[Federal Register Volume 82, Number 166 (Tuesday, August 29, 2017)]
[Notices]
[Page 41080]
[FR Doc No: 2017-18350]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a closed meeting on Thursday, August
31, 2017 at 2 p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the closed meeting.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or his designee, has
certified that, in his opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR
200.402(a)(3), (a)(5), (a)(7), (a)(9)(ii) and (a)(10), permit
consideration of the scheduled matters at the closed meeting.
    Commissioner Piwowar, as duty officer, voted to consider the items
listed for the closed meeting in closed session.
    The subject matters of the closed meeting will be:
    Institution and settlement of injunctive actions;
    Institution and settlement of administrative proceedings;
    Adjudicatory matters;
    Resolution of litigation claims; and
    Other matters relating to enforcement proceedings.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed; please contact Brent J. Fields from
the Office of the Secretary at<PHONE_NUMBER>.

    Dated: August 24, 2017.
Brent J. Fields,
Secretary.
[FR Doc. 2017-18350 Filed 8-25-17; 11:15 am]
 BILLING CODE 8011-01-P


IMPORTANT NOTE TO USER:

The margins and lines are NOT block protected, so you must fill the form
with caution, paying attention to any shifting of the existing text.
The following tips should make this a simple task:

       -	Fill in the spaces by using the type over command.  Otherwise
you(ll have to delete a space for each letter you add.

       -	Use the same font (Times New Roman 8pt).

       -	Do not change table lines (although you can delete an extra
space line to provide more space elsewhere.

       -	It is not recommended that you convert this form to WP5.1, some
of these features are not available in WP5.1, so the text will scramble.

If you have any problems or questions, please call your OEI Desk
Officer.

	PAPERWORK REDUCTION ACT SUBMISSION

 tc \l2 "PAPERWORK REDUCTION ACT SUBMISSION

Please read the instructions before completing this form.  For
additional forms or assistance in completing this form, contact your
agency(s Paperwork Clearance Officer.  Send two copies of this form, the
collection instrument to be reviewed, the Supporting Statement and any
additional documentation to: Office of Information and Regulatory
Affairs, Office of Management and Budget, Docket Library, Room 10102,
725 17th Street NW Washington, DC 20503.

1.  Agency/Subagency originating request

EPA

2.  OMB control number                 b. (None

a __ __  __ __ - __ __ __ __               2060-

3.  Type of information collection (check one)

     a. (New collection

     b. ( Revision of a currently approved collection

     c. ( Extension of a currently approved collection

     d. ( Reinstatement, without change, of a previously approved

              collection for which approval has expired

     e. ( Reinstatement, with change, of a previously approved

              collection for which approval has expired

     f. ( Existing collection in use without an OMB control number

4. Type of review requested (check one)

    a. (Regular

    b. ( Emergency - Approval requested by:          /       /

    c. ( Delegated

5.  Small entities

     Will this information collection have a significant economic

      impact on a substantial number of small entities?    ( Yes     (No

    For b-f, note item A2 of Supporting Statement Instructions

6.  Requested expiration date

   a. (Three years from approval date   b.( Other Specify:      /
/___

7.  Title

Information on Exposure to n-Propyl Bromide under the Significant New
Alternatives Policy (SNAP) Program

8. Agency form number(s) (If applicable)

#2224.01

9. Keywords

Significant New Alternatives Policy (SNAP) Program, ozone depleting
substances (ODS), Clean Air Act

10. Abstract

The proposed rule takes comment on an option requiring monitoring of
exposure levels of the chemical n-propyl bromide with minimal
record-keeping to demonstrate compliance with the health-based exposure
limit.  No reporting would be required.  By keeping this information,
end users would be able to demonstrate compliance with the use condition
in the case of an inspection by EPA.

Primary responders would be businesses that use n-propyl bromide as a
cleaning solvent, an aerosol solvent, or a carrier solvent in adhesives.

11.  Affected public (Mark primary with (P( and all others that apply
with (X()

a.     Individuals or households   d.      Farms

b. P  Business or other for-profit e.  X    Federal Government

c.     Not-for-profit institutions   f.      State, Local or Tribal
Government

12. Obligation to respond (Mark primary with (P( and all others that
apply with (X()

        a.  ( Voluntary

        b.  ( Required to obtain or retain benefits

        c.  P( Mandatory

13.  Annual reporting and recordkeeping hour burden

       a. Number of respondents                 Up to 4910

        b. Total annual responses                 Up to 120,100

            1. Percentage of these responses

                     collected electronically                 0
             %

        c.  Total hours requested                    24,050

        d.  Current OMB inventory                       0

        e.  Difference

        f.  Explanation of difference

             1.  Program Change                       X

             2.  Adjustment

14. Annual reporting and recordkeeping cost burden (in thousands of
dollars)

       a.  Total annualized capital/startup costs                $0

        b. Total annual costs (O&M)
$11,545

        c. Total annualized cost requested                         $
11,545

        d. Current OMB inventory                                      0

        e. Difference
     $  11,545

        f. Explanation of difference

            1.  Program change
       X

            2.  Adjustment

15. Purpose of  information collection (Mark Primary With (P( and all
others that apply with (X()

  a. __Application for benefits     e. __Program planning or management

  b. __Program evaluation            f. __Research

  c. __General purpose statistics   g. P_Regulatory  or  compliance

  d. __Audit

16. Frequency of recordkeeping or reporting (check all that apply)

      a. (Recordkeeping                        b. ( Third party
disclosure

      c. ( Reporting

              1. ( On occasion        2. ( Weekly                   3. (
Monthly

              4. ( Quarterly               5. ( Semi-annually        6.
( Annually

              7. ( Biannually              8. ( Other (describe)

17.  Statistical methods

       Does this information collection employ statistical methods?

                                                        ( Yes        (
No

18.  Agency contact (person who can best answer questions regarding the
content of this submission)

        Name:       Margaret Sheppard

        Phone:<PHONE_NUMBER>

OMB 83-I 	10/95

19.  Certification for Paperwork Reduction Act Submissions

On behalf of this Federal agency, 1 certify that the collection of
information encompassed by this request complies with'

5 CFR 1320.9.

NOTE: 	The text of  5 CFR 1320.9,  and the related provisions of 5 CFR
1320.8(b)(3), appear at the end of the instructions.  The certification
is to be made with reference to those regulatory provisions as set forth
 in the instructions.

The following is a summary of the topics, regarding the proposed
collection of information, that the certification covers:

(a)  It is necessary for the proper performance of agency functions;

(b)  It avoids unnecessary duplication;

(c)  It reduces burden on small entities;

(d)  It uses plain, coherent, and unambiguous terminology that is
understandable to respondents;

(e)  Its implementation will be consistent and compatible with current
reporting and recordkeeping practices;

(f)  It indicates the retention periods for recordkeeping requirements;

(g)  It informs respondents of the information called for under 5 CFR
1320.8(b)(3):

(I)  Why the information is being collected(

(ii)  Use of information;

(iii)  Burden estimate;

(iv)  Nature of response (voluntary, required for a benefit, or
mandatory);

(v)   Nature and extent of confidentiality; and

(vi)  Need to display currently valid OMB control number;

(h)  It was developed by an office that has planned and allocated
resources for the efficient and effective management

                          and use of the information to be collected
(see note in Item 19 of the instructions);

(I)  It uses effective and efficient statistical survey methodology; and

(j)  It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions,
identify the item below and explain the reason in Item 18 of the
Supporting Statement.

Signature of Program Official	Drusilla Hufford, Director

	Stratospheric Protection Division

	 Office of Air and Radiation

Date

Signature of Senior Official or designee	Oscar Morales, Director

	Collection Strategies  Division

	Office of Environmental Information

Date

OMB 83-I 	10/95

	Certification Requirement for Paperwork Reduction Act Submissions

 tc \l2 "	Certification Requirement for Paperwork Reduction Act
Submissions

5 CFR 1320.9 reads (As part of the agency submission to OMB of a
proposed collection of information, the agency (through the head of the
agency, the Senior Official or their designee) shall certify (and
provide a record supporting such certification) that the proposed
collection of information --

     ((a) is necessary for the proper performance of the functions of
the agency, including that the information to be collected will have
practical utility;

     ((b) is not unnecessarily duplicative of information otherwise
reasonably accessible to the agency;

     ((c) reduces to the extent practicable and appropriate the burden
on persons who shall provide information to or for the agency, including
with respect to small entities, as defined in the Regulatory Flexibility
Act 5 U.S.C ( 601(6)), the use of such techniques as:

((1) establishing differing compliance or reporting requirements or
timetables that take into account the resources available to those who
are to respond;

((2) the clarification, consolidation, or simplification of compliance
and reporting requirements; or collection of information , or any part
thereof;

((3) an exemption from coverage of the collection of information, or any
part thereof;

      ((d) is written using plain, coherent, and unambiguous terminology
and is understandable to those who are to respond;

      ((e) is to be implemented in ways consistent and compatible, to
the maximum extent practicable, with the existing reporting and
recordkeeping practices of those who are to respond;

       ((f) indicates for each recordkeeping requirement the length of
time persons are required to maintain the records specified;

       ((g) informs potential respondents of the information called for
under ( 1320.8(b)(3); [see below]

       ((h) has been developed by an office that has planned and
allocated resources for the efficient and effective management and use
of the information to be collected, including the processing of  the
information in a manner  which shall enhance, where appropriate, the
utility of the information to agencies and the public;

       ((I)  uses effective and efficient statistical survey methodology
appropriate to the purpose for which the information is to be collected;
and

       ((j) to the maximum extent practicable, uses appropriate
information technology to reduce burden and improve data quality, agency
efficiency and responsiveness to the public.(

NOTE: 5 CFR 1320.8(b)(3) requires that each collection of information:

        ((3) informs and provides reasonable notice to the potential
persons to whom the collection of information is addressed of:

((I) the reasons the information is planned to be and/or has been used
to further the proper performance of the functions of  the agency;

((ii) the way such information is planned to be and/or has been used to
further the proper performance of  the functions of the agency;

((iii) an estimate, to the extent practicable, of  the average burden of
 the collection (together  with a request that the public direct to the
agency any comments concerning the accuracy of  this burden estimate and
any suggestions for reducing this burden);

((iv) whether responses to the collection of information are voluntary,
required to obtain or retain a benefit (citing authority), or mandatory
(citing authority);

((v) the nature and extent of confidentiality to be provided, if any
(citing authority); and

((vi) the fact that any 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 OMB control number.(

OMB 83-I (Instructions)

                                                10/95


[Federal Register: May 28, 2010 (Volume 75, Number 103)]
[Notices]
[Page 30017-30018]
[DOCID:fr28my10-71]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM01-5-000]

Electronic Tariff Filings; Notice of Posting Regarding Filing
Procedures for Electronically Filed Tariffs

May 21, 2010.
    Take Notice that the attached document ``Filing Procedures For
Electronically Filed Tariffs, Rate Schedules And Jurisdictional
Agreements'' has been posted on the eTariff Web site (http://
www.ferc.gov/docs-filing/etariff.asp) under Commission Orders and
Notices at http://www.ferc.gov/docs-filing/etariff/com-order.asp.
    For further information, please contact Keith Pierce at 202-502-
8525 or Andre Goodson at<PHONE_NUMBER>, or through e-mail to
<EMAIL_ADDRESS>
Kimberly D. Bose,
Secretary.

Filing Procedures for Electronically Filed Tariffs, Rate Schedules and
Jurisdictional Agreements

    In Order No. 714,\1\ the Commission adopted regulations requiring
that, starting April 1, 2010, and for a transition period through
September 30, 2010, all tariffs, rate schedules, and jurisdictional
agreements, and revisions to such documents, filed with the Commission
must be filed electronically according to a format provided in the
Implementation Guide.\2\ Based on issues that have arisen on some of
the baseline tariff filings, and inquiries, this notice describes
procedures for making electronic tariff filings.\3\ Electronic tariff
filings that do not comply with these requirements are subject to
rejection.
---------------------------------------------------------------------------

    \1\ Electronic Tariff Filings, Order No. 714, FERC Stats. &
Regs. ] 31,276 (2008).
    \2\ The data elements and communication protocol are described
in the Implementation Guide for Electronic Filing of Parts 35, 154,
284, 300, and 341 Tariff Filing (Implementation Guide), available at
http://www.ferc.gov/docs-filing/etariff/implementation-guide.pdf.
    \3\ As indicated in Order No. 714, this phrase is intended to
encompass rate schedule and jurisdictional agreement filings as
well. Order No. 714, at P 13 n.11.
---------------------------------------------------------------------------

     Once a Baseline Tariff Filing Has Been Made, All Tariff
Filings Must be Made Electronically Pursuant to the Order No. 714
Guidelines.
    Once a company makes its baseline tariff filing in compliance with
Order No. 714, the company must make all subsequent filings of tariffs,
rate schedules, and jurisdictional agreements in the Order No. 714
baseline tariff filing format. As provided in Order No. 714, this
requirement is not limited to tariffs or to modifications of the
baseline tariff filing, but encompasses all the company's other
tariffs, rate schedules, and jurisdictional agreements, and all filings
revising, withdrawing, or otherwise affecting such documents or the
effective dates of such provisions. For example, natural gas negotiated
rate agreements and non-conforming service agreements, electric rate
schedules, transmission, power sale, and ancillary service agreements,
interconnection agreements, and all other jurisdictional agreements are
covered by this requirement. As described below, this requirement also
applies to tariff filings related to periods earlier than the baseline
filing. Once the Office of the Secretary accepts a company's baseline
tariff filing for processing, the company should not make any further
tariff related filings on paper or electronically in a format that does
not comply with the electronic filing format required by Order No. 714.
     Required Tariff Documents To Be Included With an
Electronic Tariff Filing.
    As part of an electronic tariff filing, companies must include as
tariff records 1) a copy of the proposed tariff provision, and 2) the
plain text of the tariff provision. In addition as attachments,
companies must include 3) a clean copy of the tariff provision and 4)
the marked text of the provision (when required).
     Electronic Tariff Filings for Periods Earlier Than the
Baseline Filing.
    The electronic tariff software will not accept electronic tariff
filings with tariff records that have a proposed effective date earlier
than the effective date associated with the tariff identification
number for the baseline filing. Companies may have outstanding
compliance obligations or rates for prior, locked-in periods that need
to be filed with the Commission or may need to propose changes to parts
of a company's tariffs that were not part of the baseline tariff
filing. Such filings should be made in the following manner:
     [cir] The compliance or other provision applicable to the period
after the baseline tariff filing has been accepted by the Secretary for
processing must be made in the electronic tariff filing format required
by Order No. 714.
     [cir] Tariff provisions governing periods earlier than the
baseline filing must be included either as part of the transmittal
letter or as a separate attachment, unless the company and its
customers have waived the need to file tariff provisions for the
earlier periods.

    As an example, if a company with a baseline tariff effective April
15, 2010, has an outstanding compliance filing with an effective date
of January 1, 2010, that the Commission accepts, the company must file
the compliance tariff provisions as tariff records in accordance with
the electronic file format of Order No. 714 with an effective date of
April 15, 2010. The company also should file the tariff provisions with
a January 1, 2010, effective date either as part of the transmittal
letter or as a separate attachment.
     FASTR Requirements for Natural Gas Pipelines.
    FASTR will be retired after the baseline tariff filings have been
made and the current FASTR configuration for each company as of
September 30, 2010, will be added to the Commission's database as
historical records. Once a baseline tariff filing has been made,
pipelines are no longer required to submit records in FASTR format.
However, companies that wish to update their FASTR records for past
periods may submit an electronic version in the FASTR ASCII file format
as an attachment.

[FR Doc. 2010-12860 Filed 5-27-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 58 (Wednesday, March 25, 2020)]
[Notices]
[Pages 16935-16936]
[FR Doc No: 2020-06232]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP19-502-000]

Commonwealth LNG, LLC; Notice Suspending Environmental Review
Schedule

    The Federal Energy Regulatory Commission (FERC or Commission) is
suspending the environmental review schedule for Commonwealth LNG,
LLC's (Commonwealth) proposed liquefied natural gas (LNG) export
terminal in Cameron Parish, Louisiana. The notice of schedule, issued
on October 15, 2019, identified a May 2020 draft Environmental Impact
Statement (EIS) issuance date and an October 2, 2020 final EIS issuance
date. This schedule was based upon Commonwealth providing complete and
timely responses to any data requests. In its February 4, 2020 partial
response to staff's January 2, 2020 data request, Commonwealth stated
it would provide the remainder of the outstanding responses in stages
through July 2020, including an official interpretation from the United
States Department of Transportation--Pipeline and Hazardous Material
Safety Administration (PHMSA) in June 2020 pertaining to Commonwealth's
proposed LNG storage tank design.
    Because the outstanding data responses to staff's data request and
the issuance of the PHMSA interpretation are expected after the
previously announced draft EIS date, the Commission will suspend the
environmental review schedule for the project. Once staff has reviewed
both the responses and the PHMSA interpretation, the Commission will
issue a revised schedule for the draft and final EIS. This is not a
suspension of the Commission staff's review of Commonwealth's project.
Staff will continue to process Commonwealth's proposal to the extent
possible based upon the information Commonwealth has filed to date
while awaiting the responses and the PHMSA interpretation.

Additional Information

    In order to receive notification of the issuance of the EIS and to
keep track of all formal issuances and submittals in specific dockets,
the Commission offers a free service called eSubscription. This can
reduce the amount of time you spend researching proceedings by
automatically providing you with notification of these filings,
document summaries, and direct links to the documents. Go to
www.ferc.gov/docs-filing/esubscription.asp.
    Additional information about the Project is available from the
Commission's Office of External Affairs at (866) 208-FERC or on the
FERC website (www.ferc.gov). Using the ``eLibrary'' link, select
``General Search'' from the eLibrary menu, enter the selected date
range and ``Docket Number'' excluding the last three digits (i.e.,
CP19-502), and follow the instructions. For assistance with access to
eLibrary, the helpline can be reached at<PHONE_NUMBER>, TTY (202) 502-
8659, or at<EMAIL_ADDRESS>The eLibrary link on the FERC
website also provides access to the texts of formal documents issued by
the Commission, such as orders, notices, and rule makings.

    Dated: March 16, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-06232 Filed 3-24-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 138 (Monday, July 20, 2015)]
[Notices]
[Pages 42797-42798]
[FR Doc No: 2015-17694]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #2

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER11-3576-012; ER11-3401-011.
    Applicants: Golden Spread Electric Cooperative, Inc., Golden Spread
Panhandle Wind Ranch, LLC.
    Description: Notice of Non-material Change in Status of Golden
Spread Electric Cooperative, Inc.
    Filed Date: 7/13/15
    Accession Number: 20150713-5221.
    Comments Due: 5 p.m. ET 8/3/15.

    Docket Numbers: ER13-1947-001.
    Applicants: PJM Interconnection, L.L.C.
    Description: Compliance filing: Designation of Filing Party assoc
to Compliance Filing in Docket No. ER13-1947 to be effective N/A.
    Filed Date: 7/14/15.
    Accession Number: 20150714-5095.
    Comments Due: 5 p.m. ET 8/4/15.

    Docket Numbers: ER15-1196-003.
    Applicants: Nevada Power Company, Sierra Pacific Power Company.
    Description: Compliance Filing with no tariff revisions of Nevada
Power Company, et al.
    Filed Date: 7/13/15.
    Accession Number: 20150713-5227.
    Comments Due: 5 p.m. ET 8/3/15.

    Docket Numbers: ER15-2200-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Compliance filing: Compliance Filing per 5/14/2015
Order in Docket No. ER13-1947-000 to be effective 1/1/2014.
    Filed Date: 7/14/15.
    Accession Number: 20150714-5087.
    Comments Due: 5 p.m. ET 8/4/15.

    Docket Numbers: ER15-2201-000.
    Applicants: Alabama Power Company.
    Description: Section 205(d) Rate Filing: Wheeler Solar (McRae
Solar) SGIA Filing to be effective 6/29/2015.
    Filed Date: 7/14/15.
    Accession Number: 20150714-5107.
    Comments Due: 5 p.m. ET 8/4/15.

    Docket Numbers: ER15-2202-000.
    Applicants: Alabama Power Company.
    Description: Section 205(d) Rate Filing: Wheeler Solar (Wheeler
Solar) SGIA Filing to be effective 6/29/2015.
    Filed Date: 7/14/15.
    Accession Number: 20150714-5108.
    Comments Due: 5 p.m. ET 8/4/15.

    Docket Numbers: ER15-2203-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Section 205(d) Rate Filing: 2015-07-14_SA 2819
Certificate of Concurrence ComEd-Ameren TIA to be effective 7/13/2015.
    Filed Date: 7/14/15.
    Accession Number: 20150714-5127.
    Comments Due: 5 p.m. ET 8/4/15.

    Docket Numbers: ER15-2204-000.
    Applicants: California Independent System Operator Corporation.
    Description: Section 205(d) Rate Filing: 2015-07-14 Pricing
Enhancements--ETC-TOR Self-Schedules to be effective 9/15/2015.
    Filed Date: 7/14/15.
    Accession Number: 20150714-5135.
    Comments Due: 5 p.m. ET 8/4/15.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: July 14, 2015.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2015-17694 Filed 7-17-15; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: August 25, 2009 (Volume 74, Number 163)]
[Rules and Regulations]
[Page 42773-42775]
[DOCID:fr25au09-3]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2009-N-0344]

Microbiology Devices; Reclassification of Herpes Simplex Virus
Types 1 and 2 Serological Assays

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule.

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SUMMARY: The Food and Drug Administration (FDA) is implementing a
direct final rule correcting the regulation classifying herpes simplex
virus (HSV) serological assays by removing the reference to HSV
serological assays other than type 1 and type 2. When reclassifying
this device, FDA mistakenly distinguished between HSV serological
assays type 1 and type 2 and all other HSV serological assays. At that
time, and today, the only preamendments HSV serological assays which
FDA was aware of were type 1 and type 2 and, therefore, the
classification of HSV assays other than type 1 and type 2 was
incorrect. FDA is correcting the classification of this device to
eliminate possible confusion resulting from this error. Elsewhere in
this issue of the Federal Register, we are publishing a companion
proposed rule under FDA's usual procedure for notice and comment to
provide a procedural framework to finalize the rule in the event we
receive significant adverse comment and withdraw this direct final
rule.

DATES:  This rule is effective December 7, 2009. Submit written or
electronic comments on the direct final rule by October 8, 2009. If we
receive no significant adverse comments within the specified comment
period, we intend to publish a document confirming the effective date
of the final rule in the Federal Register within 30 days after the
comment period on this direct final rule ends. If we receive any timely
significant adverse comment, we will withdraw this final rule in part
or in whole by publication of a document in the Federal Register within
30 days after the comment period ends.

ADDRESSES:  You may submit comments, identified by Docket No FDA-2009-
N-0344, by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
    Submit written submissions in the following ways:
     Fax:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer
accepting comments submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic comments by using the Federal
eRulemaking Portal, as described previously, in the ADDRESSES portion
of this document under Electronic Submissions.
    Instructions: All submissions received must include the agency name
and Docket No(s). and Regulatory Information Number (RIN) (if a RIN
number has been assigned) for this rulemaking. All comments received
may be posted without change to http://www.regulations.gov, including
any personal information provided. For additional information on
submitting comments, see the ``Comments'' heading of the SUPPLEMENTARY
INFORMATION section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number(s), found in brackets in the heading of this document,
into the ``Search'' box and follow the prompts and/or go to the
Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.

FOR FURTHER INFORMATION CONTACT: Scott McFarland, Center for Devices
and Radiological Health WO/66, rm. 5543, Food and Drug Administration,
10903 New Hampshire Ave., Silver Spring, MD,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. What Is the Background of the Rule?

    The Federal Food, Drug, and Cosmetic Act (the act), as amended by
the Medical Device Amendments of 1976 (the 1976 amendments) (Public Law
94-295), the Safe Medical Devices Act of 1990 (SMDA) (Public Law 101-
629), the Food and Drug Modernization Act of 1997 (FDAMA) (Public Law
105-115), and the Food and Drug Administration Amendments Act of 2007
(FDAAA) (Public Law 110-85), among other amendments, established a
comprehensive system for the regulation of medical devices intended for
human use. Section 513 of the act (21 U.S.C. 360c) established three
categories (classes) of devices, depending on the regulatory controls
needed to provide reasonable assurance of their safety and
effectiveness. The three categories of devices are class I (general
controls), class II (special controls), and class III (premarket
approval).
    Devices that were in commercial distribution before May 28, 1976
(the date of enactment of the 1976 amendments), are commonly referred
to as ``preamendments devices.'' Under section 513 of the act, FDA
classifies preamendments devices according to the following steps: (1)
FDA receives a recommendation from a device classification panel (an
FDA advisory committee); (2) FDA publishes the panel's recommendation
for comment, along with a proposed regulation classifying the device;
and (3) FDA publishes a final regulation classifying the device. FDA
has classified most preamendments devices under these procedures.
    Devices that were not in commercial distribution before May 28,
1976, are commonly referred to as ``postamendments devices.'' These
devices are classified automatically by statute (section 513(f) of the
act (21 U.S.C. 360c(f)) into class III and require premarket approval,
unless and until: (1) FDA reclassifies the device into class I or II;
(2) FDA issues an order classifying the device into class I or II in
accordance with section 513(f)(2) of the act; or (3) FDA issues an
order under section 513(i) of the act (21 U.S.C. 360c(i)) finding the
device to be substantially equivalent to a predicate device that does
not require premarket approval.
    In the Federal Register of November 9, 1983 (47 FR 50823), FDA
classified the preamendments devices, herpes simplex virus serological
reagents, into class III (Sec.  866.3305 (21 CFR 866.3305)). At the
time FDA classified the device, the only preamendments HSV serological
assays FDA was aware of were type 1 and type 2 HSV serological assays.
Since that time, FDA has not become aware of any other preamendments
HSV serological assays, nor has it received a premarket notification
for a HSV serological assay other than a type 1 or type 2 HSV
serological assay.
    In the Federal Register of April 3, 2007 (72 FR 15828), FDA
published a final rule reclassifying the preamendments device HSV
serological assays from class III to class II. In that rulemaking FDA
identified the device being reclassified as type 1 and type 2 HSV
serological assays and identified other HSV serological assays as class
III devices. However, as stated previously, the only preamendments HSV
serological assays of which FDA is aware are type 1 and type 2 HSV
serological assays. To avoid any possible confusion, FDA is correcting
the regulation to accurately describe this generic type of device. This
direct final rule corrects the classification regulation by removing
the reference to HSV serological assays other than type 1 and type 2.

II. What Does This Direct Final Rulemaking Do?

    In this direct final rule, FDA is correcting Sec.  866.3305 by
removing from the regulation the reference to HSV serological assays
other than type 1 and type 2.

III. What Are the Procedures for Issuing a Direct Final Rule?

    In the Federal Register of November 21, 1997 (62 FR 62466), FDA
announced the availability of the guidance document entitled ``Guidance
for FDA and Industry: Direct Final Rule Procedures'' that described
when and how FDA will employ direct final rulemaking. We believe that
this rule is appropriate for direct final rulemaking because it is
intended to make noncontroversial changes to existing regulations. We
anticipate no significant adverse comment. Consistent with FDA's
procedures on direct final rulemaking, we are publishing elsewhere in
this issue of the Federal Register a companion proposed rule that is
identical to the direct final rule. The companion proposed rule
provides a procedural framework within which the rule may be finalized
in the event the direct final rule is withdrawn because of any
significant adverse comment. The comment period for this direct final
rule runs concurrently with the comment period of the companion
proposed rule. Any comments received in response to the companion
proposed rule will also be considered as comments regarding this direct
final rule.
    We are providing a comment period on the direct final rule of 75
days after the date of publication in the Federal Register. If we
receive any significant adverse comment, we intend to withdraw this
final rule before its effective date by publication of a notice in the
Federal Register within 30 days after the comment period ends. A
significant adverse comment is defined as a comment that explains why
the rule would be inappropriate, including challenges to the rule's
underlying premise or approach, or would be ineffective or unacceptable
without change. In determining whether an adverse comment is
significant and warrants withdrawing a direct final rulemaking, we will
consider whether the comment raises an issue serious enough to warrant
a substantive response in a notice-and-comment process in accordance
with section 553 of the Administrative Procedure Act (APA) (5 U.S.C.
553). Comments that are frivolous, insubstantial, or outside the scope
of the rule will not be considered significant or adverse under this
procedure. For example, a comment recommending an additional change to
the rule will not be considered a significant adverse comment, unless
the comment states why the rule would be ineffective without the
additional change. In addition, if a significant adverse comment
applies to part of a rule and that part can be severed from the
remainder of the rule, we may adopt as final those parts of the rule
that are not the subject of a significant adverse comment. If we
withdraw the direct final rule, all comments received will be
considered under the companion proposed rule in developing a final rule
under the usual notice-and-comment procedures under the APA (5 U.S.C.
552a et seq.). If we receive no significant adverse comment during the
specified comment period, we intend to publish a confirmation document
in the Federal Register within 30 days after the comment period ends.

IV. What is the Legal Authority for This Rule?

    FDA is issuing this direct final rule under the device and general
administrative provisions of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321, 331, 351, 352, 360i, 371, and 374).

V. What is the Environmental Impact of This Rule?

    FDA has determined under 21 CFR 25.30(i) and 25.34(b) that this
action is of a type that does not individually or cumulatively have a
significant effect on

the human environment. Therefore, neither an environmental assessment
nor an environmental impact statement is required.

VI. What is the Economic Impact of This Rule?

    FDA has examined the impacts of the direct final rule under
Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-
612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4).
Executive Order 12866 directs agencies to assess all costs and benefits
of available regulatory alternatives and, when regulation is necessary,
to select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this direct final rule is not a significant regulatory action under the
Executive order.
    The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because we do not believe any companies are
currently selling or producing these devices, the agency certifies that
the final rule will not have a significant economic impact on a
substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $133 million, using the most current (2008) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.

VII. How Does the Paperwork Reduction Act of 1995 Apply to This Rule?

    This direct final rule contains no collection of information.
Therefore, clearance by the Office of Management and Budget under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) is not required.

VIII. What are the Federalism Impacts of This Rule?

    FDA has analyzed this direct final rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the rule does not contain policies that have substantial direct effects
on the States, on the relationship between the National Government and
the States, or on the distribution of power and responsibilities among
the various levels of government. Accordingly, the agency has concluded
that the rule does not contain policies that have federalism
implications as defined in the Executive order and, consequently, a
federalism summary impact statement is not required.

IX. How Do You Submit Comments on This Rule?

    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.

List of Subjects in 21 CFR Part 866

    Biologics, Laboratories, and Medical devices.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed to amend 21 CFR part 866 as follows:

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

0
1. The authority citation for 21 CFR part 866 continues to read as
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Section 866.3305 is amended by removing paragraph (c) and by
revising paragraph (b) to read as follows:

Sec.  866.3305  Herpes simplex virus serological assays.

* * * * *
    (b) Classification. Class II (special controls). The device is
classified as class II (special controls). The special control for the
device is FDA's guidance document entitled ``Class II Special Controls
Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological
Assays.'' For availability of the guidance document, see Sec.
866.1(e).

    Dated: August 17, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-20411 Filed 8-24-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register: August 22, 2007 (Volume 72, Number 162)]
[Notices]
[Page 47017-47023]
[DOCID:fr22au07-102]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2007- 2007-0361; FRL-8143-8]

Pesticide Emergency Exemptions; Agency Decisions and State and
Federal Agency Crisis Declarations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: EPA has granted or denied emergency exemptions under the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for use of
pesticides as listed in this notice. The exemptions or denials were
granted during the period April 1 to June 30, 2007 to control
unforeseen pest outbreaks.

FOR FURTHER INFORMATION CONTACT: See each emergency exemption or denial
for the name of a contact person. The following information applies to
all contact persons: Team Leader, Emergency Response Team, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: EPA has granted or denied emergency
exemptions to the following State and Federal agencies. The emergency
exemptions may take the following form: Crisis, public health,
quarantine,

or specific. EPA has also listed denied emergency exemption requests in
this notice.

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions discussed above. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established a docket for this action under
docket identification (ID) number EPA-HQ-OPP-2007-0361. Publicly
available docket materials are available either electronically at
http://www.regulations.gov, or, if only available in hard copy, at the

OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of
this Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The Docket Facility telephone number
is<PHONE_NUMBER>.
    2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr.

II. Background

    Under FIFRA section 18, EPA can authorize the use of a pesticide
when emergency conditions exist. Authorizations (commonly called
emergency exemptions) are granted to State and Federal agencies and are
of four types:
    1. A ``specific exemption'' authorizes use of a pesticide against
specific pests on a limited acreage in a particular State. Most
emergency exemptions are specific exemptions.
    2. ``Quarantine'' and ``public health'' exemptions are a particular
form of specific exemption issued for quarantine or public health
purposes. These are rarely requested.
    3. A ``crisis exemption'' is initiated by a State or Federal agency
(and is confirmed by EPA) when there is insufficient time to request
and obtain EPA permission for use of a pesticide in an emergency.
    EPA may deny an emergency exemption: If the State or Federal agency
cannot demonstrate that an emergency exists, if the use poses
unacceptable risks to the environment, or if EPA cannot reach a
conclusion that the proposed pesticide use is likely to result in ``a
reasonable certainty of no harm'' to human health, including exposure
of residues of the pesticide to infants and children.
    If the emergency use of the pesticide on a food or feed commodity
would result in pesticide chemical residues, EPA establishes a time-
limited tolerance meeting the ``reasonable certainty of no harm
standard'' of the Federal Food, Drug, and Cosmetic Act (FFDCA).
    In this document: EPA identifies the State or Federal agency
granted the exemption or denial, the type of exemption, the pesticide
authorized and the pests, the crop or use for which authorized, number
of acres (if applicable), and the duration of the exemption. EPA also
gives the Federal Register citation for the time-limited tolerance, if
any.

III. Emergency Exemptions and Denials

A. U. S. States and Territories

Alabama

Department of Agriculture and Industries

Specific Exemption: EPA authorized the use of diuron in catfish ponds
to control blue-green algae (Oscillatoria chalybea (cyanobacteria));
April 16, 2007 to April 16, 2008. Contact: (Libby Pemberton).
Quarantine Exemption: EPA authorized the use of flusilazole on soybeans
to control Australasian soybean rust (Phakopsora pachyrhizi); June 15,
2007 to June 15, 2010. Contact: (Andrea Conrath).
    EPA authorized the use of cyproconazole on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); May 4, 2007 to March
31, 2009. Contact: (Stacey Groce).
    EPA authorized the use of metconazole on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); June 15, 2007 to
April 19, 2007. Contact: (Stacey Groce).
    EPA authorized the use of flutriafol on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); May 11, 2007 to May
11, 2010. Contact: (Princess Campbell).

Arkansas

State Plant Board

Specific Exemption: EPA authorized the use of diuron in catfish ponds
to control blue-green algae (Oscillatoria chalybea (cyanobacteria));
April 16, 2007 to April 16, 2008. Contact: (Libby Pemberton).
    EPA authorized the use of sulfosulfuron on bermudagrass and
bahiagrass pastures and hayfields to control Johnsongrass (Sorghum
halepense); May 29, 2007 to September 15, 2007. Contact: (Libby
Pemberton).
    EPA authorized the use of fenpyroximate in beehives to control
varroa mites; June 15, 2007 to February 28, 2008. Contact: (Stacey
Groce).
Crisis: On April 20, 2007, for the use of metribuzin on corn to control
freeze damaged corn. This program ended on May 5, 2007. Contact:
(Marcel Howard).
    On May 15, 2007, for the use of thifensulfuron on wheat to control
frost damaged wheat. This program ended on May 29, 2007. Contact:
(Marcel Howard).
Quarantine Exemption: EPA authorized the use of flusilazole on soybeans
to control Australasian soybean rust (Phakopsora pachyrhizi); June 15,
2007 to June 15, 2010. Contact: (Andrea Conrath).
    EPA authorized the use of metconazole on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); June 15, 2007 to
April 19, 2009. Contact: (Stacey Groce).

California

Environmental Protection Agency, Department of Pesticide Regulation

Specific Exemption: EPA authorized the use of oxytetracycline on Pink
Lady apples to control fire blight; March 16, 2007 to August 1, 2007.
Contact: (Andrew Ertman).
    EPA authorized the use of fenamidone on carrots to control cavity
spot; June 30, 2007 to June 30, 2008. Contact: (Andrea Conrath).
    EPA authorized the use of myclobutanil on bell and non-bell peppers
to control powdery mildew; June 1, 2007 to May 31, 2008. Contact:
(Stacey Groce).

Crisis: On March 16, 2007, for the use of oxytetracycline on Pink Lady
apples to control fire blight. This program ended on August 1, 2007.
Contact: (Andrew Ertman).
Quarantine: EPA authorized the use of diflubenzuron on commercial,
institutional, and residential plantings of trees, shrubs (including
containerized nursery stock), citrus fruits, avocados, subtropical and
tropical fruits that have been quarantined to treat diaprepes root
weevil; April 20, 2007 to April 14, 2010. Contact: (Libby Pemberton).

Colorado

Department of Agriculture

Specific Exemption: EPA authorized the use of formetanate hydrochloride
on onion, bulb to control thrips; May 16, 2007 to September 30, 2007.
Contact: (Andrew Ertman).
    EPA authorized the use of abamectin on onion, bulb to control
thrips; June 25, 2007 to September 30, 2007. Contact: (Andrew Ertman).
    EPA authorized the use of fenpyroximate in beehives to control
varroa mites; May 4, 2007 to February 28, 2008. Contact: (Stacey
Groce).

Delaware

Department of Agriculture

Quarantine Exemption: EPA authorized the use of flusilazole on soybeans
to control Australasian soybean rust (Phakopsora pachyrhizi); June 15,
2007 to June 15, 2010. Contact: (Andrea Conrath).
    EPA authorized the use of cyproconazole on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); May 4, 2007 to March
31, 2009. Contact: (Stacey Groce).
    EPA authorized the use of metconazole on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); June 15, 2007 to
April 19, 2009. Contact: (Stacey Groce).
    EPA authorized the use of flutriafol on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); June 7, 2007 to June
7, 2010. Contact: (Princess Campbell).

Georgia

Department of Agriculture

Quarantine Exemption: EPA authorized the use of flusilazole on soybeans
to control Australasian soybean rust (Phakopsora pachyrhizi); July 6,
2007 to June 15, 2010. Contact: (Andrea Conrath).
    EPA authorized the use of flutriafol on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); May 11, 2007 to May
11, 2010. Contact: (Princess Campbell).

Idaho

Department of Agriculture

Specific Exemption: EPA authorized the use of lambda cyhalothin on
barley to control Russian wheat aphids, cereal leaf beetles, cutworms,
and armyworms; May 1, 2007 to August 15, 2007. Contact: (Andrew
Ertman).
    EPA authorized the use of formetanate hydrochloride on onion, bulb
to control thrips; May 15, 2007 to September 15, 2007. Contact: (Andrew
Ertman).

Illinois

Department of Agriculture

Specific Exemption: EPA authorized the use of tebuconazole on wheat to
control Fusarium head blight (FHB); April 13, 2007 to June 20, 2007.
Contact: (Libby Pemberton).
Crisis: On May 18, 2007, for the use of thifensulfuron on wheat to
control frost damaged wheat. This program ended on June 1, 2007.
Contact: (Marcel Howard).
Quarantine Exemption: EPA authorized the use of flusilazole on soybeans
to control Australasian soybean rust (Phakopsora pachyrhizi); June 15,
2007 to June 15, 2010. Contact: (Andrea Conrath).
    EPA authorized the use of metconazole on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); June 15, 2007 to
April 19, 2009. Contact: (Stacey Groce).
    EPA authorized the use of flutriafol on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); May 11, 2007 to May
11, 2010. Contact: (Princess Campbell).

Indiana

Office of Indiana State Chemist

Specific Exemption: EPA authorized the use of tebuconazole on wheat to
control Fusarium head blight (FHB); May 2, 2007 to June 30, 2007.
Contact: (Libby Pemberton).
Crisis: On May 12, 2007, for the use of clethodim on corn to control
burndown frost damaged corn. This program ended on May 26, 2007.
Contact: (Marcel Howard)
Quarantine Exemption:EPA authorized the use of flusilazole on soybeans
to control Australasian soybean rust (Phakopsora pachyrhizi); June 15,
2007 to June 15, 2010. Contact: (Andrea Conrath).
    EPA authorized the use of myclobutanil on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi; May 4, 2007 to May
31, 2009. Contact: (Stacey Groce).
    EPA authorized the use of cyproconazole on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); May 4, 2007 to March
31, 2009. Contact: (Stacey Groce).
    EPA authorized the use of metconazole on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); June 15, 2007 to
April 19, 2009. Contact: (Stacey Groce).

Iowa

Department of Agriculture and Land Stewardship

Specific Exemption: EPA authorized the use of sulfentrazone on
strawberries to control broadleaf weeds; June 25, 2007 to December 15,
2007. Contact: (Andrew Ertman).
    Quarantine Exemption:EPA authorized the use of flusilazole on
soybeans to control Australasian soybean rust (Phakopsora pachyrhizi);
June 15, 2007 to June 15, 2010. Contact: (Andrea Conrath).
    EPA authorized the use of metconazole on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); June 15, 2007 to
April 19, 2009. Contact: (Stacey Groce).

Kansas

Department of Agriculture

Specific Exemption: EPA authorized the use of mesotrione on sorghum to
control broadleaf weeds; April 24, 2007 to June 15, 2007. Contact:
(Andrew Ertman).
    EPA authorized the use of coumaphos in beehives to control varroa
mites and small hive beetles; April 13, 2007 to February 1, 2008.
Contact: (Stacey Groce).
Quarantine Exemption: EPA authorized the use of flusilazole on soybeans
to control Australasian soybean rust (Phakopsora pachyrhizi); June 15,
2007 to June 15, 2010. Contact: (Andrea Conrath).
    EPA authorized the use of cyproconazole on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); May 4, 2007 to March
31, 2009. Contact: (Stacey Groce).
    EPA authorized the use of metconazole on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); June 15, 2007 to
April 19, 2009. Contact: (Stacey Groce).

Kentucky

Department of Agriculture

Crisis: On May 7, 2007, for the use of thifensulfuron on wheat to
control frost damaged wheat. This program ended on May 22, 2007.
Contact: (Marcel Howard).
Quarantine Exemption:EPA authorized the use of flusilazole on soybeans
to control Australasian soybean rust (Phakopsora pachyrhizi); June 15,
2007 to June 15, 2010. Contact: (Andrea Conrath).

    EPA authorized the use of cyproconazole on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); May 4, 2007 to March
31, 2009. Contact: (Stacey Groce).
    EPA authorized the use of metconazole on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); June 15, 2007 to
April 19, 2009. Contact: (Stacey Groce).

Louisiana

Department of Agriculture and Forestry

Quarantine Exemption:EPA authorized the use of flusilazole on soybeans
to control Australasian soybean rust (Phakopsora pachyrhizi); June 15,
2007 to June 15, 2010. Contact: (Andrea Conrath).
    EPA authorized the use of cyproconazole on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); May 4, 2007 to March
31, 2009. Contact: (Stacey Groce).
    EPA authorized the use of metconazole on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); June 15, 2007 to
April 19, 2009. Contact: (Stacey Groce).
    EPA authorized the use of flutriafol on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); June 7, 2007 to June
7, 2010. Contact: (Princess Campbell).

Maryland

Department of Agriculture

Quarantine Exemption: EPA authorized the use of flusilazole on soybeans
to control Australasian soybean rust (Phakopsora pachyrhizi); June 15,
2007 to June 15, 2010. Contact: (Andrea Conrath).
    EPA authorized the use of metconazole on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); June 15, 2007 to
April 19, 2009. Contact: (Stacey Groce).
    EPA authorized the use of flutriafol on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); May 11, 2007 to May
11, 2010. Contact: (Princess Campbell).

Massachusetts

Massachusetts Department of Food and Agriculture

Specific Exemption:EPA authorized the use of coumaphos in beehives to
control varroa mites and small hive beetles; May 17, 2007 to February
1, 2008. Contact: (Stacey Groce).
    EPA authorized the use of pronamide on cranberry to control dodder;
April 24, 2007 to June 30, 2007. Contact: (Marcel Howard).

Michigan

Michigan Department of Agriculture

Specific Exemption: EPA authorized the use of tebuconazole on wheat to
control Fusarium head blight (FHB); April 13, 2007 to June 25, 2007.
Contact: (Libby Pemberton).
    EPA authorized the use of mancozeb on ginseng to control alternaria
stem and leaf blight; April 19, 2007 to October 31, 2007. Contact:
(Stacey Groce).
    EPA authorized the use of formetanate hydrochloride on onion, bulb
to control thrips; July 15, 2007 to August 31, 2007. Contact: (Andrew
Ertman).
Quarantine Exemption:EPA authorized the use of flusilazole on soybeans
to control Australasian soybean rust (Phakopsora pachyrhizi); June 15,
2007 to June 15, 2010. Contact: (Andrea Conrath).
    EPA authorized the use of cyproconazole on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); May 4, 2007 to March
31, 2009. Contact: (Stacey Groce).
    EPA authorized the use of metconazole on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); June 15, 2007 to
April 19, 2009. Contact: (Stacey Groce).

Minnesota

Department of Agriculture

Specific Exemption:EPA authorized the use of tebuconazole on barley and
wheat to control Fusarium head blight (FHB); May 2, 2007 to September
1, 2007. Contact: (Libby Pemberton).

Mississippi

Department of Agriculture and Commerce

Specific Exemption:EPA authorized the use of diuron in catfish ponds to
control blue-green algae (Oscillatoria chalybea (cyanobacteria)); April
16, 2007 to April 16, 2008. Contact: (Libby Pemberton).
    EPA authorized the use of fenpyroximate in beehives to control
varroa mites; June 15, 2007 to February 28, 2008. Contact: (Stacey
Groce).
Crisis: On April 24, 2007, for the use of clethodim on corn to control
freeze damaged corn. This program ended on May 8, 2007. Contact:
(Marcel Howard).
Quarantine Exemption:EPA authorized the use of flusilazole on soybeans
to control Australasian soybean rust (Phakopsora pachyrhizi); June 15,
2007 to June 15, 2010. Contact: (Andrea Conrath).
    EPA authorized the use of cyproconazole on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); May 4, 2007 to March
31, 2009. Contact: (Stacey Groce).
    EPA authorized the use of metconazole on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); June 15, 2007 to
April 19, 2009. Contact: (Stacey Groce).
    EPA authorized the use of flutriafol on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); May 11, 2007 to May
11, 2010. Contact: (Princess Campbell).

Missouri

Department of Agriculture

Quarantine Exemption: EPA authorized the use of flusilazole on soybeans
to control Australasian soybean rust (Phakopsora pachyrhizi); June 15,
2007 to June 15, 2010. Contact: (Andrea Conrath).
    EPA authorized the use of metconazole on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); June 15, 2007 to
April 19, 2009. Contact: (Stacey Groce).
Specific Exemption: EPA authorized the use of fenpyroximate in beehives
to control varroa mites; June 8, 2007 to February 28, 2008. Contact:
(Stacey Groce).

Montana

Department of Agriculture

Specific Exemption:EPA authorized the use of lambda cyhalothrin on
barley to control Russian wheat aphid, cereal leaf beetle, armyworms,
and cutworms; April 19, 2007 to July 30, 2007. Contact: (Andrew
Ertman).
    EPA authorized the use of tebuconazole on barley and wheat to
control Fusarium head blight (FHB); May 15, 2007 to July 20, 2007.
Contact: (Libby Pemberton).

Nebraska

Department of Agriculture

Specific Exemption:EPA authorized the use of mesotrione on sorghum to
control broadleaf weeds; April 24, 2007 to June 15, 2007. Contact:
(Andrew Ertman).
    Quarantine Exemption:EPA authorized the use of flusilazole on
soybeans to control Australasian soybean rust (Phakopsora pachyrhizi);
June 15, 2007 to June 15, 2010. Contact: (Andrea Conrath).
    EPA authorized the use of metconazole on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); June 15, 2007 to
April 19, 2009. Contact: (Stacey Groce).

New Jersey

Department of Environmental Protection

Specific Exemption:EPA authorized the use of coumaphos in beehives to
control varroa mites and small hive beetles; April 13, 2007 to February
1, 2008. Contact: (Stacey Groce).
    EPA authorized the use of pronamide on cranberry to control dodder;
April

27, 2007 to December 15, 2007. Contact: (Marcel Howard).

New Mexico

Department of Agriculture

Specific Exemption: EPA authorized the use of mylcobutanil on chile
(non-bell) peppers to control powdery mildew; June 28, 2007 to October
15, 2007. Contact: (Stacey Groce).

New York

Department of Environmental Conservation

Specific Exemption: EPA authorized the use of desmedipham on garden
(red table) beet to control several important broadleaf weeds,
including hairy galinsoga, common ragweed, redroot pigweed, common
lambsquarters, velvetleaf, nightshade spp. and wild mustard; May 8,
2007 to August 15, 2007. Contact: (Libby Pemberton).
    EPA authorized the use of formetanate hydrochloride on onion, bulb
to control thrips; July 15, 2007 to September 15, 2007. Contact:
(Andrew Ertman).
Quarantine: EPA authorized the use of cyproconazole on soybeans to
control Australasian soybean rust (Phakopsora pachyrhizi); May 4, 2007
to March 31, 2009. Contact: (Stacey Groce).
    EPA authorized the use of metconazole on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); June 15, 2007 to
April 19, 2009. Contact: (Stacey Groce).

North Carolina

Department of Agriculture and Consumer Services

Crisis: On May 30, 2007, for the use of thifensulfuron on wheat to
control frost damaged wheat. This program ended on June 13, 2007.
Contact: (Marcel Howard).
Quarantine Exemption:EPA authorized the use of flusilazole on soybeans
to control Australasian soybean rust (Phakopsora pachyrhizi); June 15,
2007 to June 15, 2010. Contact: (Andrea Conrath).
    EPA authorized the use of cyproconazole on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); May 4, 2007 to March
31, 2009. Contact: (Stacey Groce).
    EPA authorized the use of metconazole on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); June 15, 2007 to
April 19, 2009. Contact: (Stacey Groce).
    EPA authorized the use of flutriafol on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); June 7, 2007 to June
7, 2010. Contact: (Princess Campbell).

North Dakota

Department of Agriculture

Specific Exemption:EPA authorized the use of tebuconazole on barley and
wheat to control Fusarium head blight (FHB); April 13, 2007 to
September 1, 2007. Contact: (Libby Pemberton).
    EPA authorized the use of zeta-cypermethrin on flax to control
grasshoppers; May 15, 2007 to September 30, 2007. Contact: (Andrew
Ertman).
Quarantine Exemption:EPA authorized the use of flusilazole on soybeans
to control Australasian soybean rust (Phakopsora pachyrhizi); June 15,
2007 to June 15, 2010. Contact: (Andrea Conrath).
    EPA authorized the use of cyproconazole on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); May 4, 2007 to March
31, 2009. Contact: (Stacey Groce).
    EPA authorized the use of metconazole on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); June 15, 2007 to
April 19, 2009. Contact: (Stacey Groce).
    EPA authorized the use of flutriafol on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); May 11, 2007 to May
11, 2010. Contact: (Princess Campbell).

Ohio

Department of Agriculture

Specific Exemption:EPA authorized the use of formetanate hydrochloride
on onion, bulb to control thrips; July 1, 2007 to September 15, 2007.
Contact: (Andrew Ertman).
Quarantine Exemption:EPA authorized the use of flusilazole on soybeans
to control Australasian soybean rust (Phakopsora pachyrhizi); June 15,
2007 to June 15, 2010. Contact: (Andrea Conrath).
    EPA authorized the use of cyproconazole on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); May 4, 2007 to March
31, 2009. Contact: (Stacey Groce).
    EPA authorized the use of metconazole on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); June 15, 2007 to
April 19, 2007. Contact: (Stacey Groce).
    EPA authorized the use of flutriafol on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); May 11, 2007 to May
11, 2010. Contact: (Princess Campbell).
Crisis: On May 9, 2007, for the use of clethodim on corn to control
burndown frost damaged corn. This program ended on June 15, 2007.
Contact: (Marcel Howard).

Oklahoma

Department of Agriculture

Specific Exemption:EPA authorized the use of sulfosulfuron on
bermudagrass pastures and hayfields to control Johnsongrass (Sorghum
halepense); May 11, 2007 to September 30, 2007. Contact: (Libby
Pemberton).
    EPA authorized the use of fenpyroximate in beehives to control
varroa mites; June 15, 2007 to February 28, 2008. Contact: (Stacey
Groce).
Quarantine Exemption:EPA authorized the use of flusilazole on soybeans
to control Australasian soybean rust (Phakopsora pachyrhizi); June 15,
2007 to June 15, 2010. Contact: (Andrea Conrath).
    EPA authorized the use of cyproconazole on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); May 4, 2007 to March
31, 2009. Contact: (Stacey Groce).
    EPA authorized the use of metconazole on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); June 15, 2007 to
April 19, 2009. Contact: (Stacey Groce).

Oregon

Department of Agriculture

Specific Exemption:EPA authorized the use of formetanate hydrochloride
on onion, bulb to control thrips; May 15, 2007 to September 15, 2007.
Contact: (Andrew Ertman).
    EPA authorized the use of fenamidone on carrots to control cavity
spot; May 2, 2007 to November 1, 2007. Contact: (Andrea Conrath).
    EPA authorized the use of bifenthrin on orchardgrass grown for seed
to control Banks grass mite; April 10, 2007 to November 15, 2007.
Contact: (Andrea Conrath).
    EPA authorized the use of dimethenamid on winter squash to control
nightshade and other summer annual weeds; April 2, 2007 to August 1,
2007. Contact: (Marcel Howard).
    EPA authorized the use of fipronil on turnip and rutabaga to
control the cabbage maggot; May 4, 2007 to September 30, 2007. Contact:
(Andrea Conrath).

Rhode Island

Department of Environmental Management

Specific Exemption:EPA authorized the use of pronamide on cranberry to
control dodder; April 24, 2007 to June 30, 2007. Contact: (Marcel
Howard).

South Carolina

Clemson University

Quarantine: EPA authorized the use of flutriafol on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); June 28, 2007 to
June 28, 2010. Contact: (Princess Campbell).

Department of Pesticide Regulation and Public Services at Clemson
University

Specific Exemption:EPA authorized the use of coumaphos in beehives to
control varroa mites and small hive beetles; April 3, 2007 to February
1, 2008. Contact: (Stacey Groce).
Quarantine Exemption:EPA authorized the use of flusilazole on soybeans
to control Australasian soybean rust (Phakopsora pachyrhizi); July 6,
2007 to June 15, 2010. Contact: (Andrea Conrath).
    EPA authorized the use of cyproconazole on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi; May 4, 2007 to March
31, 2009. Contact: (Stacey Groce).
    EPA authorized the use of flutriafol on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); June 28, 2007 to
June 28, 2010. Contact: (Princess Campbell).

South Dakota

Department of Agriculture

Specific Exemption:EPA authorized the use of tebuconazole on barley and
wheat to control Fusarium head blight (FHB); April 13, 2007 to
September 1, 2007. Contact: (Libby Pemberton).
    EPA authorized the use of coumaphos in beehives to control varroa
mites and small hive beetles; April 13, 2007 to February 1, 2008.
Contact: (Stacey Groce).
    EPA authorized the use of fenpyroximate in beehives to control
varroa mites; May 4, 2007 to February 28, 2008. Contact: (Stacey
Groce).
Quarantine: EPA authorized the use of chlorophene in laboratories to
control prions; May 1, 2007 to May 1, 2010. Contact: (Princess
Campbell).

Tennessee

Department of Agriculture

Crisis: On April 30, 2007, for the use of clethodim on corn to control
freeze damaged corn. This program ended on May 13, 2007. Contact:
(Marcel Howard).
    On May 1, 2007, for the use of thifensulfuron on wheat to control
frost damaged wheat. This program ended on June 1, 2007. Contact:
(Marcel Howard).
Quarantine Exemption:EPA authorized the use of flusilazole on soybeans
to control Australasian soybean rust (Phakopsora pachyrhizi); June 15,
2007 to June 15, 2010. Contact: (Andrea Conrath).
    EPA authorized the use of cyproconazole on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi; May 4, 2007 to March
31, 2009. Contact: (Stacey Groce).
    EPA authorized the use of metconazole on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); June 15, 2007 to
April 19, 2009. Contact: (Stacey Groce).

Texas

Department of Agriculture

Specific Exemption:EPA authorized the use of diuron in catfish and bass
ponds to control blue-green algae (Oscillatoria chalybea
(cyanobacteria)); April 4, 2007 to April 4, 2008. Contact: (Libby
Pemberton).
    EPA authorized the use of fenpyroximate in beehives to control
varroa mites; June 15, 2007 to February 28, 2008. Contact: (Stacey
Groce).
    EPA authorized the use of hexythiazox on field corn to control the
Banks grass mite and two-spotted spider mite; June 1, 2007 to August
31, 2007. Contact: ((Andrew Ertman)).
    EPA authorized the use of formetanate hydrochloride on onion, bulb
to control thrips; January 9, 2007 to May 31, 2007. Contact: (Andrew
Ertman).
    EPA authorized the use of sulfosulfuron on bermudagrass pastures
and hayfields to control Johnsongrass (Sorghum halepense)); June 14,
2007 to June 30, 2008. Contact: (Libby Pemberton).
Crisis: On January 9, 2007, for the use of formetanate hydrochloride on
onion, bulb to control thrips. This program ended on May 31, 2007.
Contact: (Andrew Ertman).
    On April 25, 2007, for the use of zeta-cypermethrin on citrus
fruits to control citrus root weevil (Diaprepes abbreviatus). This
program is expected to end on October 31, 2007. Contact: (Libby
Pemberton).
    On May 7, 2007, for the use of etofenprox on rice to control rice
water weevil (Lissorhoptrus oryzophilus). This program ended on July 1,
2007. Contact: (Libby Pemberton).
Quarantine Exemption:EPA authorized the use of flusilazole on soybeans
to control Australasian soybean rust (Phakopsora pachyrhizi); June 15,
2007 to June 15, 2010. Contact: (Andrea Conrath).
    EPA authorized the use of cyproconazole on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); May 4, 2007 to March
31, 2009. Contact: (Stacey Groce).
    EPA authorized the use of flutriafol on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); June 7, 2007 to June
7, 2010. Contact: (Princess Campbell).
    EPA authorized the use of metconazole on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); June 15, 2007 to
April 19, 2009. Contact: (Stacey Groce).

Virginia

Department of Agriculture and Consumer Services

Quarantine Exemption:EPA authorized the use of flusilazole on soybeans
to control Australasian soybean rust (Phakopsora pachyrhizi); June 15,
2007 to June 15, 2010. Contact: (Andrea Conrath).
    EPA authorized the use of cyproconazole on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); May 4, 2007 to March
31, 2009. Contact: (Stacey Groce).
    EPA authorized the use of metconazole on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); June 15, 2007 to
April 19, 2009. Contact: (Stacey Groce).
    EPA authorized the use of flutriafol on soybeans to control
Australasian soybean rust (Phakopsora pachyrhizi); June 28, 2007 to
June 28, 2010. Contact: (Princess Campbell).

Washington

Department of Agriculture

Specific Exemptions:EPA authorized the use of formetanate hydrochloride
on onion, bulb to control thrips; May 15, 2007 to August 30, 2007.
Contact: (Andrew Ertman)
    EPA authorized the use of fenamidone on carrots to control cavity
spot; May 2, 2007 to November 1, 2007. Contact: (Andrea Conrath).

West Virginia

Department of Agriculture

Specific Exemption:EPA authorized the use of coumaphos in beehives to
control varroa mites and small hive beetles; April 24, 2007 to February
1, 2008. Contact: (Stacey Groce).

Wisconsin

Department of Agriculture, Trade, and Consumer Protection

Specific Exemption:EPA authorized the use of mesotrione on cranberry to
control birdsfoot trefoil (Lotus corniculatus), violet (Viola spp.),
marsh St. John's wort (Triadenum Raf.), and buttercup (Ranunculus
spp.); April 23, 2007 to September 30, 2007. Contact: (Libby
Pemberton).
    EPA authorized the use of formetanate hydrochloride on onion, bulb
to control thrips; June 1, 2007 to September 15, 2007. Contact: (Andrew
Ertman)
    EPA authorized the use of fenpyroximate in beehives to control
varroa mites; June 15, 2007 to February 28, 2008. Contact: (Stacey
Groce).

Wyoming

Department of Agriculture

Specific Exemption: EPA authorized the use of lambda cyhalothrin on
barley to control the Russian wheat aphid, cereal leaf beetle, army
cutworms, and pale western cutworms; April 19, 2007 to July 31, 2007.
Contact: (Andrew Ertman).
    EPA authorized the use of coumaphos in beehives to control varroa
mites and small hive beetles; April 24, 2007 to February 1, 2008.
Contact: (Stacey Groce).
Quarantine: EPA authorized the use of chlorophene in laboratories to
control prions; April 4, 2007 to April 4, 2010. Contact: (Princess
Campbell).

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: August 9, 2007.
Donald R. Stubbs,
Acting Director, Registration Division, Office of Pesticide Programs.
[FR Doc. E7-16312 Filed 8-21-07; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 86, Number 175 (Tuesday, September 14, 2021)]
[Notices]
[Pages 51219-51220]
[FR Doc No: 2021-19803]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2008-0362]

Medical Review Board (MRB); Notice of Meeting

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of meeting.

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

SUMMARY: This notice announces a meeting of the Medical Review Board
Advisory Committee (MRB), which will take place via videoconference.

DATES: The meeting will be held on Wednesday, September 29, 2021, from
1:00 to 5:00 p.m., Eastern Time (ET). The meeting will be open to the
public for its entirety. Advance registration is recommended via the
FMCSA website at www.fmcsa.dot.gov/mrb. Requests for accommodations
because of a disability must be received by September 16, 2021.
Requests to submit written materials to be reviewed during the meeting
must be received no later than September 20, 2021. Please register to
attend the meeting by September 20, 2021.

ADDRESSES: The meeting will be held via videoconference. To indicate
that you will attend, please register at www.fmcsa.dot.gov/mrb. Those
members of the public who would like to participate should go to
https://www.fmcsa.dot.gov/advisory-committees/mrb/meetings to access
the meeting, task statements, a detailed agenda for the entire meeting,
meeting minutes and additional information on the committee and its
activities. The meeting will be recorded, and a link to the recording
will be posted on the FMCSA website.

FOR FURTHER INFORMATION CONTACT: Ms. Shannon L. Watson, Senior Advisor
to the Associate Administrator for Policy, Federal Motor Carrier Safety
Administration, U.S. Department of Transportation, 1200 New Jersey
Avenue SE, Washington, DC 20590, (202) 3660-2925<EMAIL_ADDRESS>Any
committee-related request should be sent to the person listed in this
section.

SUPPLEMENTARY INFORMATION:

I. Background

    The MRB was created under the Federal Advisory Committee Act
(FACA), in accordance with section 4116 of the Safe, Accountable,
Flexible, Efficient Transportation Equity Act: A Legacy for Users,
SAFETEA-LU, Public Law 109-59 (2005) (codified as amended at 49 U.S.C.
31149), to provide

advice to FMCSA on ``medical standards for operators of commercial
motor vehicles that will ensure that the physical condition of
operators of commercial motor vehicles is adequate to enable them to
operate the vehicles safely.'' The MRB operates in accordance with FACA
under the terms of the MRB charter, filed November 25, 2019.

II. Agenda

    At the meeting, the agenda will cover MRB's consideration of the
U.S. Food and Drug Administration's June 30, 2021 announcement
regarding the voluntary recall of certain Continuous Positive Air
Pressure (CPAP) machines due to potential health risks. FMCSA will task
the MRB with providing recommendations about how to best assist medical
examiners on the National Registry of Certified Medical Examiners
(National Registry) and the commercial motor vehicle (CMV) drivers who
use these CPAPs on identifying reliable sources of information
concerning options for drivers with machines covered by the recall.

III. Meeting Participation

    Although not required, advance registration is encouraged. To
indicate that you will attend, please register at the website listed in
the ADDRESSES section by the deadline referenced in the DATES section.
The meeting will be open to the public for its entirety.
    The U.S. Department of Transportation is committed to providing
equal access to this meeting for all participants. If you need
alternative formats or services because of a disability, such as sign
language, interpretation, or other ancillary aids, please contact the
person listed in the FOR FURTHER INFORMATION CONTACT section.
    Verbal comments from the public will be heard throughout the
meeting, at the discretion of the MRB chairman and designated federal
officer. These statements may be limited in duration to ensure that all
who wish to comment may do so. Members of the public may submit written
comments to the person listed in the FOR FURTHER INFORMATION CONTACT
section on the topics to be considered during the meeting by the
deadline referenced in the DATES section. Any member of the public may
submit a written statement after the meeting deadline, and it will be
presented to the committee.

Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2021-19803 Filed 9-13-21; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 81, Number 162 (Monday, August 22, 2016)]
[Notices]
[Pages 56656-56658]
[FR Doc No: 2016-19939]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-2473]

Adapting Regulatory Oversight of Next Generation Sequencing-Based
Tests; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
following public workshop entitled ``Adapting Regulatory Oversight of
Next Generation Sequencing-Based Tests.'' The purpose of this workshop
is to obtain feedback on two FDA draft guidances, ``Use of Standards in
FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In
Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases'' and
``Use of Public Human Genetic Variant Databases to Support Clinical
Validity for Next Generation Sequencing (NGS)-Based In Vitro
Diagnostics'' that describes new approaches to regulate NGS-based
tests.

DATES: The public workshop will be held on September 23, 2016, from 9
a.m.to 3 p.m. Submit either electronic or written comments on the
public workshop by October 6, 2016.

ADDRESSES: The workshop will be held in Masur Auditorium at the NIH
Campus, 9000 Rockville Pike, Bldg. 10, Bethesda, MD 20814. For parking
and security information, please refer to the NIH Campus Visitor
Information: http://www.nih.gov/icd/od/ocpl/VIC/index.htm.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2016-N-2473 for ``Adapting Regulatory Oversight of Next Generation
Sequencing-Based Tests.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at http://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The

second copy, which will have the claimed confidential information
redacted/blacked out, will be available for public viewing and posted
on http://www.regulations.gov. Submit both copies to the Division of
Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: David Litwack, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4548, Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In Vitro diagnostic devices that utilize NGS technology to generate
information on an individual's genome are rapidly transforming
healthcare. As part of the Precision Medicine Initiative,\1\ FDA is
developing and implementing a novel framework for NGS test regulation
that can accelerate innovation while assuring NGS-based test safety and
effectiveness. To advance this effort, FDA published two draft
guidances on July 8, 2016. The first, entitled ``Use of Public Human
Genetic Variant Databases to Support Clinical Validity for Next
Generation Sequencing (NGS)-Based In Vitro Diagnostics'', describes how
publicly accessible databases of human genetic variants can serve as
sources of valid scientific evidence to support the clinical validity
of genotype-phenotype relationships in FDA's regulatory review of NGS-
based tests. This draft guidance further outlines the process by which
administrators of genetic variant databases could voluntarily apply to
FDA for recognition, and how FDA would review such applications and
periodically reevaluate recognized databases.
---------------------------------------------------------------------------

    \1\ The Precision Medicine Initiative found on the White House's
Web site at: https://www.whitehouse.gov/precision-medicine.
---------------------------------------------------------------------------

    The second draft guidance document, entitled ``Use of Standards in
the Food and Drug Administration's Regulatory Oversight of Next
Generation Sequencing-Based In Vitro Diagnostics Used for Diagnosing
Germline Diseases'', addresses DNA sequencing and whole exome
sequencing NGS-based tests intended to aid in the diagnosis of
individuals with suspected germline diseases or other conditions. This
document provides recommendations for designing, developing, and
validating NGS-based tests for germline diseases, and also discusses
possible use of FDA-recognized standards for regulatory oversight of
these tests. These recommendations are based on FDA's understanding of
the tools and processes needed to run an NGS-based test along with the
design and analytical validation considerations appropriate for such
tests.
    Neither draft guidance is final nor in effect at this time. The
workshop announced in this document seeks to obtain public input on the
proposals contained in the two draft guidances. Workshop material,
including the draft guidances, can be accessed from the workshop Web
site: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the
posted events list).

II. Topics for Discussion at the Public Workshop

    This public workshop will consist of presentations that will frame
the goals of the workshop followed by moderated discussions via panel
sessions. The presentations and discussions will focus on the content
of the draft guidances, as well as on additional questions that were
posed in the Notices of Availability published in the Federal Register
on July 8, 2016. These notices can be found at https://federalregister.gov/a/2016-1233 and https://federalregister.gov/a/2016-1270.
    Registration: Registration is free and available on a first-come,
first-served basis. Persons interested in attending this public
workshop must register online by September 13, 2016, at 4 p.m. Early
registration is recommended because facilities are limited and,
therefore, FDA may limit the number of participants from each
organization. If time and space permits, onsite registration on the day
of the public workshop will be provided beginning at 8 a.m.
    If you need special accommodations due to a disability, please
contact Susan Monahan,<PHONE_NUMBER><EMAIL_ADDRESS>no
later than September 12, 2016.
    To register for the public workshop, please visit FDA's Medical
Devices News, Events, Workshops, and Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm.
(Select this public workshop from the posted events list.) Please
provide complete contact information for each attendee, including name,
title, affiliation, address, email, and telephone number. Those without
Internet access should contact David Litwack to register (see FOR
FURTHER INFORMATION CONTACT). Registrants will receive confirmation
after they have been accepted. You will be notified if you are on a
waiting list.
    Streaming Webcast of the Public Workshop: This public workshop will
also be Webcast. The Webcast link will be available on the registration
Web site after September 13, 2016. To view the registration Web site,
please visit FDA's Medical Devices News, Events, Workshops, and
Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. Select this public workshop from the
posted events list. FDA has verified the Web site addresses in this
document, as of the date this document publishes in the Federal
Register, but Web sites are subject to change over time.
    Requests for Oral Presentations: This public workshop includes a
public comment session. During online registration you may indicate if
you wish to present during a public comment session, and which topics
you wish to address. In addition to the subjects discussed in the two
draft guidances, FDA has posed supplemental topics in the Notices of
Availability for the draft guidances (see Supplementary Information).
FDA will do its best to accommodate requests to make public comments.
Individuals and organizations with common interests are urged to
consolidate or coordinate their comments, and request time for joint
comments, or submit requests for designated representatives to
participate in the focused sessions. Following the close of
registration, FDA will determine the amount of time allotted to each
presenter and the approximate time each oral presentation is to begin,

and will select and notify participants by September 14, 2016. All
requests to make oral presentations must be received by September 13,
2016. If selected for presentation, any presentation materials must be
emailed to David Litwack (see FOR FURTHER INFORMATION CONTACT) no later
than September 16, 2016, at 5 p.m. No commercial or promotional
material will be permitted to be presented or distributed at the public
workshop.
    FDA is holding this public workshop to obtain feedback on its
recently released draft guidance documents: ``Use of Public Human
Genetic Variant Databases to Support Clinical Validity for Next
Generation Sequencing-Based In Vitro Diagnostics'' and ``Use of
Standards in the Food and Drug Administration's Regulatory Oversight of
Next Generation Sequencing-Based In Vitro Diagnostics Used for
Diagnosing Germline Diseases''. In order to permit the widest possible
opportunity to obtain public comment, FDA is soliciting either
electronic or written comments on all aspects of the public workshop
topics. The deadline for submitting comments related to this public
workshop is October 6, 2016.
    Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at http://www.regulations.gov. It may
be viewed at the Division of Dockets Management (see ADDRESSES). A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. A transcript will
also be available in either hardcopy or on CD-ROM, after submission of
a Freedom of Information request. The Freedom of Information office
address is available on the Agency's Web site at http://www.fda.gov. A
link to the transcripts will also be available approximately 45 days
after the public workshop on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select
this public workshop from the posted events list.)

    Dated: August 17, 2016.
Peter Lurie,
Associate Commissioner for Public Health Strategy and Analysis.
[FR Doc. 2016-19939 Filed 8-19-16; 8:45 am]
 BILLING CODE 4164-01-P