"Andrew Hackman"<EMAIL_ADDRESS>
02/15/2008 04:59 PM	To

	Margaret Sheppard/DC/USEPA/US@EPA

	cc

	"'Doug Fratz'"<EMAIL_ADDRESS>
	bcc

	Subject

	RE: Supplemental CSPA Comments on Docket ID No. EPA-HQ-OAR-2002-0064

	History:

		This message has been replied to.

Margaret,

Sorry for the delayed response I have been traveling this week and
soliciting clarification from our members.

As you have seen from the data in our comments, end-users typically
apply n-PB aerosols in short bursts lasting a second or less (dispensing
only a few grams) onto various electronic and electrical parts
throughout a manufacturing plant on an as-needed basis. Most of the time
a cleaning application is made directly to components of the
manufacturing equipment itself to eliminate electrical shorts or the
physical jamming of mechanical equipment.

Therefore, "generally well ventilated" implies general plant
ventilation.  In these situations, fans and standard HVAC ventilation
systems provide building-wide ventilation.

In the limited case where use of an entire aerosol product or more (such
as Facility D) was witnessed, well ventilated referenced specific
exhaust ventilation and fume hoods.

I hope this is helpful.

Thank you,

Andy Hackman

Director of State Affairs

The Consumer Specialty Products Association

Phone:<PHONE_NUMBER>

Fax:<PHONE_NUMBER>

Cell:<PHONE_NUMBER>

Confidentiality Notice: This e-mail message (including any attachments)
contains information from the Consumer Specialty Products Association
(CSPA)

and is covered by the Electronic Communications Privacy Act, 18 U.S.C.

2510-21, and is intended only for the named recipient (or recipients)
and

CSPA member companies. This e-mail, including any attachments or
hyperlinks

within it, may contain information that is confidential or otherwise

protected from disclosure. If you are not the intended recipient of this

email, you are not entitled to use, disclose, distribute, copy, print,

disseminate or rely on this email in any way. Even if you are the
intended

recipient or a CSPA member company, you may not distribute, disclose or

otherwise disseminate this email or its attachments outside the
membership

of CSPA, without CSPA's prior written consent.

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

From<EMAIL_ADDRESS>
<EMAIL_ADDRESS>
Sent: Monday, February 04, 2008 5:01 PM

To: Andrew Hackman

Subject: RE: Supplemental CSPA Comments on Docket ID No.

EPA-HQ-OAR-2002-0064

Andrew,

Thanks for your follow-up.

I have another question after looking at the surveys, particularly
appendix B.  For question 5, I would like clarification what the
customers are likely to mean when they respond that the area is
"generally well ventilated."  For example, is this likely to mean that
there are fans and regional ventilation systems but not specific exhaust
ventilation and not fume hoods?  Is there agreement among users about
what "generally well ventilated" means, either quantitatively or in
terms of equipment used?

I expect to have a better idea of the status after talking with my new
boss, who starts later this month.

Margaret Sheppard

USEPA/Stratospheric Protection Division

SNAP Program

Tel.<PHONE_NUMBER>

Fax<PHONE_NUMBER>

email<EMAIL_ADDRESS>

             "Andrew Hackman"

<EMAIL_ADDRESS>

             rg>                                                     To

                                      Margaret Sheppard/DC/USEPA/US@EPA

             02/04/2008 09:37                                        cc

             AM

                                                                Subject

                                      RE: Supplemental CSPA Comments on

                                      Docket ID No.

                                      EPA-HQ-OAR-2002-0064

Margaret,

Now that we are into 2008, I wanted to touch base and see what the
status is of the proposed rule on nPB in aerosol products.

Please let me know if there is anything else that we can do or provide.

If

it is of interest we could also try and pull together a meeting of our
members to discuss any concerns that the Agency still has.

Thanks again,

Andy Hackman

Director of State Affairs

The Consumer Specialty Products Association

Phone:<PHONE_NUMBER>

Fax:<PHONE_NUMBER>

Cell:<PHONE_NUMBER>

Confidentiality Notice: This e-mail message (including any attachments)
contains information from the Consumer Specialty Products Association
(CSPA) and is covered by the Electronic Communications Privacy Act, 18
U.S.C. 2510-21, and is intended only for the named recipient (or
recipients) and CSPA member companies. This e-mail, including any
attachments or hyperlinks within it, may contain information that is
confidential or otherwise protected from disclosure. If you are not the
intended recipient of this email, you are not entitled to use, disclose,
distribute, copy, print, disseminate or rely on this email in any way.
Even if you are the intended

recipient or a CSPA member company, you may not distribute, disclose or
otherwise disseminate this email or its attachments outside the
membership of CSPA, without CSPA's prior written consent.

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

From<EMAIL_ADDRESS>
<EMAIL_ADDRESS>
Sent: Friday, December 07, 2007 2:02 PM

To: Andrew Hackman

Cc: 'Doug Fratz'

Subject: RE: Supplemental CSPA Comments on Docket ID No.

EPA-HQ-OAR-2002-0064

Andy,

Thanks again for checking to see if we have any further questions.  So
far, I have just one question:  were any of the four facilities for
which you provided exposure data also included among the 29 customers in
the profiles?

I am aiming to complete a draft document for internal EPA review before
the end of the year.    Our current schedule is for a final rule in
summer of 2008.

Margaret Sheppard

USEPA/Stratospheric Protection Division

SNAP Program

Tel.<PHONE_NUMBER>

Fax<PHONE_NUMBER>

email<EMAIL_ADDRESS>
             "Andrew Hackman"

<EMAIL_ADDRESS>
             rg>                                                     To

                                      Margaret Sheppard/DC/USEPA/US@EPA

             11/29/2007 02:40                                        cc

             PM                       "'Doug Fratz'"<EMAIL_ADDRESS>
                                                                Subject

                                      RE: Supplemental CSPA Comments on

                                      Docket ID No.

                                      EPA-HQ-OAR-2002-0064

Margaret,

Thank you again for the opportunity to submit our supplemental comments
earlier this month.  I wanted to touch base with you again and see if
you or anyone else from your office has had any questions about the
additional data and comments that we submitted.

I also wanted to see if there is a timeline for future action on this
issue.

Thanks again for including us in this process.

Andy Hackman

Manager of State Affairs Programs

The Consumer Specialty Products Association

Phone:<PHONE_NUMBER>

Fax:<PHONE_NUMBER>

Cell:<PHONE_NUMBER>

Confidentiality Notice: This e-mail message (including any attachments)
contains information from the Consumer Specialty Products Association
(CSPA) and is covered by the Electronic Communications Privacy Act, 18
U.S.C. 2510-21, and is intended only for the named recipient (or
recipients) and CSPA member companies. This e-mail, including any
attachments or hyperlinks within it, may contain information that is
confidential or otherwise protected from disclosure. If you are not the
intended recipient of this email, you are not entitled to use, disclose,
distribute, copy, print, disseminate or rely on this email in any way.
Even if you are the intended

recipient or a CSPA member company, you may not distribute, disclose or
otherwise disseminate this email or its attachments outside the
membership of CSPA, without CSPA's prior written consent.

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

From<EMAIL_ADDRESS>
<EMAIL_ADDRESS>
Sent: Monday, November 19, 2007 10:41 AM

To: Andrew Hackman

Cc: 'Doug Fratz'

Subject: Re: Supplemental CSPA Comments on Docket ID No.

EPA-HQ-OAR-2002-0064

Mr. Hackman and Mr. Fratz,

I received your supplemental comments.  Thank you for working together

with your members to provide us this information.  I am looking forward
to reading through it.

Sincerely,

Margaret Sheppard

USEPA/Stratospheric Protection Division

SNAP Program

Tel.<PHONE_NUMBER>

Fax<PHONE_NUMBER>

email<EMAIL_ADDRESS>


[Federal Register: October 10, 2006 (Volume 71, Number 195)]
[Notices]
[Page 59502-59503]
[DOCID:fr10oc06-52]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM98-1-000]

Records Governing Off-the-Record Communications; Public Notice

October 2, 2006.
    This constitutes notice, in accordance with 18 CFR 385.2201(b), of
the receipt of prohibited and exempt off-the-record communications.
    Order No. 607 (64 FR 51222, September 22, 1999) requires Commission
decisional employees, who make or receive a prohibited or exempt off-
the-record communication relevant to the merits of a contested
proceeding, to deliver to the Secretary of the Commission, a copy of
the communication, if written, or a summary of the substance of any
oral communication.
    Prohibited communications are included in a public, non-decisional
file associated with, but not a part of, the decisional record of the
proceeding. Unless the Commission determines that the prohibited
communication and any responses thereto should become a part of the
decisional record, the prohibited off-the-record communication will not
be considered by the Commission in reaching its decision. Parties to a
proceeding may seek the opportunity to respond to any facts or
contentions made in a prohibited off-the-record communication, and may
request that the Commission place the prohibited communication and
responses thereto in the decisional record. The Commission will grant
such a request only when it determines that fairness so requires. Any
person identified below as having made a prohibited off-the-record
communication shall serve the document on all parties listed on the
official service list for the applicable proceeding in accordance with
Rule 2010, 18 CFR 385.2010.
    Exempt off-the-record communications are included in the decisional
record of the proceeding, unless the communication was with a
cooperating agency as described by 40 CFR 1501.6, made under 18 CFR
385.2201(e)(1)(v).

    The following is a list of off-the-record communications recently
received by the Secretary of the Commission. The communications listed
are grouped by docket numbers in ascending order. These filings are
available for review at the Commission in the Public Reference Room or
may be viewed on the Commission's Web site at http://www.ferc.gov using

the eLibrary link. Enter the docket number, excluding the last three
digits, in the docket number field to access the document. For
assistance, please contact FERC, Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,

contact<PHONE_NUMBER>.

------------------------------------------------------------------------
         Docket number            Date received   Presenter or requester
------------------------------------------------------------------------
                               Prohibited
------------------------------------------------------------------------
1. Project No. 637-022.........         9-29-06  Terry Luker
------------------------------------------------------------------------
                                 Exempt
------------------------------------------------------------------------
1. CP05-130-000................         9-19-06  Hon. Barbara A.
                                                  Mikulski.
2. CP06-12-000, CP06-13-000,            9-29-06  E.M. Staunton.
 CP06-14-000.
3. CP06-275-000................         9-20-06  Hon. Charlie Borders.
4. CP06-275-000................         9-25-06  Hon. Joey Pendleton.
5. CP06-275-000................         9-25-06  Hon. Dorsey Ridley.
6. ER06-615-000................         9-19-06  Hon. Peter DeFazio,
                                                  Hon. Doc Hastings,
                                                  Hon. Norm Dicks, Hon.
                                                  Greg Walden, Hon. Jim
                                                  McDermott, Hon. David
                                                  Reichert, Hon. Jay
                                                  Inslee, Hon. Cathy
                                                  McMorris, Hon. Darlene
                                                  Hooley, Hon. Jon
                                                  Porter, Hon. Adam
                                                  Smith, Hon. Stevan
                                                  Pearce, Hon. Brian
                                                  Baird, Hon. Rick
                                                  Larsen, Hon. Jim
                                                  Gibbons.
7. ER06-615-000................         9-20-06  Hon. Jeff Hatch-Miller,
                                                  Hon. William A.
                                                  Mundell, Hon. Kristin
                                                  K. Mayes, Hon. Barry
                                                  Wong.
8. ER06-615-000................         9-21-06  Hon. John Shadegg, Hon.
                                                  J.D. Hayworth, Hon.
                                                  Jeff Flake, Hon. Trent
                                                  Franks, Hon. Rick
                                                  Renzi.
9. PF06-30-000.................         9-27-06  Maurice A. Hartley.\1\
10. Project No. 1637-000.......         9-15-06  Hon. Patty Murray, Hon.
                                                  Doc Hastings.
11. Project No. 1971-079.......         9-27-06  Alan Mitchnick.
12. Project No. 2216-066.......         7-06-06  Mr. and Mrs. James J.
                                                  Trzaska.
13. Project No. 12657-000......          9-1-06  Hon. Geoff Davis.
------------------------------------------------------------------------
\1\ This is one letter among similar correspondence (e-mails, letters,
  scoping meeting summary) placed in the record in this proceeding on
  September 27, 2006.

Magalie R. Salas,
Secretary.
[FR Doc. E6-16619 Filed 10-6-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 37 (Wednesday, February 25, 2015)]
[Notices]
[Pages 10122-10123]
[FR Doc No: 2015-03843]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-0230]

Technical Performance Assessment of Digital Pathology Whole Slide
Imaging Devices; Draft Guidance for Industry and Food and Drug
Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled ``Technical Performance
Assessment of Digital Pathology Whole Slide Imaging Devices.'' This
draft guidance provides industry and Agency staff with recommendations
regarding the technical performance assessment data that should be
provided for regulatory evaluation of a digital whole slide imaging
(WSI) system. This draft guidance is not final nor is it in effect at
this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment of this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by May 26, 2015.

ADDRESSES: 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 draft guidance document entitled
``Technical Performance Assessment of Digital Pathology Whole Slide
Imaging Devices'' to the Office of the Center Director, Guidance and
Policy Development, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431,
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to
assist that office in processing your request.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Nicholas Anderson, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5570, Silver Spring, MD 20993-0002, 301-
796-4310; or Aldo Badano, Center for Devices and Radiological Health,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 62, Rm.
3116, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Recent technological advances in digital microscopy, in particular
the development of whole slide scanning systems, have accelerated the
adoption of digital imaging in pathology, similar to the digital
transformation that radiology departments have experienced over the
last decade. FDA regulates WSI systems manufacturers to ensure that the
images produced for clinical intended uses are safe and effective for
such purposes. Essential to the regulation of these systems is the
understanding of the technical performance of the components in the
imaging chain, from image acquisition to image display and their effect
on pathologist's diagnostic performance and workflow.
    This draft guidance provides industry and Agency staff with
recommendations regarding the technical performance assessment data
that should be included for regulatory evaluation of a WSI. This
document does not cover the clinical submission data that may be
necessary to support approval or clearance. The guidance provides our
suggestions on how to best characterize the technical aspects that are
relevant to WSI performance for their intended use and determine any
possible limitations that might affect their safety and effectiveness.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on technical
performance assessment of digital pathology WSI devices. It does not
create or confer any rights for or on any person and does not operate
to bind FDA or the public. An alternative approach may be used if such
approach satisfies the requirements of the applicable statute and
regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the Internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. Persons
unable to download an electronic copy of ``Technical Performance
Assessment of Digital Pathology Whole Slide Imaging Devices'' may send
an email request to<EMAIL_ADDRESS>to receive an electronic
copy of the document. Please use the document number 1400053 to
identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-
3520). The collections of information in 21 CFR part 807, subpart E
have been approved under OMB control number 0910-0120, the collections
of information in 21 CFR part 814 have been approved under OMB control
number 0910-0231, and the collections of information in 21 CFR part 801
and 21 CFR 809.10 have been approved under OMB control number 0910-
0485.

V. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). 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. 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.

    Dated: February 19, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-03843 Filed 2-24-15; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 167 (Thursday, August 27, 2020)]
[Notices]
[Pages 53035-53036]
[FR Doc No: 2020-18803]

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

SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-777, OMB Control No. 3235-0729]

Submission for OMB Review; Comment Request

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

Extension:
    Form N-CEN

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (the ``Commission'') has submitted to the Office of
Management and Budget a request for extension of the previously
approved collection of information discussed below.
    The title for the collection of information is ``Form N-CEN under
the Investment Company Act of 1940.'' Form N CEN is used to collect
annual, census-type information for registered funds. Filers must
submit this report electronically using the Commission's electronic
filing system ``(EDGAR'') in Extensible Markup Language (``XML'')
format. The purpose of Form N-CEN is to satisfy the filing and
disclosure requirements of Section 30 of the Investment Company Act,
and of rule 30a-1 thereunder.
    We estimate that the average annual hour burden to complete the
generally applicable items on Form N-CEN response will be 12.31 hours
per year. We estimate that the aggregate annual hour burden to complete
the generally applicable items will be 34,899 hours per year. We
therefore estimate that filers would have total average annualized
paperwork related expenses related to complete the generally applicable
items of $12,249,496.35 for reports on Form N-CEN. Additionally, we
estimate that filers will be required to file 12,365 responses related
to liquidity risk management items on Form N-CEN. We estimate that the
average annual hour burden of the liquidity risk management items on
Form N-CEN will be one hour per response per year, for an additional
average annual hour burden of 12,365 hours and average aggregate time
costs of $4,340,115. Additionally, we estimate that filers will be
required to file 9,854 responses regarding swing pricing. We estimate
that the average annual hour burden as a result of the swing pricing-
related items on Form N-CEN will be an additional 0.5 hour per fund per
year for

an average annual hour burden of 4,927 hours and average aggregate time
costs of $1,729,377. We estimate that filers will be required to file
2,091 responses regarding rule 6c-11. For these responses related to
rule 6c-11, we an average annual hour burden of 0.1 hour per response
per year, for an average annual hour burden of 209.1 hours and average
aggregate time costs of $73,394.1.
    We estimate that the total hour burdens and time costs associated
with Form N-CEN, including the burdens associated with the liquidity-
related, swing pricing-related, and rule 6c-11-related items, will
result in an average annual hour burden of 52,397 hours and average
aggregate time costs of $18,392,382.45.
    The requirements of this collection of information are mandatory.
Responses will not be kept confidential. An agency may not conduct or
sponsor, and a person is not required to respond to a collection of
information unless it displays a currently valid control number.
    The public may view background documentation for this information
collection at the following website: www.reginfo.gov. Find this
particular information collection by selecting ``Currently under 30-day
Review--Open for Public Comments'' or by using the search function.
Written comments and recommendations for the proposed information
collection should be sent within 30 days of publication of this notice
to (i) www.reginfo.gov/public/do/PRAMain and (ii) David Bottom,
Director/Chief Information Officer, Securities and Exchange Commission,
c/o Cynthia Roscoe, 100 F Street NE, Washington, DC 20549, or by
sending an email to<EMAIL_ADDRESS>
    Dated: August 21, 2020.
J. Matthew DeLesDernier,
Assistant Secretary.
[FR Doc. 2020-18803 Filed 8-26-20; 8:45 am]
BILLING CODE 8011-01-P