[Federal Register Volume 78, Number 184 (Monday, September 23, 2013)]
[Notices]
[Pages 58316-58318]
[FR Doc No: 2013-22960]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1073]

Complex Issues in Developing Medical Devices for Pediatric
Patients Affected by Rare Diseases; Public Workshop; Request for
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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    The Food and Drug Administration (FDA) is announcing the following
public workshop entitled ``Complex Issues in Developing Medical Devices
for Pediatric Patients Affected by Rare Diseases.'' This public
workshop is organized by the Center for Devices and Radiological Health
(CDRH) and the Office of Orphan Products Development (OOPD) and is
being held in conjunction with the Center for Drug Evaluation and
Research's workshop entitled ``Complex Issues in Developing Drug and
Biological Products for Rare Diseases.'' The purpose of the public
workshop is to discuss issues related to the following broad topics
associated with medical devices for the diagnosis and treatment of
pediatric patients affected by rare diseases: Current approaches toward
use of medical devices for pediatric clinical practice; Humanitarian
Device Exemption (HDE) marketing pathway, including the Humanitarian
Use Device (HUD) designation process; Pediatric Specialty-Specific
Practice Areas; Clinical Trials and Registries; and Pediatric Needs
Assessment and Possible Approaches to Advancing Pediatric Medical
Device Development. FDA is seeking input into these topics from
academicians, clinical practitioners, patients and advocacy groups,
industry, and governmental agencies. The input from this public
workshop will help in developing a strategic plan to encourage and
accelerate the development of new medical devices and therapies for
pediatric patients affected by rare diseases. This is part of an
ongoing effort by FDA to address the needs of pediatric patients
affected by rare diseases.
    Date and Time: The workshop will be held on January 8, 2014, from 8
a.m. to 5 p.m. This public workshop is being held in conjunction with
FDA's public workshop entitled ``Complex Issues in Developing Drug and
Biological Products for Rare Diseases'' which will be held on January
6, 2014, from 8 a.m. to 5 p.m. and on January 7, 2014, from 8 a.m. to
4:45 p.m.
    Location: The public workshop will be held at FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(section A of Rm. 1503), Silver Spring, MD 20993-0002. Entrance for the
public workshop participants (non-FDA employees) is through Building 1
where routine security check procedures will be performed. For parking
and security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    Contact Person: Carol Krueger, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 3663, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    Registration: Registration is free and available on a first-come,
first-served basis. Persons interested in attending the Complex Issues
in Developing Medical Devices for Pediatric Patients Affected by Rare
Diseases public workshop must register online by December 6, 2013, 5
p.m. Early registration is recommended because facilities are limited
and, therefore, FDA may limit the number of participants from each
organization. If time and space permit, onsite registration on the day
of the public workshop will be provided beginning at 7:30 a.m.
    If you need special accommodations due to a disability, please
contact Susan Monahan (email<EMAIL_ADDRESS>or phone: 301-
796-5661) no later than December 27, 2013.
    To register for the public workshop, please visit FDA's Medical
Devices News & Events--Workshops & Conferences calendar at  http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm.
(Select this public workshop from the posted events list.) Please
provide complete contact information for each attendee, including name,
title, affiliation, address, email, and telephone number. Those without
Internet access should contact Carol Krueger to register (see Contact
Person). Registrants will receive confirmation after they have been
accepted. You will be notified if you are on a waiting list.
    Streaming Webcast of the Public Workshop: This public workshop will
also be Webcast. Persons interested in viewing the Webcast must
register online by December 6, 2013, 5 p.m. Early registration is
recommended because Webcast connections are limited. Organizations are
requested to

register all participants, but to view using one connection per
location. Webcast participants will be sent technical system
requirements after registration and will be sent connection access
information after January 1, 2014. If you have never attended a Connect
Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get
a quick overview of the Connect Pro program, visit http://www.adobe.com/go/connectpro_overview. (FDA has verified the Web site
addresses in this document, but FDA is not responsible for any
subsequent changes to the Web sites after this document publishes in
the Federal Register.)
    Comments: FDA is holding this public workshop in response to
section 510 of the Food and Drug Safety and Innovation Act to discuss
ways to encourage and accelerate the development of new medical devices
and therapies for pediatric rare diseases. In order to permit the
widest possible opportunity to obtain public comment, FDA is soliciting
either electronic or written comments on all aspects of the public
workshop topics. The deadline for submitting comments regarding this
public workshop is February 5, 2014.
    Regardless of attendance at the public workshop, interested persons
may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville MD 20852. It is only necessary to send one set of
comments. Identify comments with the docket number found in brackets in
the heading of this document. In addition, when responding to specific
topics as outlined in section II of this document, please identify the
topic you are addressing. Received comments may be seen in the Division
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday,
and will be posted to the docket at http://www.regulations.gov.
    Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at http://www.regulations.gov. It may
be viewed at the Division of Dockets Management (see Comments). A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to the Division of Freedom of Information (ELEM-1029),
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg.,
Rockville, MD 20857. A link to the transcripts will also be available
approximately 45 days after the public workshop on the Internet at
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list).

SUPPLEMENTARY INFORMATION:

I. Background

    The demand by health care professionals and consumers for safe and
effective medical devices for use for pediatric patients affected by
rare diseases continues to steadily increase. To meet that demand,
clinicians and organizations representing patients and physicians have
cited the widespread practice of modifying adult devices for pediatric
use. Certain adult medical devices may be inappropriate for pediatric
use due to a variety of factors, including patient size, growth, and
development, or may require design changes or special labeling for
pediatric use.\1\
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    \1\ ''Premarket Assessment of Pediatric Medical Devices.''
Issued May 14, 2004. This guidance may be found on FDA's Web site at
www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM089742.pdf.
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    OOPD was established to promote the development of products (drugs,
biologics, medical devices, or medical foods) that demonstrate promise
for the diagnosis, prevention, and/or treatment of rare diseases or
conditions. One of OOPD's functions is to designate devices as HUDs,
which allows them to be eligible for marketing approval under an HDE
application. The HDE pathway, authorized under section 520(m) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)), provides an
alternative pathway to market devices intended to treat or diagnose a
disease or condition that affects fewer than 4,000 individuals in the
United States per year. Roughly a quarter of the medical devices that
have received HDE marketing approval are available for pediatric
patients.
    In 2007, Congress passed the Pediatric Medical Device Safety and
Improvement Act (the Act). The Act addresses pediatric device needs by
allowing sponsors of pediatric HUDs to make a profit on sales of those
devices; explicitly permitting extrapolation of adult effectiveness
data to support a pediatric indication or extrapolation of pediatric
subpopulation effectiveness data to support an indication for another
pediatric subpopulation based on a similar course of the disease or
condition or a similar effect of the device; and providing grants to
pediatric device consortia that provide technical support and
assistance to pediatric device innovators.
    FDA is committed to supporting the development and availability of
safe and effective medical devices for pediatric patients affected by
rare diseases. The Agency has sponsored a number of workshops on issues
relevant to pediatric device development in recent years.

II. Topics for Discussion at the Public Workshop

    FDA seeks to address and receive comments on the following topics:

A. Current Clinical Practice

    1. The current use and practice trends of medical devices in rare
disease pediatric populations. For example, how much off-label use
occurs? How much modification and adaptation of existing adult devices
occurs?
    2. What risks or adverse outcomes have been reported in association
with off-label use of medical devices in rare disease pediatric
populations?

B. HUD/HDE

    1. Is there any confusion about the designation process for HUDs or
the application process for HDE's? Where have barriers been encountered
in the HDE marketing pathway, and how can they be mitigated? Please
provide examples of any specific issues, how frequently they occur and
suggestions to constructively address these barriers.
    2. Please comment on Institutional Review Board issues that arise
for HDEs that are indicated for pediatric rare diseases.

C. Specialty Practice Areas

    1. For specialty practices areas (e.g. cardiology, orthopedics, and
neurology) what existing medical devices appear to have the best
potential for modification for rare diseases that affect the pediatric
population? If possible, please prioritize existing medical devices in
terms of minimal change, moderate change, or significant change
required. Also state whether no medical device is currently available
to address the need.
    2. What are the best ways to foster efficient networking across
agencies, academia, professional societies, and patient groups to
address the medical device needs of pediatric patients with rare
diseases?

D. Clinical Trials

    1. What are the most challenging barriers in the process of
designing protocols for devices used to treat/diagnose rare pediatric
diseases?
    2. What are unique challenges in identifying appropriate endpoints
for

protocols for devices used to treat/diagnose rare pediatric diseases?
    3. What barriers related to statistical analyses must be addressed
in order to promote device development for rare pediatric diseases?
    4. How can new registries be developed or current registries be
leveraged to provide robust data on the safety and effectiveness of
pediatric medical devices to support premarket approval and clearance,
and/or enhance postmarket surveillance activities related to pediatric
medical devices?

E. Pediatric Needs Assessment

    1. Describe the parameters that should be used in determining
priority areas of development of devices, including both therapeutic
and diagnostic devices, in pediatric rare diseases.
    2. What is the best approach to conduct needs assessment of medical
devices required for use with pediatric rare diseases?

F. Device Related Issues for Diagnostic Devices

    1. What are medical device related issues that need to be addressed
for development of diagnostic medical devices?

G. Advancing Development

    1. What incentives could help advance the development of diagnostic
and therapeutic medical devices to treat pediatric rare diseases?
    2. How can possible or probable use in pediatric practice be
considered early in the development stages of all devices designed to
treat a rare disease or condition?
    3. What are potential private resources (e.g., registries,
industry, or patient advocacy groups) that could be tapped to advance
the development of medical devices for rare diseases in the pediatric
population?
    4. What are potential improvements or changes that can be made to
FDA guidance, regulations, or current science in order to help develop
and improve medical devices to address the needs of the pediatric
population affected by rare diseases?

    Dated: September 17, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-22960 Filed 9-20-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 77, Number 222 (Friday, November 16, 2012)]
[Notices]
[Pages 68798-68799]
[FR Doc No: 2012-27877]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-3354-EM;Docket ID FEMA-2012-0002]

New Jersey; Emergency and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of an
emergency for the State of New Jersey (FEMA-3354-EM), dated October 28,
2012, and related determinations.

DATES: Effective Date: October 28, 2012.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated October 28, 2012, the President issued an emergency declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121-5207 (the Stafford Act), as
follows:

    I have determined that the emergency conditions in certain areas
of the State of New Jersey resulting from Hurricane Sandy beginning
on October 26, 2012, and continuing, are of sufficient severity and
magnitude to warrant an emergency declaration under the Robert T.
Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C.
5121 et seq. (``the Stafford Act''). Therefore, I declare that such
an emergency exists in the State of New Jersey.
    You are authorized to provide appropriate assistance for
required emergency measures, authorized under Title V of the
Stafford Act, to save lives and to protect property and public
health and safety, and to lessen or avert the threat of a
catastrophe in the designated areas. Specifically, you are
authorized to provide assistance for emergency protective measures
(Category B), limited to direct Federal assistance, under the Public
Assistance program.
    Consistent with the requirement that Federal assistance is
supplemental, any

Federal funds provided under the Stafford Act for Public Assistance
will be limited to 75 percent of the total eligible costs. In order
to provide Federal assistance, you are hereby authorized to allocate
from funds available for these purposes such amounts as you find
necessary for Federal emergency assistance and administrative
expenses.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, Department
of Homeland Security, under Executive Order 12148, as amended,
Elizabeth Turner, of FEMA is appointed to act as the Federal
Coordinating Officer for this declared emergency.

    The following areas of the State of New Jersey have been designated
as adversely affected by this declared emergency:

    All counties in the State of New Jersey for emergency protective
measures (Category B), limited to direct federal assistance, under
the Public Assistance program.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2012-27877 Filed 11-15-12; 8:45 am]
BILLING CODE 9111-23-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, DC 20460

OFFICE OF  PREVENTION, PESTICIDES,  AND TOXIC SUBSTANCES

April 5, 2007

MEMORANDUM:

Subject:		INCIDENT REPORTS ASSOCIATED WITH OCTHILINONE

To:			K. Avivah Jacob, Chemical Review Manager,

			Regulatory Management Branch II

Antimicrobials Division (7510P)

From: 			Jonathan Chen

Risk Assessment and Science Support Branch (RASSB)

Antimicrobials Division (7510P)

Thru:			Norm Cook, Branch Chief

Risk Assessment and Science Support Branch (RASSB)

Antimicrobials Division (7510P)

DP Barcode:

Chemical Name:	2-n-Octyl-4-isothiazolin-3-one (Octhilinone or OIT)

PC Code:		099901

CAS Registry No. 	26530-20-1

INCIDENT REPORTS ASSOCIATED WITH

OCTHILINONE

(PC CODE:  099901)

April 5, 2007

U.S. Environmental Protection Agency

Office of Pesticide Programs

Antimicrobials Division

TABLE OF CONTENTS

  TOC \o "1-3" \h \z \u    HYPERLINK \l "_Toc163554932"  0.0
INTRODUCTION	  PAGEREF _Toc163554932 \h  4

  HYPERLINK \l "_Toc163554933"  1.0 	INCIDENT REPORT DATA ASSOCIATED
WITH HEALTH EFFECTS OF OCTHILINONE	  PAGEREF _Toc163554933 \h  4

  HYPERLINK \l "_Toc163554934"  1.1 	OPP’s Incident Data System (IDS)
 PAGEREF _Toc163554934 \h  5

  HYPERLINK \l "_Toc163554935"  1.2 	 Poison Control Center (1993
through 2002)	  PAGEREF _Toc163554935 \h  5

  HYPERLINK \l "_Toc163554936"  1.3 	California Data - 1982 through 2004
  PAGEREF _Toc163554936 \h  5

  HYPERLINK \l "_Toc163554937"  1.4 	National Pesticide
Telecommunications Network (NPTN)	  PAGEREF _Toc163554937 \h  5

  HYPERLINK \l "_Toc163554938"  1.5 	Incident Reports Associated with
Acute Toxic Effects of Octhilinone Published in Scientific Literature.
PAGEREF _Toc163554938 \h  6

  HYPERLINK \l "_Toc163554939"  3.0	SUMMARY AND CONCLUSION	  PAGEREF
_Toc163554939 \h  6

  HYPERLINK \l "_Toc163554940"  4.0	REFERENCE	  PAGEREF _Toc163554940 \h
 7

0.0	INTRODUCTION tc  \l 0 "10.0	INTRODUCTION"

Octhilinone (PC Code 099901) is used as an antimicrobial agent for
materials preservation, wood preservation, and water systems biocide
treatments.  Examples of the materials preserved using OIT include
carpeting, vinyl, leather, textiles, mattresses, metalworking fluids,
plastics, polymers, and coatings (e.g., stains, paints). Some of the
usages are considered high exposure scenarios, such as metal working
fluids, sap-stain prevention in wood preservation etc.  The purpose of
this chapter is to review the incidences of health effects in humans and
environment resulting from exposure to octhilinone. This reports
summarized the potential health effects of octhilinone in humans,
reported as incident reports from different sources.

1.0 	INCIDENT REPORT DATA ASSOCIATED WITH HEALTH EFFECTS OF OCTHILINONE

The following databases have been consulted for the poisoning incident
data on the active ingredient octhilinone:

OPP Incident Data System (IDS) - The Incident Data System of The Office
of Pesticide Programs (OPP) of the Environmental Protection Agency (EPA)
contains  reports of incidents from various sources, including
registrants, other federal and state health and environmental agencies
and individual consumers, submitted to OPP since 1992.  Reports
submitted to the Incident Data System represent anecdotal reports or
allegations only, unless otherwise stated.  Typically no conclusions can
be drawn implicating the pesticide as a cause of any of the reported
health effects.  Nevertheless, sometimes with enough cases and/or enough
documentation risk mitigation measures may be suggested.

Poison Control Centers - as the result of a data purchase by EPA, OPP
received Poison Control Center data covering the years 1993 through 2002
for all pesticides.  Most of the national Poison Control Centers (PCCs)
participate in a national data collection system, the Toxic Exposure
Surveillance System, which obtains data from about 65-70 centers at
hospitals and universities.  PCCs provide telephone consultation for
individuals and health care providers on suspected poisonings, involving
drugs, household products, pesticides, etc.

California Department of Pesticide Regulation - California has collected
uniform data on suspected pesticide poisonings since 1982.  Physicians
are required, by statute, to report to their local health officer all
occurrences of illness suspected of being related to exposure to
pesticides.  The majority of the incidents involve workers.  Information
on exposure (worker activity), type of illness (systemic, eye, skin,
eye/skin and respiratory), likelihood of a causal relationship, and
number of days off work and in the hospital are provided.

National Pesticide Telecommunications Network (NPTN) - NPTN is a
toll-free information service supported by OPP.  A ranking of the top
200 active ingredients for which telephone calls were received during
calendar years 1984-1991, inclusive, has been prepared.  The total
number of calls was tabulated for the categories human incidents, animal
incidents, calls for information, and others.

Published Incident Reports - Some incident reports associated with
octhilinone related human health hazard are published in the scientific
literature.

1.1 	OPP’s Incident Data System (IDS)  tc  \l 0 "21.1 	OPPs Incident
Data System (IDS)"

A total of 30 individual incident cases submitted to the EPA Office of
Pesticide Programs reported to be related to exposure to octhilinone.
After carefully review all these incidences, only one incidence is
potentially associated with octhilinone exposure.  In this incidence, a
mechanic exposed to octhilinone containing solution with water on
opening a pipe.  He did not realize he had been exposed until he felt
burning.  Burns, blistering and swelling ensued and he was hospitalized
two days after the initial incident for skin infection at the site of
exposure.

1.2 	 Poison Control Center (1993 through 2002) tc  \l 0 "21.2 	 Poison
Control Center"

No incidence were reported in the Poison Control Center database
covering the years 1993 through 2002 related to octhilinone exposure.

1.3 	California Data - 1982 through 2004

Detailed descriptions of 5 definite cases associated with octhilinone
exposure submitted to the California Pesticide Illness Surveillance
Program (1982-2004) were reviewed. All the reported cases are
occupationally related.  Table 1 presents the types of illnesses
reported by year.  All the incidences involved skin irritation type
reaction at the site of exposure.  Redness, burning of the skin,
moderate to severe erythematous and second degree burn are the reported
symptoms associated in these incidences.  There is one worker in the
reported incidences took one day off work as a result of the illness.

1.4 	National Pesticide Telecommunications Network (NPTN)

There are no incident reported in the NPTN database related octhilinone
exposure.

Table 1.  Cases Due to Octhilinone Exposure in California Reported by
Type of Illness and Year, 1982-1998

Year

Illness Type

Systemica

Eye

Skin

Respiratory

Combination

Total

1983

-

-

2

-

-

2

1991

-

-	1	-

-

1

1992

-

-

1

-

-

1

1995

-

-

1

-

-

1

Total

-

-

5

-

-

5

a Category include cases where skin, eye, or respiratory effects were
also reported.

b Category includes combined irritative effects to eye, skin, and
respiratory system.

1.5 	Incident Reports Associated with Acute Toxic Effects of Octhilinone
Published in Scientific Literature.

Several papers have been published outlining the problems associated
with the use of octhilinone.  All the incidences were related to dermal
exposure to the chemical of concern.  Contact dermatitis wase reported
as the primary concern for all these reported incidences (Young et al.,
2004; Thormann 1982).  Allergic contact dermatitis is also been
suggested in some of the incidences (Foussereau, 1982; Mathias,  et al.
1983; Oleaga et al, 1992).  In a human cumulative patch test, allergic
contact dermatitis were induced with octhilinone exposure . In the
subsequent challenging patch testing using octhilinone elicited allergy
in 6 out of 6 sensitized individuals at lower concentration.

3.0	SUMMARY AND CONCLUSION  tc  \l 0 "13.0	SUMMARY AND CONCLUSION"

There are some incident reported associated with exposure to
octhilinone. Most of involved incidences are happened in occupational
setting.  Dermal exposure is the primary exposure route for all these
reported incidence.  Most of the incidences are related to irritation
and/or allergic type reaction.  The most common symptoms reported for
cases of dermal exposure were skin irritation/burning, rash, itching,
redness and blistering.  Allergic contact dermatitis also been
reported..

4.0	REFERENCE tc  \l 0 "14.0	REFERENCE"

Andersen,  KE;  and Veien NK. 1985. Biocide Patch . Contact Dermatitis,
Vol. 12, No. 2, pages 99-103

Emmett, EA; , Ng,  SK;  Levy,  MA.; Moss, JN; and Morici,  IJ. 1989.
The irritancy and allergenicity of 2-n-octyl-4-isothiazolin-3-one (Skane
M-8), with recommendations for patch test concentration. Contact
Dermatitis. 20(1):21-6.

Foussereau, J.; Brändle I.; Boujnah-Khouadja,  A. 1984.  Allergic
contact eczema caused by isothiazolin-3-one derivatives. Derm Beruf
Umwelt. 1984; 32(6):208-211

Mathias,  CG, Andersen,  KE; and Hamann,  K. 1983.  Allergic contact
dermatitis from 2-n-octyl-4-isothiazolin-3-one, a paint mildewcide.
Contact Dermatitis. Nov; 9(6):507-9.

Oleaga,  JM;  Aguirre,  A.; Landa,  N.; Gonzalez,  M. and  Diaz-Perez,
JL 1992. Allergic contact dermatitis from Kathon 893. Contact
Dermatitis. 27(5):345-6.

Thormann,  J.  1982.  Contact dermatitis to a new fungicide,
2-n-octyl-4-isothiazolin-3-one. Contact Dermatitis.  May; 8(3):204

Young,  HS,; Ferguson,  JE., Beck MH. 2004 Contact dermatitis from
2-n-octyl-4-isothiazolin-3-one in a PhD student. Contact Dermatitis.
50(1):47-8.

Attachment 1

 PAGE  7


[Federal Register: October 17, 2007 (Volume 72, Number 200)]
[Notices]
[Page 58920-58922]
[DOCID:fr17oc07-120]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-56644; File No. SR-FINRA-2007-016]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Reflect the Closing of the NASD/BSE Trade
Reporting Facility

October 11, 2007.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on October 9, 2007, the Financial Industry Regulatory Authority, Inc.
(``FINRA'') (f/k/a the National Association of Securities Dealers, Inc.
(``NASD'')) filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared substantially by FINRA. FINRA
has submitted the proposed rule change under Section 19(b)(3)(A) of the
Act \3\ and Rule 19b-4(f)(6) thereunder,\4\ which renders the proposal
effective upon filing with the Commission.\5\ The Commission is
publishing this notice to solicit comments on the proposed rule change
from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6).
    \5\ FINRA has asked the Commission to waive the 30-day operative
delay provided in Rule 19b-4(f)(6)(iii). 17 CFR 240.19b-
4(f)(6)(iii).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    FINRA proposes to delete in their entirety the NASD Rule 4000D,
6000D, and 7000D Series and the Limited Liability Company Agreement of
The NASD/BSE Trade Reporting Facility LLC (the ``NASD/BSE TRF LLC
Agreement''), in light of the recent closing of the NASD/BSE Trade
Reporting Facility (the ``NASD/BSE TRF'').\6\
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    \6\ Effective July 30, 2007, FINRA was formed through the
consolidation of NASD and the member regulatory functions of NYSE
Regulation, Inc. Accordingly, from that date until the date it
closed on September 21, 2007, the NASD/BSE TRF was doing business as
the FINRA/BSE TRF.
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    The text of the proposed rule change is available at http://www.finra.org
, at the principal offices of FINRA, and at the

Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, FINRA included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. FINRA has prepared summaries, set forth in sections A,
B, and C below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The NASD/BSE TRF was approved by the Commission \7\ and commenced
operation in February 2007 to provide members with a mechanism for
reporting locked-in trades in NMS stocks, as defined in Rule 600(b)(47)
of Regulation NMS under the Act,\8\ effected otherwise than on an
exchange. The Boston Stock Exchange, Inc. (``BSE''), the ``Business
Member'' under the NASD/BSE TRF LLC Agreement,

determined to close the NASD/BSE TRF for business reasons. Accordingly,
as of the close of business on September 21, 2007, the NASD/BSE TRF
ceased accepting trade reports.\9\
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    \7\ See Securities Exchange Act Release No. 54931 (December 13,
2006), 71 FR 76409 (December 20, 2006) (order approving File No. SR-
NASD-2006-115).
    \8\ 17 CFR 242.600(b)(47).
    \9\ Although the NASD/BSE TRF is no longer operating, pursuant
to the termination provisions in the NASD/BSE TRF LLC Agreement, the
NASD/BSE Trade Reporting Facility LLC will continue its corporate
existence until October 30, 2007.
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    FINRA members were given prior notice of the closing and were
further notified that any members using the NASD/BSE TRF to report
trades were required to find an alternative mechanism to satisfy their
trade reporting obligations. Prior to September 21, 2007, FINRA and BSE
staff worked to ensure that FINRA members that had been reporting
trades to the NASD/BSE TRF were transitioned to another FINRA facility.
FINRA represents that, notwithstanding the closing of the NASD/BSE TRF,
FINRA is able to fulfill all of its regulatory obligations with respect
to over-the-counter trade reporting through its other facilities, i.e.,
the Alternative Display Facility, the NASD/Nasdaq Trade Reporting
Facility, the NASD/NSX Trade Reporting Facility, and the NASD/NYSE
Trade Reporting Facility.
    Accordingly, FINRA proposes to delete the NASD Rule 4000D and 6000D
Series relating to trade reporting to the NASD/BSE TRF and the NASD
Rule 7000D Series relating to fees and credits for use of the NASD/BSE
TRF. In addition, FINRA proposes to delete the NASD/BSE TRF LLC
Agreement, a copy of which is included in the Manual. The proposed rule
change will ensure that FINRA's rules accurately reflect only the FINRA
facilities that are available to members for trade reporting.\10\
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    \10\ On September 12, 2007, FINRA filed a proposed rule change,
SR-FINRA-2007-012, proposing certain changes to its trade reporting
rules, including NASD Rule 6130D. See SR-FINRA-2007-012, available
at http://www.finra.org/RulesRegulation/RuleFilings/2007RuleFilings/P036903.
 FINRA will file an amendment to SR-FINRA-2007-012 to delete

the references to the NASD/BSE TRF and the proposed changes to NASD
Rule 6130D contained in that filing.
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    FINRA has filed the proposed rule change for immediate
effectiveness and requested a waiver of the 30-day operative delay.
FINRA proposes that the proposed rule change be operative on the date
of filing.
2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with
Section 15A(b)(6) of the Act,\11\ which requires, among other things,
that FINRA rules be designed to prevent fraudulent and manipulative
acts and practices, to promote just and equitable principles of trade,
and, in general, to protect investors and the public interest. FINRA
believes that by deleting rules that apply to a FINRA facility that is
no longer in operation, the proposed rule change will prevent potential
member confusion and trade reporting errors and violations.
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    \11\ 15 U.S.C. 78o-3(b)(6).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    FINRA does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    Written comments were neither solicited nor received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    FINRA has filed the proposed rule change pursuant to Section
19(b)(3)(A) of the Act \12\ and subparagraph (f)(6) of Rule 19b-4
thereunder.\13\ Because FINRA has designated the foregoing proposed
rule change as one that: (1) Does not significantly affect the
protection of investors or the public interest; (2) does not impose any
significant burden on competition; and (3) does not become operative
for 30 days from the date of filing, or such shorter time as the
Commission may designate if consistent with the protection of investors
and the public interest, the proposed rule change has become effective
pursuant to Section 19(b)(3)(A) of the Act and Rule 19b-4(f)(6)
thereunder. As required under Rule 19b-4(f)(6)(iii), FINRA provided the
Commission with written notice of its intention to file the proposed
rule change at least five business days prior to filing the proposal
with the Commission or such shorter period as designated by the
Commission.
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    \12\ 15 U.S.C. 78s(b)(3)(A).
    \13\ 17 CFR 240.19b-4(f)(6).
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    A proposed rule change filed under Rule 19b-4(f)(6) normally does
not become operative prior to 30 days after the date of filing.
However, Rule 19b-4(f)(6)(iii) permits the Commission to designate a
shorter time if such action is consistent with the protection of
investors and the public interest. FINRA has asked the Commission to
waive the 30-day operative delay to expedite the deletion of rules that
applied to the NASD/BSE TRF, a FINRA facility that is no longer in
operation, thereby preventing potential member confusion and trade
reporting errors and violations.
    The Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public interest
because the proposal will delete rules that applied to the NASD/BSE
TRF, a FINRA facility that ceased operations on September 21, 2007.\14\
Accordingly, the Commission believes that the proposal will ensure that
FINRA's rules accurately reflect the FINRA trade reporting facilities
that are in operation currently and available to accept trade reports.
For these reasons, the Commission designates the proposal to be
operative on filing with the Commission.
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    \14\ For purposes only of waiving the 30-day operative delay,
the Commission has considered the proposed rule's impact on
efficiency, competition, and capital formation. 15 U.S.C. 78c(f).
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    At any time within 60 days of the filing of such proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-FINRA-2007-016 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, Station Place, 100 F
Street, NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-FINRA-2007-016. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/

rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room, 100 F Street,
NE., Washington, DC 20549, on official business days between the hours
of 10 a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the FINRA. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make publicly available. All
submissions should refer to File Number SR-FINRA-2007-016 and should be
submitted on or before November 7, 2007.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\15\
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    \15\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. E7-20406 Filed 10-16-07; 8:45 am]

BILLING CODE 8011-01-P