[Federal Register Volume 88, Number 173 (Friday, September 8, 2023)]
[Notices]
[Pages 62091-62093]
[FR Doc No: 2023-19402]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0350]

Use of International Standard ISO 10993-1, ``Biological
Evaluation of Medical Devices--Part 1: Evaluation and Testing Within a
Risk Management Process''; Guidance for Industry and Food and Drug
Administration Staff; 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 final guidance entitled ``Use of International
Standard ISO 10993-1, `Biological evaluation of medical devices--Part
1: Evaluation and testing within a risk management process'.'' This
guidance was revised to incorporate updates to FDA's current thinking
regarding the type of biocompatibility information that should be
provided in a premarket submission for certain devices made from common
polymers and fabrics that are in contact with intact skin. The purpose
of this guidance is to provide further clarification and updated
information on the use of International Standard ISO 10993-1,
``Biological evaluation of medical devices--Part 1: Evaluation and
testing within a risk management process'' to support premarket
approval applications (PMAs), humanitarian device exemptions (HDEs),
investigational device exemption (IDE) applications, premarket
notifications (510(k)s), and De Novo requests.

DATES: The announcement of the guidance is published in the Federal
Register on September 8, 2023.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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-2013-D-0350 for ``Use of International Standard ISO 10993-1,
`Biological evaluation of medical devices--Part 1: Evaluation and
testing within a risk management process'.'' 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,<PHONE_NUMBER>.
     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.govinfo.gov/content/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,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled ``Use
of International Standard ISO 10993-1, `Biological evaluation of
medical devices--Part 1: Evaluation and testing within a risk
management process' '' to the Office of Policy, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002; or to the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your request.

FOR FURTHER INFORMATION CONTACT: Jennifer Goode, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1656, Silver Spring, MD 20993-0002,<PHONE_NUMBER>;
or Anne Taylor, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    On September 4, 2020, FDA issued a guidance entitled ``Use of
International Standard ISO 10993-1, `Biological evaluation of medical
devices--Part 1: Evaluation and testing within a risk management
process' '' (``2020 Biocompatibility Guidance''). The 2020
Biocompatibility Guidance was developed to assist industry with PMAs,
HDEs, IDEs, 510(k)s, and De Novo requests for medical devices that come
into direct contact or indirect contact with the human body to
determine the potential for an unacceptable adverse biological response
resulting from contact of the component materials of the device with
the body.
    On October 15, 2020, FDA issued a draft guidance entitled ``Select
Updates for Biocompatibility of Certain Devices in Contact with Intact
Skin'' (the Select Updates Guidance) which proposed updates to the 2020
Biocompatibility Guidance regarding the type of biocompatibility
information that should be provided in a premarket submission for
certain devices made from common synthetic polymers and natural fabrics
that are in contact with intact skin. A notice of availability of the
draft guidance appeared in the Federal Register of October 15, 2020 (85
FR 65410).
    FDA is issuing this guidance to incorporate content from the Select
Updates Guidance. FDA considered comments received to the Select
Updates Guidance, and we revised the guidance as appropriate in
response to the comments, including addition of materials to the list
of those included in the policy and clarification of the following:
applicability of the policy to device components, devices or components
made from multiple materials, and materials including processing
chemicals; situations where additional discussion on applicability of
the policy is recommended; and clarification on characteristics of
devices or materials to which this policy does not apply. In addition,
FDA made minor updates to the guidance to align with the current
recognized versions of consensus standards. This guidance supersedes
the 2020 Biocompatibility Guidance.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on Use of International Standard ISO 10993-1,
``Biological evaluation of medical devices--Part 1: Evaluation and
testing within a risk management process.'' 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.

II. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also
available at https://www.regulations.gov, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics. Persons unable to download an electronic copy of
``Use of International Standard ISO 10993-1, `Biological evaluation of
medical devices--Part 1: Evaluation and testing within a risk
management process' '' may send an email request to [email protected] to receive an electronic copy of the document.
Please use the document number GUI00001811 and complete title to
identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no new collection of information, it
does refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
OMB under the PRA. The collections of information in the following
table have been approved by OMB:

------------------------------------------------------------------------
                                                            OMB control
    21 CFR part or guidance               Topic                 No.
------------------------------------------------------------------------
807, subpart E.................  Premarket notification.       0910-0120
814, subparts A through E......  Premarket approval.....       0910-0231
814, subpart H.................  Humanitarian Device           0910-0332
                                  Exemption.
812............................  Investigational Device        0910-0078
                                  Exemption.
860, subpart D.................  De Novo classification        0910-0844
                                  process.
``Requests for Feedback on       Q-Submissions and Early       0910-0756
 Medical Device Submissions:      Payor Feedback Request
 The Q-Submission Program and     Programs for Medical
 Meetings with Food and Drug      Devices.
 Administration Staff''.
800, 801, 809, and 830.........  Medical Device Labeling       0910-0485
                                  Regulations; Unique
                                  Device Identification.

803............................  Medical Devices;              0910-0437
                                  Medical Device
                                  Reporting;
                                  Manufacturer
                                  reporting, importer
                                  reporting, user
                                  facility reporting,
                                  distributor reporting.
822............................  Postmarket Surveillance       0910-0449
                                  of Medical Devices.
820............................  Current Good                  0910-0073
                                  Manufacturing Practice
                                  (CGMP); Quality System
                                  (QS) Regulation.
58.............................  Good Laboratory               0910-0119
                                  Practice (GLP)
                                  Regulations for
                                  Nonclinical Laboratory
                                  Studies.
------------------------------------------------------------------------

    Dated: September 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-19402 Filed 9-7-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: July 27, 2010 (Volume 75, Number 143)]
[Notices]
[Page 43996-43997]
[DOCID:fr27jy10-110]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2010-0043]

Agency Information Collection Activities: Proposed Collection;
Comment Request, OMB No. 1660-0029; Approval and Coordination of
Requirements To Use the NETC Extracurricular for Training Activities

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice; 60-day notice and request for comments; revision of a
currently approved information collection; OMB No. 1660-0029; FEMA Form
119-17-1, Request for Housing Accommodations; FEMA Form 119-17-2,
Request for Use of NETC Facilities.

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SUMMARY: The Federal Emergency Management Agency, as part of its
continuing effort to reduce paperwork and respondent burden, invites
the general public and other Federal agencies to take this opportunity
to comment on a proposed revision of a currently approved information
collection. In accordance with the Paperwork Reduction Act of 1995,
this Notice seeks comments concerning the collection of information
required to request training space and/or housing for emergency
preparedness training conducted at the Federal Emergency Management
Agency's National Emergency Training Center.

DATES: Comments must be submitted on or before September 27, 2010.

ADDRESSES: To avoid duplicate submissions to the docket, please use
only one of the following means to submit comments:
    (1) Online. Submit comments at http://www.regulations.gov under
Docket ID FEMA-2010-0043. Follow the instructions for submitting
comments.
    (2) Mail. Submit written comments to Office of Chief Counsel,
Regulation and Policy Team, DHS/FEMA, 500 C Street, SW., Room 835,
Washington, DC 20472-3100.
    (3) Facsimile. Submit comments to<PHONE_NUMBER>.
    (4) E-mail. Submit comments to<EMAIL_ADDRESS>Include Docket
ID FEMA-2010-0043 in the subject line.
    All submissions received must include the agency name and Docket
ID. Regardless of the method used for submitting comments or material,
all submissions will be posted, without change, to the Federal
eRulemaking Portal at http://www.regulations.gov, and will include any
personal information you provide. Therefore, submitting this
information makes it public. You may wish to read the Privacy Act
notice that is available via the link in the footer of http://
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Contact Merril Sollenberger, Events
and Visitors Coordinator, FEMA,<PHONE_NUMBER> for additional
information. You may contact the Records Management Division for copies
of the proposed collection of information at facsimile number (202)
646-3347 or e-mail address: FEMA-Information-Collections-
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Robert T. Stafford Disaster Relief and
Emergency Assistance Act (Stafford Act), 42 U.S.C. 5121-5207,
authorizes the President to establish a program of disaster
preparedness that utilizes services of all appropriate agencies and
includes training and exercises. Section 611 of the Stafford Act (42
U.S.C. 5196) directs that the Federal Emergency Management Agency
(FEMA) may conduct training for the purpose of emergency preparedness.
In response, FEMA established the National Emergency Training Center
(NETC), located in Emmitsburg, Maryland. The NETC site has facilities
and housing available for those participating in emergency preparedness
training and a request for use of these areas must be made in advance
of the need for such.

Collection of Information

    Title: Approval and Coordination of Requirements to Use the NETC
Extracurricular for Training Activities.
    Type of Information Collection: Revision of a currently approved
information collection.
    OMB Number: 1660-0029.
    Form Titles and Numbers: FEMA Form 119-17-1, Request for Housing
Accommodations; FEMA Form 119-17-2, Request for Use of NETC Facilities.
    Abstract: FEMA established the National Emergency Training Center
(NETC), located in Emmitsburg, Maryland to offer training for the
purpose of emergency preparedness. The NETC site has facilities and
housing available for those participating in emergency preparedness.
When training space and/or housing is required for those attending the
training, a request for use of these areas must be made in advance and
this collection provides the mechanism for such requests to be made.
    Affected Public: Not-for-profit institutions; Federal Government;
State,

Local or Tribal Government; individuals or households; and business or
other for-profit.
    Estimated Total Annual Burden Hours: 12 Hours.

                                                                           Estimated Annualized Burden Hours and Costs
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                      Avg. burden    Total annual                    Total annual
              Type of respondent                     Form name/ Form number          Number of     responses per   Total number    per response     burden  (in     Avg. hourly     respondent
                                                                                respondents     respondent     of responses     (in hours)        hours)         wage rate         cost
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 Individuals or households; Business or other   Request for Housing                           60               1              60  .1 (6 minutes)               6          $29.26         $175.56
 for-profit; Not-for-profit institutions;        Accommodations/FEMA Form 119-17-
 Farms; State, local or Tribal Government.       1.
Individuals or households; Business or other     Request for Use of NETC                      60               1              60  .1 (6 minutes)               6           29.26          175.56
 for-profit; Not-for-profit institutions;        Facilities/FEMA Form 119-17-2.
 Farms; State, local or Tribal Government.
                                                                                ----------------                ----------------                ----------------                ---------------
    Total.....................................  ................................              60  ..............             120  ..............              12  ..............          351.12
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

    Estimated Cost: There is no annual capital, start-up, operations or
maintenance cost associated with this collection.

Comments

    Comments may be submitted as indicated in the ADDRESSES caption
above. Comments are solicited to (a) evaluate whether the proposed data
collection is necessary for the proper performance of the agency,
including whether the information shall have practical utility; (b)
evaluate the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (c) enhance the quality, utility, and
clarity of the information to be collected; and (d) minimize the burden
of the collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses.

    Dated: July 16, 2010.
Tammi Hines,
Acting Director, Records Management Division, Mission Support Bureau,
Federal Emergency Management Agency, Department of Homeland Security.
[FR Doc. 2010-18326 Filed 7-26-10; 8:45 am]
BILLING CODE 9111-45-P


"King, Heidi R."<EMAIL_ADDRESS> 02/13/2008 04:29 PM

To

Ron Evans/RTP/USEPA/US@EPA

cc

Janet Cakir/RTP/USEPA/US@EPA

Subject

RE: Request for meeting to brief you, Rob, and Interagency group on the Ozone Final RIA results

Why don't we wait until you guys are ready, then we'll schedule -- at

this point there is some time on Tuesday

h

-----Original Message-----

From: King, Heidi R.

Sent: Wednesday, February 13, 2008 1:28 PM

To<EMAIL_ADDRESS> Cc<EMAIL_ADDRESS> Subject: RE: Request for meeting to brief you, Rob, and Interagency

group on the Ozone Final RIA results

Before 1:30 would work for Art, Rob and myself ...

-----Original Message-----

From<EMAIL_ADDRESS><EMAIL_ADDRESS> Sent: Wednesday, February 13, 2008 1:23 PM

To: King, Heidi R.

Cc<EMAIL_ADDRESS> Subject: RE: Request for meeting to brief you, Rob, and Interagency

group on the Ozone Final RIA results

We are trying to get thru this with internal EPA group @ 3:30, absent

the alternative baseline piece.   I am talking to Nathalie about the

alternative baseline @ 3:00.   I would like to have those 2 calls under

my belt before we commit to briefing you.   I was comfortable in doing

back to back on the benefits because there were few new items.

However, the cost portion, especially the extrapolated portion, is new

to this analysis.   I expect more internal questions and suggestions

which may change our briefing cost package before it gets to you.

Maybe we should target next Tuesday since Monday is a holiday.  Do you

have time on that day?

             "King, Heidi R."

             <Heidi_R._King@o

             mb.eop.gov>                                             To

                                      Janet Cakir/RTP/USEPA/US@EPA

             02/13/2008 01:00                                        cc

             PM                       Ron Evans/RTP/USEPA/US@EPA

                                                                Subject

                                      RE: Request for meeting to brief

                                      you, Rob, and Interagency group

                                      on the Ozone Final RIA results

Tomorrow morning at 11am?

h

-----Original Message-----

From<EMAIL_ADDRESS><EMAIL_ADDRESS> Sent: Wednesday, February 13, 2008 12:50 PM

To: King, Heidi R.

Cc<EMAIL_ADDRESS> Subject: RE: Request for meeting to brief you, Rob, and Interagency

group on the Ozone Final RIA results

Heidi,

    Looking forward to when we all get to stop juggling on March 12.

When are your next earliest available time slots for the following

meetings?

EPA/OMB - Extrapolated Costs - 1.5 hours EPA/OMB - Baseline Issue - 1.5

hours EPA/OMB/Interagency Group - Results of O3 RIA cost analysis

-Janet

_______________________________________

Janet F. Cakir, Ph.D.

Environmental Protection Specialist

Air Benefits Cost Group

109 TW Alexander Dr., (C439-02)

Research Triangle Park, NC 27711

Tel:<PHONE_NUMBER>

Fax:<PHONE_NUMBER>

email<EMAIL_ADDRESS>              "King, Heidi R."

             <Heidi_R._King@o

             mb.eop.gov>                                             To

                                      Janet Cakir/RTP/USEPA/US@EPA

             02/08/2008 03:12                                        cc

             PM

                                                                Subject

                                      RE: Request for meeting to brief

                                      you, Rob, and Interagency group

                                      on the Ozone Final RIA results

Sorry about that janet - juggling rules like a crazy woman here

Thank heavens for weekends; have a good one!

h

-----Original Message-----

From<EMAIL_ADDRESS><EMAIL_ADDRESS> Sent: Friday, February 08, 2008 3:11 PM

To: King, Heidi R.

Subject: RE: Request for meeting to brief you, Rob, and Interagency

group on the Ozone Final RIA results

Thanks, I'll look and see when people here are available.

Thanks,

Janet

_______________________________________

Janet F. Cakir, Ph.D.

Environmental Protection Specialist

Air Benefits Cost Group

109 TW Alexander Dr., (C439-02)

Research Triangle Park, NC 27711

Tel:<PHONE_NUMBER>

Fax:<PHONE_NUMBER>

email<EMAIL_ADDRESS>              "King, Heidi R."

             <Heidi_R._King@o

             mb.eop.gov>                                             To

                                      "King, Heidi R."

             02/08/2008 02:40<EMAIL_ADDRESS>              PM                       Janet Cakir/RTP/USEPA/US@EPA

                                                                     cc

                                      Ron Evans/RTP/USEPA/US@EPA,

                                      Barbara Miles/RTP/USEPA/US@EPA,

                                      Margaret

                                      Morrison/RTP/USEPA/US@EPA

                                                                Subject

                                      RE: Request for meeting to brief

                                      you, Rob, and Interagency group

                                      on the Ozone Final RIA results

Janet,

Regrets, we took this timeslot for the interagency review of Public

Comments on the Pb NAAQS ANPRM, the rationale being that we needed to

support any interagency discussion before the Administrator's option

selection

Let's try for another timeslot for the RIA discussion with the

interagency group - unless we can get time to do Pb comments on Tues or

Wed

Thanks; apologies, so many meetings, so little time --

heidi

-----Original Message-----

From: King, Heidi R.

Sent: Friday, February 08, 2008 2:36 PM

To<EMAIL_ADDRESS> Cc<EMAIL_ADDRESS><EMAIL_ADDRESS> <EMAIL_ADDRESS> Subject: RE: Request for meeting to brief you, Rob, and Interagency

group on the Ozone Final RIA results

Janet, this is not yet on Lydia's calendar -- I'm scheduling other Lydia

meetings and we wanted to make sure this is confirmed before we schedule

around it

We are confirmed for this interagency discussion on Thurs at 10am?

Thanks,

heidi

-----Original Message-----

From<EMAIL_ADDRESS><EMAIL_ADDRESS> Sent: Thursday, February 07, 2008 12:58 PM

To: King, Heidi R.

Cc<EMAIL_ADDRESS> Subject: RE: Request for meeting to brief you, Rob, and Interagency

group on the Ozone Final RIA results

We can do 10 - 11:30.  I'll get it on everyone's calendar.

Thanks,

Janet

_______________________________________

Janet F. Cakir, Ph.D.

Environmental Protection Specialist

Air Benefits Cost Group

109 TW Alexander Dr., (C439-02)

Research Triangle Park, NC 27711

Tel:<PHONE_NUMBER>

Fax:<PHONE_NUMBER>

email<EMAIL_ADDRESS>              "King, Heidi R."

             <Heidi_R._King@o

             mb.eop.gov>                                             To

                                      Janet Cakir/RTP/USEPA/US@EPA

             02/07/2008 10:40                                        cc

             AM

                                                                Subject

                                      RE: Request for meeting to brief

                                      you, Rob, and Interagency group

                                      on the Ozone Final RIA results

That's fine ... 10-11:30 might be easier on some flex-time colleagues,

if that's possible

-----Original Message-----

From<EMAIL_ADDRESS><EMAIL_ADDRESS> Sent: Thursday, February 07, 2008 10:32 AM

To: King, Heidi R.

Subject: RE: Request for meeting to brief you, Rob, and Interagency

group on the Ozone Final RIA results

What about 9:30 - 11:00 Thursday Feb 14 morning?

-Janet

  _______________________________________

Janet F. Cakir, Ph.D.

Environmental Protection Specialist

Air Benefits Cost Group

109 TW Alexander Dr., (C439-02)

Research Triangle Park, NC 27711

Tel:<PHONE_NUMBER>

Fax:<PHONE_NUMBER>

email<EMAIL_ADDRESS>              "King, Heidi R."

             <Heidi_R._King@o

             mb.eop.gov>                                             To

                                      Janet Cakir/RTP/USEPA/US@EPA

             02/07/2008 10:23                                        cc

             AM

                                                                Subject

                                      RE: Request for meeting to brief

                                      you, Rob, and Interagency group

                                      on the Ozone Final RIA results

Hi Janet,

The interagency group is schedule for a Lead Risk Assessment meeting

during that time slot.  We could do the morning, or we could do Friday

... Would either of those work for your team?

h

-----Original Message-----

From<EMAIL_ADDRESS><EMAIL_ADDRESS> Sent: Thursday, February 07, 2008 10:12 AM

To: King, Heidi R.

Cc<EMAIL_ADDRESS> Subject: Fw: Request for meeting to brief you, Rob, and Interagency

group on the Ozone Final RIA results

Heidi,

     Since we're going to be focusing on the baseline issue and

extrapolated costs with just OMB on Wednesday the 13th, we would like to

go ahead and schedule for Thursday afternoon (Feb 14) some time to brief

you and the interagency group on the cost and benefits of our primary

analysis.  We are available from 3:00 - 4:30 on Thursday the 14th.

Would that work for you?

-Janet

_______________________________________

Janet F. Cakir, Ph.D.

Environmental Protection Specialist

Air Benefits Cost Group

109 TW Alexander Dr., (C439-02)

Research Triangle Park, NC 27711

Tel:<PHONE_NUMBER>

Fax:<PHONE_NUMBER>

email<EMAIL_ADDRESS> ----- Forwarded by Janet Cakir/RTP/USEPA/US on 02/07/2008 10:06 AM -----

             "King, Heidi R."

             <Heidi_R._King@o

             mb.eop.gov>                                             To

                                      Janet Cakir/RTP/USEPA/US@EPA

             02/05/2008 05:20                                        cc

             PM                       Ron Evans/RTP/USEPA/US@EPA

                                                                Subject

                                      RE: Request for meeting to brief

                                      you, Rob, and Interagency group

                                      on the Ozone Final RIA results

Janet, I probably don't understand what you propose.  Perhaps we should

get on the phone.

Until we resolve baseline, how could there be anything to share with the

interagency group?  This is a pretty significant parameter to continuing

with the analysis.

I'm a bit worried that it appears to our leadership that we haven't made

much progress since the conversation on this issue started last

Nov/December.

I suggest we resolve our discussions around baseline as quickly as

possible and make sure the extrapolation estimates make sense before we

invite the interagency group (rather than spend time reviewing partially

complete work).

Thoughts?

-----Original Message-----

From<EMAIL_ADDRESS><EMAIL_ADDRESS> Sent: Tuesday, February 05, 2008 5:09 PM

To: King, Heidi R.

Cc<EMAIL_ADDRESS> Subject: RE: Request for meeting to brief you, Rob, and Interagency

group on the Ozone Final RIA results

We will be covering the extrapolated costs as a part of this briefing.

The baseline issue will have to wait until after this briefing.  We are

working on your table and would like for our next baseline discussion to

include more details about how we would conduct the alternate baseline

sensitivity analysis and the kind of impact it might have on the cost

and benefit estimates in the RIA.  For wednesday, the cost/benefit

results briefing will focus only on our primary analysis.  We can follow

that up shortly thereafter (no later than a week) with the baseline

sensitivity analysis.  Will that plan work?

-Janet

_______________________________________

Janet F. Cakir, Ph.D.

Environmental Protection Specialist

Air Benefits Cost Group

109 TW Alexander Dr., (C439-02)

Research Triangle Park, NC 27711

Tel:<PHONE_NUMBER>

Fax:<PHONE_NUMBER>

email<EMAIL_ADDRESS>              "King, Heidi R."

             <Heidi_R._King@o

             mb.eop.gov>                                             To

                                      Janet Cakir/RTP/USEPA/US@EPA

             02/05/2008 04:09                                        cc

             PM                       Ron Evans/RTP/USEPA/US@EPA

                                                                Subject

                                      RE: Request for meeting to brief

                                      you, Rob, and Interagency group

                                      on the Ozone Final RIA results

It would be great to set this on calendar.

I believe it will be preceded by conversations on baseline and also

extrapolated costs -- Ron suggested extrap cost estimates would be

available 2/11.

Let me know what works - thank you Janet,

heidi

-----Original Message-----

From<EMAIL_ADDRESS><EMAIL_ADDRESS> Sent: Tuesday, February 05, 2008 3:35 PM

To: King, Heidi R.

Cc<EMAIL_ADDRESS> Subject: Request for meeting to brief you, Rob, and Interagency group on

the Ozone Final RIA results

Heidi,

      Ron and I would like to get together with you, Rob, and the

interagency group to brief you on the results of the Ozone Final RIA.

We can meet any time Wednesday 13th, afternoon from 1 - 4.  Is there a

2-hour time slot in there that will work for you?  I'll be getting back

to you on the baseline issue shortly and I don't anticipate that it will

be a part of this particular meeting.

Thanks,

-Janet

_______________________________________

Janet F. Cakir, Ph.D.

Environmental Protection Specialist

Air Benefits Cost Group

109 TW Alexander Dr., (C439-02)

Research Triangle Park, NC 27711

Tel:<PHONE_NUMBER>

Fax:<PHONE_NUMBER>

email<EMAIL_ADDRESS>


[Federal Register: July 29, 2010 (Volume 75, Number 145)]
[Notices]
[Page 44826-44828]
[DOCID:fr29jy10-89]

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SECURITIES AND EXCHANGE COMMISSION

Release No. 34-62553; File No. SR-BX-2010-050]

 Self-Regulatory Organizations; NASDAQ OMX BX, Inc.; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change To Expand
the $1 Strike Program on the Boston Options Exchange Facility

July 22, 2010.
    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 July 19, 2010, NASDAQ OMX BX, Inc. (the ``Exchange'') filed
with the Securities and Exchange Commission (``SEC'' or ``Commission'')
the proposed rule change as described in Items I and II below, which
Items have been prepared by the Exchange. The Exchange filed the
proposed rule change pursuant to 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. The Commission is publishing this
notice to solicit comments on the proposed rule 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).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Chapter IV, Section 6 (Series of
Options Contracts Open for Trading) of the Rules of the Boston Options
Exchange Group, LLC (``BOX'') to expand the Exchange's $1 Strike Price
Program (the ``$1 Strike Program'' or ``Program'') to allow the
Exchange to select 150 individual stocks on which options may be listed
at $1 strike price intervals. The text of the proposed rule change is
available from the principal office of the Exchange, at the
Commission's Public Reference Room, on the Commission's Web site at
http://www.sec.gov, and also on the Exchange's Internet Web site at
http://nasdaqomxbx.cchwallstreet.com/NASDAQOMXBX/Filings/.

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

    In its filing with the Commission, the self-regulatory organization
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. The self-regulatory organization
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 purpose of this proposed rule change is to expand the $1 Strike
Program (the ``Program'').\5\ The $1 Strike Program currently allows
BOX to select a total of 55 individual stocks on which option series
may be listed at $1 strike price intervals. In order to be eligible for
selection into the Program, the underlying stock must close below $50
in its primary market on the previous trading day. If selected for the
Program, BOX may list strike prices at $1 intervals from $1 to $50, but
no $1 strike price may be listed that is greater than $5 from the
underlying stock's closing price in its primary market on the previous
day. BOX may also list $1 strikes on any other option class designated
by another securities exchange that employs a similar Program under
their respective rules. BOX may not list long-term option series
(``LEAPS'') \6\ at $1 strike price intervals for any class selected for
the Program, except as provided in Supplementary Material .02(c) to
Chapter IV, Section 6 of the BOX Rules.\7\ BOX is also restricted from
listing series with $1 intervals within $0.50 of an existing strike
price in the same series, except that strike prices of $2, $3, and $4
shall be permitted within $0.50 of an existing strike price for classes
also selected to participate in the $0.50 Strike Program.\8\
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    \5\ The Commission approved the $1 Strike Price Program as a
pilot in February 2004. See Securities Exchange Act Release No.
49292 (Feb. 20, 2004), 69 FR 8993 (Feb. 26, 2004) (SR-BSE-2004-01).
The Program was subsequently extended. See Securities Exchange Act
Release No. 49806 (June 4, 2004), 69 FR 32640 (June 10, 2004) (SR-
BSE-2004-22) (extending the Program until June 5, 2005); Securities
Exchange Act Release No. 51778 (June 2, 2005), 70 FR 33562 (June 8,
2005) (SR-BSE-2005-18) (extending the Program until June 5, 2006);
Securities Exchange Act Release No. 53855 (May 24, 2006), 71 FR
30973 (May 31, 2006) (SR-BSE-2006-19) (extending the Program until
June 5, 2007); Securities Exchange Act Release No. 55684 (Apr. 30,
2007), 72 FR 26188 (May 8, 2007) (SR-BSE-2007-17) (extending the
Program until June 5, 2008). The Program was subsequently expanded
and permanently approved in 2008. See Securities Exchange Act
Release No. 57302 (Feb. 11, 2008), 73 FR 8913 (Feb. 15, 2008) (SR-
BSE-2008-08). The Pilot Program was last expanded in 2009. See
Securities Exchange Act Release No. 59589 (Mar. 17, 2009), 73 FR
8913 (Mar. 24, 2009) (SR-BSE-2009-16).
    \6\ LEAPS are long-term options that have from twelve to thirty-
nine months from the time they are listed until expiration. See
Chapter IV, Section 8(a) Long-Term Equity Option Series
(LEAPS[reg]).
    \7\ Supplementary Material .02(c) to Chapter IV, Section 6 of
the BOX Rules states that the Exchange may list $1 strike prices up
to $5 in LEAPS in up to 200 option classes in individual stocks. See
Securities Exchange Act Release No. 61041 (Nov. 20, 2009) 75 FR
62623 (Nov. 30, 2009) (SR-BSE-2009-073).
    \8\ Regarding the $0.50 Strike Program, which allows $0.50
strike price intervals for options on stocks trading at or below
$3.00, see Supplementary Material .02 to Chapter IV, Section 6(a)
and Securities Exchange Act Release No. 60814 (Oct. 13, 2009), 74 FR
53535 (Oct. 19, 2009) (SR-BSE-2009-063). See also Securities
Exchange Act Release No. 61811 (Mar. 31, 2010), 75 FR 17802 (April
7, 2010) (SR-BSE-2010-025) (permitting concurrent listing of $3.50
and $4 strikes for classes in the $0.50 Strike and $1 Strike
Programs).

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

    The Exchange now proposes to expand the Program to allow BOX to
select a total of 150 individual stocks on which option series may be
listed at $1 strike price intervals. The existing restrictions on
listing $1 strikes would continue, i.e., no $1 strike price may be
listed that is greater than $5 from the underlying stock's closing
price in its primary market on the previous day, and BOX is restricted
from listing any series that would result in strike prices being $0.50
apart (unless an option class is selected to participate in both the $1
Strike Program and the $0.50 Strike Program).
    As stated in the filings establishing BOX's Program and in
subsequent extensions and expansions of the Program,\9\ BOX believes
that $1 strike price intervals provide investors with greater
flexibility in the trading of equity options that overlie lower price
stocks by allowing investors to establish equity options positions that
are better tailored to meet their investment objectives.
---------------------------------------------------------------------------

    \9\ See supra note 5.
---------------------------------------------------------------------------

    BOX believes that market conditions have led to an increase in the
number of securities trading below $50 warranting the proposed
expansion of the $1 Strike Program.\10\ In addition, BOX notes that
this filing is based on rules of other options exchanges, such as,
NASDAQ OMX PHLX, Inc (``PHLX''), Chicago Board Options Exchange
(``CBOE''), International Securities Exchange, LLC (``ISE''), NYSE
Arca, Inc. (``NYSE Arca''), NYSE Amex LLC (``NYSE Amex''), and NASDAQ
Options Market (``NOM'').\11\ With regard to previous expansions of the
Program, the Commission has approved proposals from the options
exchanges that employ a $1 Strike Program in lockstep.
---------------------------------------------------------------------------

    \10\ See, e.g., Securities Exchange Act Release No. 59589 (Mar.
17, 2009), 73 FR 8913 (Mar. 24, 2009) (SR-BSE-2009-16) (referencing
the more than five-fold increase in the number of individual stocks
on which options may be listed at $1 intervals).
    \11\ See Securities Exchange Act Release No. 62420 (June 30,
2010), 75 FR 39593 (July 9, 2010) (SR-Phlx-2010-72); Securities
Exchange Act Release No. 62443 (July 2, 2010), 75 FR 39608 (July 9,
2010) (SR-CBOE-2010-64); Securities Exchange Act Release No. 62442
(July 2, 2010), 75 FR 39597 (July 9, 2010) (SR-ISE-2010-64);
Securities Exchange Act Release No. 62450 (July 2, 2010), 75 FR
39712 (July 12, 2010) (SR-NYSEArca-2010-66); Securities Exchange Act
Release No. 62449 (July 2, 2010) (SR-NYSEAmex-2010-67); Securities
Exchange Act Release No. 62451 (July 6, 2010) (SR-NASDAQ-2010-83).
---------------------------------------------------------------------------

    The Exchange notes that, in addition to options classes that are
trading pursuant to the $1 strike programs of options exchanges, there
are also options trading at $1 strike intervals on BOX on over 95
exchange-traded fund shares (``ETFs'') and exchange-traded notes
(ETNs''),\12\ ETF and ETN options trading at $1 intervals have not,
however, negatively impacted the system capacity of BOX or OPRA.
---------------------------------------------------------------------------

    \12\ See Supplementary Material .01 to Chapter IV, Section 6 of
the BOX Rules (allowing $1 strike price intervals for ETF and ETN
options where the strike price is $200 or less).
---------------------------------------------------------------------------

    With regard to the impact of this proposal on system capacity, BOX
has analyzed its capacity and the Exchange represents that it and OPRA
have the necessary systems capacity to handle the potential additional
traffic associated with the listing and trading of an expanded number
of series in the $1 Strike Program.
    BOX believes that the $1 Strike Program has provided investors with
greater trading opportunities and flexibility and the ability to more
closely tailor their investment and risk management strategies and
decisions to the movement of the underlying security. Furthermore, BOX
has not detected any material proliferation of illiquid options series
resulting from the narrower strike price intervals. For these reasons,
BOX requests an expansion of the current Program and the opportunity to
provide investors with additional strikes for investment, trading, and
risk management purposes.
2. Statutory Basis
    The Exchange believes that the proposal is consistent with the
requirements of Section 6(b) of the Act,\13\ in general, and Section
6(b)(5) of the Act,\14\ in particular, in that it is designed to foster
cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities, to remove impediments to and
perfect the mechanism for a free and open market and a national market
system and, in general, to protect investors and the public interest.
In particular, the Exchange believes that expanding the current $1
Strike Program will result in a continuing benefit to investors by
giving them more flexibility to closely tailor their investment
decisions in a greater number of securities.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78f(b).
    \14\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition 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

    The Exchange has neither solicited nor received comments on the
proposed rule change.

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

    Because the foregoing proposed rule change does not significantly
affect the protection of investors or the public interest, does not
impose any significant burden on competition, and, by its terms, does
not become operative for 30 days from the date on which it was filed,
or such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \15\ and Rule 19b-
4(f)(6) thereunder.\16\
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78s(b)(3)(A).
    \16\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires the Exchange to give the Commission written notice of the
Exchange's intent to file the proposed rule change, along with a
brief description and text of the proposed rule change, at least
five business days prior to the date of filing of the proposed rule
change, or such shorter time as designated by the Commission. The
Commission has waived the five-day pre-filing requirement in this
case.
---------------------------------------------------------------------------

    The Exchange has requested that the Commission waive the 30-day
operative delay. The Commission believes that waiver of the operative
delay is consistent with the protection of investors and the public
interest because the proposal is substantially similar to that of
another exchange that has been approved by the Commission.\17\
Therefore, the Commission designates the proposal operative upon
filing.\18\
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    \17\ See Securities Exchange Act Release No. 62420 (June 30,
2010), 75 FR 39593 (July 9, 2010) (SR-Phlx-2010-72) (order approving
expansion of $1 strike program to 150 classes).
    \18\ 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. See 15 U.S.C.
78c(f).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the 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-BX-2010-050 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-BX-2010-050. 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 Web site viewing and
printing 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 the filing also will be available for
inspection and copying at the principal office of the Exchange. 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 available publicly. All
submissions should refer to File Number SR-BX-2010-050 and should be
submitted on or before August 19, 2010.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\19\
---------------------------------------------------------------------------

    \19\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
[FR Doc. 2010-18572 Filed 7-28-10; 8:45 am]
BILLING CODE 8010-01-P