[Federal Register Volume 84, Number 99 (Wednesday, May 22, 2019)]
[Notices]
[Pages 23585-23586]
[FR Doc No: 2019-10625]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2016-0005]

Preparations for the 37th Session of the UN Sub-Committee of
Experts on the Globally Harmonized System of Classification and
Labelling of Chemicals (UNSCEGHS)

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Notice of public meeting.

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SUMMARY: This notice is to advise interested persons that on Thursday,
June 20, 2019, OSHA will conduct a public meeting to discuss proposals
in preparation for the 37th session of the United Nations Sub-Committee
of Experts on the Globally Harmonized System of Classification and
Labelling of Chemicals (UNSCEGHS) to be held July 8 through July 10,
2019, in Geneva, Switzerland. OSHA, along with the U.S. Interagency
Globally Harmonized System of Classification and Labelling of Chemicals
(GHS) Coordinating Group, plans to consider the comments and
information gathered at this public meeting when developing the U.S.
Government positions for the UNSCEGHS meeting. OSHA also will give an
update on the Regulatory Cooperation Council (RCC).
    Also on Thursday, June 20, 2019, the Department of Transportation
(DOT), Pipeline and Hazardous Materials Safety Administration (PHMSA)
will conduct a public meeting (See 84 FR 11865, March 28, 2019) to
discuss proposals in preparation for the 55th session of the United
Nations Sub-Committee of Experts on the Transport of Dangerous Goods
(UNSCE TDG) to be held July 1 through July 5, 2019, in Geneva,
Switzerland. During this meeting, PHMSA is also requesting comments
relative to potential new work items that may be considered for
inclusion in its international agenda. PHMSA will also provide an
update on recent actions to enhance transparency and stakeholder
interaction through improvements to the international standards portion
of its website.

DATES: The PHMSA public meeting will be held on June 20, 2019, 9:00
a.m. to 12:00 p.m., ET. The OSHA public meeting will also be held June
20, 2019, 1:00 p.m. to 4:00 p.m., ET.

ADDRESSES: Both meetings will be held at the DOT Headquarters
Conference Center, West Building, Oklahoma City Conference Room, 1200
New Jersey Avenue SE, Washington, DC 20590.
    Written Comments: Interested parties may submit comments by July 8,
2019, on the Working and Informal Papers for the 37th session of the
UNSCEGHS to the docket established for International/Globally
Harmonized System (GHS) efforts at: http://www.regulations.gov, Docket
No. OSHA-2016-0005.
    Registration To Attend and/or To Participate in the Meeting: DOT
requests that attendees pre-register for these meetings by completing
the form at: https://www.surveymonkey.com/r/TM8VS3B. Attendees may use
the same form to pre-register for both meetings. Failure to pre-
register may delay your access into the DOT Headquarters building.
Additionally, if you are attending in person, arrive early to allow
time for security checks necessary to access the building. Conference
call-in and ``Skype meeting'' capability will be provided for both
meetings. Information on how to access the conference call and ``Skype
meeting'' will be posted when available at: https://www.phmsa.dot.gov/international-program/international-program-overview under Upcoming
Events. This information will also be posted on OSHA's Hazard
Communication website on the international tab at: https://www.osha.gov/dsg/hazcom/hazcom_international.html#meeting-notice.

FOR FURTHER INFORMATION CONTACT:
    At the Department of Transportation: Please contact Mr. Steven Webb
or Mr. Aaron Wiener, Office of Hazardous Materials Safety, Department
of Transportation, Washington, DC 20590, telephone:<PHONE_NUMBER>.
    At the Department of Labor: Please contact Ms. Maureen Ruskin, OSHA
Directorate of Standards and Guidance, Department of Labor, Washington,
DC 20210, telephone:<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

The OSHA Meeting

    OSHA is hosting an open informal public meeting of the U.S.
Interagency GHS Coordinating Group to provide interested groups and
individuals with an update on GHS-related issues and an opportunity to
express their views orally and in writing for consideration in
developing U.S. Government positions for the upcoming UNSCEGHS meeting.
    General topics on the agenda include:

 Review of Working Papers
 Correspondence Group updates
 Regulatory Cooperation Council (RCC) update

    Information on the work of the UNSCEGHS including meeting agendas,
reports, and documents from previous sessions can be found on the
United Nations Economic Commission for Europe (UNECE) Transport
Division website located at the following web address: http://www.unece.org/trans/danger/publi/ghs/ghs_welcome_e.html.
    The UNSCEGHS bases its decisions on Working Papers. The Working
Papers for the 37th session of the UNSCEGHS are located at: https://www.unece.org/trans/main/dgdb/dgsubc4/c42019.html.
    Informal Papers submitted to the UNSCEGHS provide information for
the Sub-Committee and are used either as a mechanism to provide
information to the Sub-Committee or as the basis for future Working
Papers. Informal Papers for the 37th session of the UNSCEGHS are
located at: https://www.unece.org/trans/main/dgdb/dgsubc4/c4inf37.html.

The PHMSA Meeting

    The Federal Register notice and additional detailed information
relating to PHMSA's public meeting will be available upon publication
at: http://www.regulations.gov (Docket No. PHMSA-2018-0113), and on the
PHMSA website at: https://www.phmsa.dot.gov/international-program/international-program-overview.
    The primary purpose of PHMSA's meeting is to prepare for the 55th
session of the UNSCE TDG. This session represents the first meeting
scheduled for the 2019-2020 biennium. UNSCE will consider proposals for
the 21st Revised Edition of the United Nations Recommendations on the
Transport of Dangerous Goods (Model Regulations), which may be
implemented into relevant domestic, regional, and international
regulations from January 1, 2021. Copies of working documents, informal
documents, and the meeting agenda may be obtained from the United
Nations (UN) Transport Division's website at: https://www.unece.org/trans/main/dgdb/dgsubc3/c32019.html.
    During this meeting, PHMSA is also soliciting input relative to
preparing for the 55th session of the UNSCE TDG as well as potential
new work items which may be considered for inclusion in its
international agenda. Following the 55th session of the UNSCE TDG, a
copy

of the Sub-Committee's report will be available at the UN Transport
Division's website at: http://www.unece.org/trans/main/dgdb/dgsubc3/c3rep.html.
    Additional information regarding the UNSCE TDG and related matters
can be found on PHMSA's website at: https://www.phmsa.dot.gov/international-program/international-program-overview.

Authority and Signature

    Loren Sweatt, Acting Assistant Secretary for Occupational Safety
and Health, U.S. Department of Labor, authorized the preparation of
this notice under the authority granted by sections 4, 6, and 8 of the
Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657),
and Secretary's Order 1-2012 (77 FR 3912), (Jan. 25, 2012).

    Signed at Washington, DC, on May 16, 2019.
Loren Sweatt,
Acting Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2019-10625 Filed 5-21-19; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register: October 17, 2005 (Volume 70, Number 199)]
[Notices]
[Page 60333-60334]
[DOCID:fr17oc05-85]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. AD05-14-000]

State of the Natural Gas Infrastructure Conference; Supplemental
Notice of Public Conference

October 6, 2005.
    As announced in a Notice of Technical Conference issued on
September 9, 2005, in the above referenced proceeding, a technical
conference will be held on October 12, 2005, from approximately 9 a.m.
until 1:30 p.m. (EST) (a change in closing time from 3 p.m. listed in
the previous notice). The conference will be held in the Commission
Meeting Room on the second floor of the offices of the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC. All
interested persons may attend; there is no fee or registration.
Commissioners are expected to participate. Attached is the agenda for
the conference.
    Transcripts of the conference will be immediately available from
Ace Reporting Company<PHONE_NUMBER> or 1-800-336-6646) for a fee. They
will be available for the public on the Commission's eLibrary system
seven calendar days after FERC receives the transcript. Additionally,
Capitol Connection offers the opportunity for remote listening and
viewing of the conference. It is available for a fee, live over the
Internet, by phone, or via satellite. Persons interested in receiving
the broadcast, or who need information on making arrangements should
contact David Reininger or Julia Morelli at the Capitol Connection
(703-993-3100) as soon as possible or visit the Capitol Connection Web
site at http://www.capitolconnection.gmu.edu and click on ``FERC.''

    FERC conferences are accessible under section 508 of the
Rehabilitation Act of 1973. For accessibility accommodations please
send an e-mail to<EMAIL_ADDRESS>or call toll free<PHONE_NUMBER>
(voice) or<PHONE_NUMBER> (TTY), or send a fax to<PHONE_NUMBER> with the
required accommodations.
    For more information about the conference, please contact John
Schnagl at<PHONE_NUMBER><EMAIL_ADDRESS>or Sarah McKinley at
(202) 502-8004 (sarah.mckinley@ferc.gov).

Magalie R. Salas,
Secretary.

State of the Natural Gas Infrastructure Conference

Agenda

October 12, 2005
9 a.m.--Opening Remarks
    Chairman Joseph T. Kelliher, Federal Energy Regulatory Commission.
9:15 a.m.--Presentation on Short-Term Price Effects of Recent
Hurricanes
    Stephen Harvey, Robert Flanders and Dean Wight, Office of Market
Oversight and Investigations, FERC.
9:40 a.m.--Panel I: Katrina, Rita and the Winter Beyond
    What energy infrastructure damage caused by Hurricanes Katrina and
Rita still needs repair and what are the prospects for the coming
winter?
    Hurricanes Katrina and Rita have had significant impacts on the
nation's natural gas infrastructure. What lessons were learned from
these natural disasters, and how can they be applied to the country as
a whole?
    Panelists: R. Skip Horvath, President and CEO, Natural Gas Supply
Association; David Halphen, Vice President Regulatory Affairs and
Administration, Enbridge Offshore Pipelines; Martha Wyrsch, President
and CEO, Duke Energy Transmission Corp., on behalf of Interstate
Natural Gas Association of America; David Manning, Senior Vice
President, Corporate Affairs, Keyspan Energy, on behalf of the American
Gas Association; and Patrick DeVille, Director of Marketing, ENSTOR.
10:45 a.m.--Panel II: State of the Pipeline Industry
    Given the evolution of the pipeline industry, financial conditions
and current contracting practices, can the pipeline industry construct
sufficient infrastructure to meet projected demands and the changing
sources of supply, e.g., LNG and Rockies gas?

    Beginning in 1992, the pipeline industry underwent a major
transformation with the passage of Order No. 636. Order No. 637 and the
Certificate Policy Statement further spurred the evolution of the
industry. Then the 2000-2001 energy crisis was followed by a post-
crisis credit crunch. The traditional model of long-term contracts at
cost-based rates has been increasingly replaced by short-term contracts
at negotiated rates. As a result, the face of the pipeline industry has
changed with consolidations and acquisitions by financial investors and
diversified companies.
    Panelists: Commissioner Donald Mason, Ohio Public Utilities
Commission and Chair of the NARUC Gas Committee; James Cleary,
President, Western Pipelines, El Paso Corporation; Michael Walsh,
Managing Director, AIG Highstar; Scott Parker, President, Natural Gas
Pipelines, Kinder Morgan; and Todd Shipman, Director, Energy & Project
Finance, Standard & Poor's.
11:50 a.m.--Panel III: Future of the Pipeline Industry
    What changes in current regulatory policies might improve the
economic and regulatory environment in order to spur interstate
pipeline development?
    Developments in response to expected increases in natural gas
demand will bring natural gas to the U.S. via LNG imports or from
unconventional sources of domestic gas. However, there must be an
adequate transmission system--interstate pipelines--to deliver this gas
to the distribution companies and the end users.
    Panelists: Martha Wyrsch, President and CEO, Duke Energy Gas
Transmission, on behalf of the Interstate Natural Gas Association of
America; Larry Bickle, Managing Director, Haddington Ventures, LLC;
James Wilson, Principal, LECG, LLC; Richard Smead, Director, Navigant
Consulting Inc.; Alex Strawn, Chairman, Process Gas Consumers Group;
Sam Brothwell, Director, Equity Research-Electric & Gas Utilities,
Wachovia; and Michael Gildea, Constellation Generation on behalf of
Electric Power Supply Association.
12:55 p.m.--Open Forum
1:15 p.m.--Closing Remarks
1:30 p.m.--Adjourn
 [FR Doc. E5-5669 Filed 10-14-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: February 7, 2007 (Volume 72, Number 25)]
[Notices]
[Page 5696]
[DOCID:fr07fe07-73]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 11858-002]

Elsinore Municipal Water District and the Nevada Hydro Company,
Inc, CA; Notice of Availability of the Final Environmental Impact
Statement for the Proposed Lake Elsinore Advanced Pumped Storage
Project

January 30, 2007.
    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) has prepared the final Environmental Impact Statement (EIS)
Lake Elsinore Advanced Pumped Storage Project in the above-referenced
docket.
    The final EIS was prepared to satisfy the requirements of the
National Environmental Policy Act of 1969, as amended, and the FERC
regulations, 18 CFR Part 380. The Office of Energy Projects has
reviewed the application for license for the proposed Lake Elsinore
Advanced Pumped Storage Project, located on Lake Elsinore and San Juan
Creek, in the Town of Lake Elsinore, Riverside County, California.
    In the final EIS, Commission staff evaluated the co-applicant's
proposal and the alternatives for licensing the proposed project. The
final EIS documents the views of governmental agencies, non-
governmental organizations, affected Indian tribes, the public, the
license applicants, and Commission staff.
    Copies are available for review in Public Reference Room 2-A of the
Commission's offices at 888 First Street, NE., Washington, DC. The EIS
also may be viewed on the Commission's Internet Web site (http://www.ferc.gov
) using the ``eLibrary'' link. Additional information about

the project is available from the Commission's Office of External
Affairs at<PHONE_NUMBER>, or on the Commission's Web site using the
eLibrary link. For assistance with eLibrary, contact
<EMAIL_ADDRESS>or call toll-free at<PHONE_NUMBER>; for

TTY contact<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
 [FR Doc. E7-1910 Filed 2-6-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: May 20, 2010 (Volume 75, Number 97)]
[Notices]
[Page 28257-28260]
[DOCID:fr20my10-5135]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0226]

Draft Guidance for Industry, Third Parties and Food and Drug
Administration Staff; Medical Device ISO 13485:2003 Voluntary Audit
Report Submission Program; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Medical Device ISO
13485:2003 Voluntary Audit Report Submission Program.'' This draft
guidance is intended to provide information on the implementation of a
section of the Food and Drug Administration Amendments Act of 2007
(FDAAA), which amends a section of the Federal Food, Drug, and Cosmetic
Act (the act). This guidance document describes how FDA's Center for
Devices and Radiological Health (CDRH) and Center for Biologics
Evaluation and Research (CBER) are implementing this provision of the
law. 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 on
this draft guidance before it begins work on the final version of the
guidance, submit

written or electronic comments on the draft guidance by August 18,
2010. Submit written or electronic comments on the collection of
information July 19, 2010.

ADDRESSES:  Submit written requests for single copies of the draft
guidance document entitled ``Medical Device ISO 13485:2003 Voluntary
Audit Report Submission Program'' to the Division of Small
Manufacturers, International, and Consumer Assistance (DSMICA), Center
for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, Room 4613, Silver Spring, MD 20993
or to the Office of Communications, Outreach and Development (HFM-40),
Center for Biologics Evaluation and Research, Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. The draft guidance may also be obtained by mail by calling CBER
at 1-800-835-4709 or<PHONE_NUMBER>. Send one self-addressed adhesive
label to assist that office in processing your request, or fax your
request to<PHONE_NUMBER>. See the SUPPLEMENTARY INFORMATION section for
information on electronic access to the guidance.
    Submit written comments concerning this draft guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments to http://www.regulations.gov. Identify comments with the
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Kimberly A. Trautman, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Room 3422, Silver Spring, MD 20993, 301-
796-5515, or Stephen Ripley, Center for Biologics Evaluation and
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft guidance is intended to provide information on the
implementation of section 228 of FDAAA, which amends section 704(g)(7)
of the act (21 U.S.C. 374(g)(7)). Under this draft guidance, device
manufacturers whose establishment has been audited under one of the
regulatory systems implemented by the Global Harmonization Task Force
(GHTF) founding members\1\ using ISO 13485:2003 ``Medical devices--
Quality management systems--Requirements for regulatory purposes,'' may
voluntarily submit the resulting audit report to FDA. If, based on that
report, FDA determines there is minimal probability--in light of the
relationship between the quality system deficiencies observed and the
particular device and manufacturing processes involved--that the
establishment will produce nonconforming and/or defective finished
devices, then FDA intends to use the audit results as part of its risk
assessment to determine whether that establishment can be removed from
FDA's routine work plan for 1 year. The medical device ISO 13485:2003
Voluntary Audit Report Submission Program outlined in this draft
guidance is another way in which FDA may leverage audits performed by
other GHTF regulators and accredited third parties in order to assist
the agency in setting risk-based inspectional priorities.
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    \1\ The GHTF founding members auditing systems include the
Canadian Medical Devices Conformity Assessment System; the European
Union Notified Body accreditation system; the Therapeutics Goods
Administration of Australia Inspectorate; and the Japanese Medical
Device Ministry of Health, Labour and Welfare system.
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    This notice of availability and draft guidance satisfy the public
notice requirement of section 704(g)(7)(F) of the act, which provides
that FDA shall give public notice of the ISO standard(s) under which
FDA accepts voluntary submissions of audit reports.

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 ``Medical
Device ISO 13485:2003 Voluntary Audit Report Submission Program.'' 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 using the Internet. To receive ``Draft Guidance for Industry,
Third Parties and FDA Staff: Medical Device ISO 13485:2003 Voluntary
Audit Report Submission Program'' you may either send an e-mail request
to<EMAIL_ADDRESS>to receive an electronic copy of the document or
send a fax request to<PHONE_NUMBER> to receive a hard copy. Please use
the document number 1705 to identify the guidance you are requesting.
    A search capability for all CDRH guidance documents is available at
http://www.fda.gov/cdrh/guidance.html. Guidance documents are also
available at http://www.regulations.gov or at http://www.fda.gov/
BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/
Guidances/default.htm.

IV. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3520), Federal agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a
60-day notice in the Federal Register concerning each proposed
collection of information before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
    Title: Draft Guidance for Industry, Third Parties and FDA Staff:
Medical Device ISO 13485:2003 Voluntary Audit Report Submission
Program.
    Description: Section 228 of the Food and Drug Administration
Amendments Act of 2007 (FDAAA), amended section 704(g)(7) of the Food,
Drug, and Cosmetic Act (the act) (21 U.S.C. 374(g)(7)) to add the
following provision:
    ``(F) For the purpose of setting risk-based inspectional
priorities, the Secretary shall accept voluntary

submissions of reports of audits assessing conformance with appropriate
quality system standards set by the International Organization for
Standardization (ISO) and identified by the Secretary in public notice.
If the owner or operator of an establishment elects to submit audit
reports under this subparagraph, the owner or operator shall submit all
such audit reports with respect to the establishment during the
preceding 2-year periods.''
    The ``Draft Guidance for Industry, Third Parties and FDA Staff:
Medical Device ISO 13485:2003 Voluntary Audit Report Submission
Program'' will describe how FDA's CDRH and CBER are implementing this
provision of the law and providing public notice as required. The
proposed collections of information are necessary to satisfy the
previously mentioned statutory requirements for implementing this
voluntary submission program.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                            No. of        Annual Frequency     Total Annual       Hours per
 Type of Respondent      Respondents        per Response        Responses         Response        Total Hours
----------------------------------------------------------------------------------------------------------------
Domestic or foreign               1,600                  1              1,600               2              3,200
 device manufacturer
 whose establishment
 was audited under
 ISO 13485:2003
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on FDA's experience with the founding regulatory members of
GHTF, FDA expects that the vast majority of manufacturers who will
participate in the Voluntary Audit Report Submission Program will be
manufacturers who are certified by Health Canada under ISO
13485:2003.\2\ In 2008, approximately 2,650 manufacturers or
manufacturing sites had been certified by Health Canada.
---------------------------------------------------------------------------

    \2\ The majority of these manufacturers are also certified under
ISO 13485:2003 by the European Union Notified Body accreditation
system.
---------------------------------------------------------------------------

    In addition, FDA only expects firms who do not have major
deficiencies or observations in their ISO 13485:2003 audits to be
willing to submit their audit reports to FDA under the Voluntary Audit
Report Submission Program. FDA analyzed its inspection data from Fiscal
Year (FY) 2008 (October 1, 2007 to October 1, 2008) and determined that
the total number of inspections finalized in FY2008 for medical devices
was 1,965. The breakdown for the 1,965 compliance decisions is as
follows:

                                     Table 2.--Compliance Decision Breakdown
----------------------------------------------------------------------------------------------------------------
    Compliance Decision\1\                       Number                           Approximate Percentage
----------------------------------------------------------------------------------------------------------------
Official Action Indicated                                           148                                       8%
----------------------------------------------------------------------------------------------------------------
Voluntary Action Indicated                                          775                                      40%
----------------------------------------------------------------------------------------------------------------
No Action Indicated                                               1,025                                      52%
----------------------------------------------------------------------------------------------------------------
Pending Final Decision                                               17                                       1%
----------------------------------------------------------------------------------------------------------------
\1\ June 15, 2006, Compliance Program 7382.845 Inspection of Medical Device Manufacturers Part V http://
  www.fda.gov/cdrh/comp/guidance/7382.845.html#p5p5.pdf.

    Because FDA only expects firms who do not have major deficiencies
or observations to be willing to submit their audit reports to FDA
under the Voluntary Audit Report Submission Program, FDA only expects
to receive audit reports that would have been classified by FDA as No
Action Indicated (NAI).
    Assuming that the percentage breakdown of compliance decisions for
all inspections conducted in FY2008 can be extrapolated and applied to
audits of manufacturers certified under ISO 13485:2003 by Health
Canada, FDA can estimate the number of Canadian establishments that
would have had an inspection classified as an NAI. Since 52 percent of
all compliance decisions resulted in a NAI decision, FDA estimates that
1,378 of the facilities certified under ISO 13485:2003 by Health Canada
(52 percent of the total 2,650 facilities) would have had an inspection
classified as an NAI. Since FDA only expects to receive audit reports
that would have been classified by FDA as NAI, FDA expects 1,378, or
approximately 1,400, audit reports to be submitted.
    Since FDA expects that the vast majority of manufacturers who will
participate in the Voluntary Audit Report Submission Program will be
manufacturers certified by Health Canada under ISO 13485:2003, FDA
expects the number of reports to be submitted from manufacturers
certified by regulatory systems established by other founding GHTF
members to be minimal. For purposes of calculating the reporting
burden, FDA estimates that approximately 10 percent of total audit
reports submitted under this program will be from these other
manufacturers. Since 90 percent of the audit reports are expected to be
submitted by manufacturers certified by Health Canada (approximately
1,400 audit reports as calculated previously in this document), then
the total number of audit reports FDA expects to receive in a year is
1,556, or approximately 1,600, audit reports.
    FDA further estimates that the gathering, scanning, and submission
of the audit reports, certificates, and related correspondence would
take approximately 2 hours.
    This draft guidance also refers to previously approved collections
of information found in FDA regulations. These collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 820 have been approved

under OMB control number 0910-0073 and the collections of information
for the Inspection by Accredited Persons Program have been approved
under OMB control number 0910-0569.

V. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), written or electronic comments regarding this
document. Submit a single copy of electronic comments or two paper
copies of any mailed comments, except that individuals may submit one
paper copy. Comments are to be identified 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.

    Dated: May 17, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-12098 Filed 5-19-10; 8:45 am]
BILLING CODE 4160-01-S