA 02109 - 3912

      Telephone<PHONE_NUMBER>
      Fax #<PHONE_NUMBER>
      E-Mail<EMAIL_ADDRESS>

1.  MOVES_input_FF2009_and_CALEV_to_MYSQL.zip

2.   MOVES_input_FF2017_and_FF2025_to_MySQL.zip

3.  MOVES_input_NH2009_and_EarlyLEV_to_MYSQL.zip

4.  MOVES_input_NH2017_and_NH2025_to_MySQL.zip

5.  MOVES_MSAccessOutputAnalysisDB_To_MySQL.zip

6.  MOVES_FF_NH_PM_RunOutputs_to_MySQL.zip

7.  MOVES_RunSpec_BatchInfo_AndRunLog_To_C_Windows7.zip