[Federal Register: June 15, 2007 (Volume 72, Number 115)]
[Notices]
[Page 33271-33272]
[DOCID:fr15jn07-103]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55891; File No. SR-Phlx-2007-39]

Self-Regulatory Organizations; Philadelphia Stock Exchange, Inc.;
Notice of Filing and Immediate Effectiveness of a Proposed Rule Change
Relating to Its Payment for Order Flow Pilot Program

June 11, 2007.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on May 18, 2007, the Philadelphia Stock Exchange, Inc. (``Phlx'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been substantially prepared by the
Exchange. Phlx has designated this proposal as one establishing or
changing a due, fee, or other charge imposed by Phlx under Section
19(b)(3)(A)(ii) of the Act \3\ and Rule 19b-4(f)(2) thereunder,\4\
which renders the proposal effective upon filing with the Commission.
The Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Phlx proposes to extend its payment for order flow pilot
program, which is currently in effect until May 27, 2007, for an
additional one-year period until May 27, 2008. This proposal is
scheduled to expire on the same date as the one-year pilot program in
effect in connection with the provisions of Exchange Rule 1080(l)
relating to Directed Orders.\5\
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    \5\ The provisions of Phlx Rule 1080(l) are in effect for a one-
year pilot period. The Exchange filed a separate proposed rule
change to extend the Rule 1080(l) one-year pilot program for an
additional year until May 27, 2008. See Securities Exchange Release
No. 55803 (May 23, 2007), 72 FR 30413 (May 31, 2007) (SR-Phlx-2007-
37).
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    Other than extending the date of the pilot program for an
additional year, no other changes to the Exchange's current payment for
order flow program are being proposed at this time.
    The Exchange is also proposing to make minor clarifying changes to
the Exchange's Summary of Equity Option and RUT and RMN Charges fee
schedule to update the language that appears in a footnote and to
clarify the title relating to the Exchange's payment for order flow
fees.
    Below is the text of the proposed rule change. Proposed deletions
are in [brackets]; proposed additions are italicized.
Summary of Equity Option Charges (p. 3/6)
* * * * *
[EQUITY OPTION] PAYMENT FOR ORDER FLOW FEES*
    (1) For trades resulting from either Directed or non-Directed
Orders that are delivered electronically and executed on the Exchange:
Assessed on ROTs, specialists and Directed ROTs on those trades when
the specialist unit or Directed ROT elects to participate in the
payment for order flow program. * * *
    (2) No payment for order flow fees will be assessed on trades that
are not delivered electronically.

QQQQ and options that are trading in the Penny Pilot Program--$0.25 per
contract
Remaining Equity Options--$0.70 per contract

    See Appendix A for additional fees.
    *Assessed on transactions resulting from customer orders and are
available to be disbursed by the Exchange according to the instructions
of the specialist units/specialists or Directed ROTs to order flow
providers who are members or member organizations, who submit, as
agent, customer orders to the Exchange or non-members or non-member
organizations who submit, as agent, customer orders to the Exchange
through a member or member organization who is acting as agent for
those customer orders. The [is proposal] payment for order flow fees
[will be in effect for trades settling on or after October 1, 2005 and]
will remain in effect as a pilot program that is scheduled to expire on
May 27, 200[7]8.
    ***Any excess payment for order flow funds billed but not utilized
by the specialist or Directed ROT will be carried forward unless the
Directed ROT or specialist elects to have those funds rebated to the
applicable ROT, Directed ROT or specialist on a pro rata basis,
reflected as a credit on the monthly invoices. At the end of each
calendar quarter, the Exchange will calculate the amount of excess
funds from the previous quarter and subsequently rebate excess funds on
a pro-rata basis to the applicable ROT, Directed ROT or specialist who
paid into that pool of funds.
* * * * *

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

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

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

1. Purpose
    The Exchange states that the purpose of extending the Exchange's
payment for order flow program for an additional year is to remain
competitive with other options exchanges that administer payment for
order flow programs.\6\
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    \6\ See e.g., Securities Exchange Act Release Nos. 53969 (June
9, 2006), 71 FR 34973 (June 16, 2006) (SR-CBOE-2006-53); 55265
(February 9, 2007), 72 FR 7697 (February 16, 2007) (SR-CBOE-2007-
11); 55271 (February 12, 2007), 72 FR 7699 (February 16, 2007) (SR-
ISE-2007-08); and 54152 (July 14, 2006), 71 FR 41488 (July 21, 2006)
(SR-ISE-2006-36).
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    Currently, the following payment for order flow fees are in effect
at the Exchange: \7\ (1) Equity options (other than those options that
trade as part of

the Exchange's Penny Pilot Program) \8\ and options on the Russell
2000[supreg] Index \9\ traded under the symbol RUT and options on the
one-tenth value Russell 2000[supreg] Index traded under the symbol RMN,
are all assessed $0.70 per contract; and (2) options that trade as part
of the Exchange's Penny Pilot Program are assessed $0.25 per contract.
Trades resulting from either Directed or non-Directed Orders that are
delivered electronically over AUTOM \10\ and executed on the Exchange
are assessed a payment for order flow fee,\11\ while non-
electronically-delivered orders (i.e., represented by a floor broker)
are not assessed a payment for order flow fee.\12\
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    \7\ See Securities Exchange Act Release Nos. 53841 (May 19,
2006), 71 FR 30461 (May 26, 2006) (SR-Phlx-2006-33); 54297 (August
9, 2006), 71 FR 47280 (August 16, 2006) (SR-Phlx-2006-47); 54485
(September 22, 2006), 71 FR 57017 (September 28, 2006) (SR-Phlx-
2006-56); 55290 (February 13, 2007), 72 FR 8051 (February 22, 2007)
(SR-Phlx-2007-05); and 55473 (March 14, 2007), 72 FR 13338 (March
21, 2007) (SR-Phlx-2007-12).
    \8\ Currently, the following option classes, listed by symbol,
are traded in the Penny Pilot Program: QQQQ, IWM, SMH, GE, AMD,
MSFT, INTC, CAT, WFMI, TXN, A, FLEX, and SUNW. See Securities
Exchange Act Release No. 55290 (February 13, 2007), 72 FR 8051
(February 22, 2007) (SR-Phlx-2007-05). The Penny Pilot Program is
scheduled to expire on July 26, 2007. If the Penny Pilot Program is
not extended, the Exchange intends to file a separate proposed rule
change to make any necessary changes to the payment for order flow
pilot dates.
    \9\ Russell 20007[supreg] is a trademark and service mark of the
Frank Russell Company, used under license. Neither Frank Russell
Company's publication of the Russell Indexes nor its licensing of
its trademarks for use in connection with securities or other
financial products derived from a Russell Index in any way suggests
or implies a representation or opinion by Frank Russell Company as
to the attractiveness of investment in any securities or other
financial products based upon or derived from any Russell Index.
Frank Russell Company is not the issuer of any such securities or
other financial products and makes no express or implied warranties
of merchantability or fitness for any particular purpose with
respect to any Russell Index or any data included or reflected
therein, nor as to results to be obtained by any person or any
entity from the use of the Russell Index or any data included or
reflected therein.
    \10\ The term ``AUTOM'' is used interchangeably with the term
``Phlx XL,'' the Exchange's fully electronic trading platform for
options. The Exchange intends to file a separate proposed rule
change to update its rules to reflect that orders are now delivered
electronically over Phlx XL.
    \11\ Specialists and Directed ROTs who participate in the
Exchange's payment for order flow program are assessed a payment for
order flow fee, in addition to ROTs. Therefore, the payment for
order flow fee is assessed, in effect, on equity option transactions
between a customer and an ROT, a customer and a Directed ROT, or a
customer and a specialist.
    \12\ Electronically-delivered orders do not include orders
delivered through the Floor Broker Management System pursuant to
Exchange Rule 1063.
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    The purpose of making minor technical changes to the payment for
order flow fee section of the Exchange's Summary of Equity Option and
RUT and RMN Charges fee schedule is to delete obsolete words.
Additionally, the purpose of deleting the words ``equity option,''
which appear in front of the payment for order flow fee section is to
more clearly reflect that RUT and RMN, although index options, are also
assessed payment for order flow charges.\13\
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    \13\ See Securities Exchange Act Release No. 55473 (March 14,
2007), 72 FR 13338 (March 21, 2007) (SR-Phlx-2007-12) (The Exchange
assesses equity option charges, including payment for order flow
charges, on options on RUT and RMN).
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    This proposal, consistent with the Exchange's current payment for
order flow program, will remain in effect as a pilot program that is
scheduled to expire on the same date as the one-year pilot program in
effect in connection with the provisions of Exchange Rule 1080(l)
relating to Directed Orders.\14\
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    \14\ See supra, note 5.
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2. Statutory Basis
    The Exchange believes that the proposed rule change to amend its
schedule of fees is consistent with Section 6(b) of the Act \15\ in
general, and Section 6(b)(4) of the Act \16\ in particular, in that it
is an equitable allocation of reasonable fees and other charges among
Exchange members.
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    \15\ 15 U.S.C. 78f(b).
    \16\ 15 U.S.C. 78f(b)(4).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The foregoing proposed rule change has been designated as a fee
change pursuant to Section 19(b)(3)(A)(ii) of the Act \17\ and Rule
19b-4(f)(2) \18\ thereunder, because it establishes or changes a due,
fee, or other charge imposed by the Exchange. Accordingly, the proposal
will take effect upon filing with the Commission. At any time within 60
days of the filing of such proposed rule change the Commission may
summarily abrogate such rule change if it appears to the Commission
that such action is necessary or appropriate in the public interest,
for the protection of investors, or otherwise in furtherance of the
purposes of the Act.
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    \17\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \18\ 17 CFR 240.19b-4(f)(2).
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IV. Solicitation of Comments

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

Electronic Comments

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

File Number SR-Phlx-2007-39 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.
All submissions should refer to File Number SR-Phlx-2007-39. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room. Copies of such
filing also will be available for inspection and copying at the
principal office of Phlx. All comments received will be posted without
change; the Commission does not edit personal identifying information
from submissions. You should submit only information that you wish to
make available publicly. All submissions should refer to File Number
SR-Phlx-2007-39 and should be submitted on or before July 6, 2007.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\19\
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    \19\ 17 CFR 200.30-3(a)(12).
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Nancy M. Morris,
Secretary.
 [FR Doc. E7-11551 Filed 6-14-07; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 81, Number 120 (Wednesday, June 22, 2016)]
[Notices]
[Pages 40755-40756]
[FR Doc No: 2016-14708]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2012-0033]

Notice of Intent To Grant a Buy America Waiver to Palmetto
Railways, a Division of the South Carolina Department of Commerce, To
Use Wide-Span, Electric, Rail-Mounted Gantry Cranes

AGENCY: Federal Railroad Administration (FRA), United States Department
of Transportation (DOT).

ACTION: Notice of intent to grant Buy America waiver.

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SUMMARY: FRA is issuing this notice to advise the public it intends to
grant Palmetto Railways a waiver from FRA's Buy America requirement to
use four (4) wide-span, electric, rail-mounted gantry cranes (WSCs).

DATES: Written comments on FRA's determination to grant Palmetto's Buy
America waiver request should be provided to the FRA on or before June
29, 2016.

ADDRESSES: Please submit your comments by one of the following means,
identifying your submissions by docket number FRA-2012-0033. All
electronic submissions must be made to the U.S. Government electronic
site at http://www.regulations.gov. Commenters should follow the
instructions below for mailed and hand-delivered comments:
    (1) Web site: http://www.regulations.gov. Follow the instructions
for submitting comments on the U.S. Government electronic docket site;
    (2) Fax:<PHONE_NUMBER>;
    (3) Mail: U.S. Department of Transportation, 1200 New Jersey Avenue
SE., Docket Operations, M-30, Room W12-140, Washington, DC 20590-0001;
or
    (4) Hand Delivery: Room W12-140 on the first floor of the West
Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    Instructions: All submissions must reference the ``Federal Railroad
Administration'' and include docket number FRA-2012-0033. Due to
security procedures in effect since October 2001, mail received through
the U.S. Postal Service may be subject to delays. Parties submitting
responses to this notice should consider using an express mail firm to
ensure the prompt filing of any submissions not filed electronically or
by hand. Note that all submissions received, including any personal
information therein, will be posted without change or alteration to
http://www.regulations.gov. For more information, you may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477), or visit http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT:  Mr. John Johnson, Attorney-Advisor,
FRA Office of Chief Counsel, 1200 New Jersey Avenue SE., Mail Stop 10,
Washington, DC 20590,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:  FRA provides information on its reasons for
granting this waiver in a letter to Palmetto Railways, quoted below:

Jeffrey M. McWhorter
President & CEO
Palmetto Railways
540 East Bay Street
Charleston, SC 29403
Re: Request for Waiver of Buy America Requirement for Wide-Span,
Electric, Rail-Mounted Gantry Cranes

    Dear Mr. McWhorter:

    This letter is in response to your request that the Federal
Railroad Administration (FRA) grant Palmetto Railways (Palmetto), a
division of the South Carolina Department of Commerce, a waiver from
FRA's Buy America policy applicable to FRA's Railroad Rehabilitation
& Improvement Financing (RRIF) loan program. Palmetto requests a
waiver to purchase four (4) wide-span, electric, rail-mounted gantry
cranes (WSCs) because no company manufactures WSCs in the United
States. Palmetto plans to use the WSCs at a brand new Intermodal
Container Transfer Facility (ICTF) on the site of the former
Charleston Navy Base, located in the City of North Charleston, South
Carolina. The total estimated cost of the WSCs is $[ ] or 8.2
percent of the total investment of approximately $[ ] to construct
the ICTF.
    For the reasons set forth below, FRA is granting Palmetto's
waiver request.
    FRA applies 49 U.S.C. 24405(a)(1) to RRIF loans. Section
24405(a)(1) requires that the steel, iron, and manufactured goods
used in a project be produced in the United States. FRA may waive
the Buy America requirements if FRA finds that: (A) applying the
requirements would be inconsistent with the public interest; (B) the
steel, iron, and goods manufactured in the United States are not
produced in sufficient and reasonably available amounts or are not
of a satisfactory quality; (C) rolling stock or power train
equipment cannot be bought or delivered to

the United States within a reasonable time; or (D) including
domestic material will increase the cost of the overall project by
more than 25 percent.
    FRA concludes a waiver is appropriate because domestically-
produced WSCs meeting Palmetto's specification for the ICTF project
are not currently produced in the United States.
    FRA bases this determination on the following:
     While there are domestic manufacturers for smaller,
intermodal cranes, there are no U.S. manufacturers of large and
wide-span intermodal cranes for ports;
     In 2011, U.S. Department of Transportation's Maritime
Administration (MARAD) determined it had been fifteen years since
mobile harbor cranes were manufactured in the United States and
issued a waiver for foreign mobile harbor cranes. See 76 FR 14457
(March 16, 2011). This finding comports with previous waivers for
cranes granted by MARAD in 2010 and the Federal Highway
Administration (FHWA) in 2009. See 75 FR 68661 (November 8, 2010)
and 74 FR 51363 (October 6, 2009), respectively;
     In 2013, the National Institute of Standards and
Technology's Hollings Manufacturing Extension Partnership (NIST-MEP)
scouted for domestic rail-mounted and rubber tire mobile harbor
cranes for intermodal containers and did not locate any U.S.
manufacturers;
     In 2015, NIST-MEP scouted for domestic large, container
vessel ship-to-shore gantry cranes and did not locate any U.S.
manufacturers currently manufacturing these cranes;
     In 2015, Palmetto conducted extensive market research
about active WSC manufacturers and found that they do not
manufacture WSCs in the United States;
     In January 2015, FHWA granted a Buy America waiver for
non-domestic harbor cranes after concluding that there are no
domestic manufacturers. See 80 FR 3005 (January 21, 2015);
     On February 9, 2015, FRA provided public notice of this
waiver request and a 15-day opportunity for comment on its Web site.
FRA also emailed notice to over 6,000 persons who have signed up for
Buy America notices through ``GovDelivery.'' See https://www.fra.dot.gov/Page/P0783. FRA received no comments;
     In May 2015, FHWA granted another Buy America waiver
for cargo cranes after concluding that there are no domestic
manufacturers. See 80 FR 29790 (May 22, 2015); and
     In January 2016, FRA independently confirmed there are
no domestic WSC manufacturers. FRA discussed the U.S. market with
crane/intermodal experts from several port terminals and railroad
intermodal operations with experience purchasing a variety of crane
equipment, including WSC cranes.
    FRA encourages Palmetto to follow through with the bidding
process described in its waiver request, including Palmetto's
expectation to weight ``the ability of a supplier to offer a
technically compliant, cost-effective solution that maximizes U.S.-
origin content over the lifecycle of the WSCs.'' FRA is publishing
notice of its decision to grant Palmetto's waiver request in the
Federal Register to provide notice of such finding and an
opportunity for public comment after which this waiver will become
effective. This waiver applies only to the WSCs for Palmetto's
procurement as identified in its waiver request.
    Questions about this letter can be directed to, John Johnson,
Attorney-Advisor, at<EMAIL_ADDRESS>or<PHONE_NUMBER>.

Sincerely,

Sarah E. Feinberg,
Administrator.

    Issued in Washington, DC, on June 16, 2016.
Amitabha Bose,
Chief Counsel.

[FR Doc. 2016-14708 Filed 6-21-16; 8:45 am]
 BILLING CODE 4910-06-P


[Federal Register Volume 84, Number 241 (Monday, December 16, 2019)]
[Rules and Regulations]
[Pages 68331-68334]
[FR Doc No: 2019-27046]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 310

[Docket No. FDA-2017-N-6924]
RIN 0910-AH47

Regulation Requiring an Approved New Drug Application for Drugs
Sterilized by Irradiation

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
issuing a final rule repealing a regulation that requires an FDA-
approved new drug application (NDA) or abbreviated new drug application
(ANDA) for any drug product that is sterilized by irradiation (the
irradiation regulation). Repealing the irradiation regulation will mean
that over-the-counter (OTC) drug products that are generally recognized
as safe and effective, are not misbranded, and comply with all
applicable regulatory requirements can be marketed legally without an
NDA or ANDA, even if they are sterilized by irradiation. FDA is taking
this action because the irradiation regulation is out of date and
unnecessary.

DATES: This rule is effective January 15, 2020.

ADDRESSES: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number found in brackets in the heading of this final rule into
the ``Search'' box and follow the prompts, and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Sudha Shukla, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5234, Silver Spring, MD 20993-0002, 301-
796-3345.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
II. Background
III. Legal Authority
IV. Comments on the Proposed Rule
V. Effective Date
VI. Economic Analysis of Impacts
VII. Analysis of Environmental Impact
VIII. Paperwork Reduction Act of 1995
IX. Federalism
X. Consultation and Coordination With Indian Tribal Governments
XI. Reference

I. Executive Summary

    In this final rule, FDA repeals the irradiation regulation, which
provided that any drug sterilized by irradiation was a new drug. OTC
drugs marketed pursuant to the OTC Drug Review that are generally
recognized as safe and effective, are not misbranded, and comply with
all applicable regulatory requirements now can be marketed legally
without an FDA-approved NDA or ANDA, even if the drugs are sterilized
by irradiation. As the Agency explained in the proposed rule published
in the Federal Register of September 12, 2018 (83 FR 46121), FDA is
taking this action because the Agency no longer concludes that drugs
sterilized by irradiation are necessarily new drugs. The technology of
controlled nuclear radiation for sterilization of drugs is now well
understood. In addition, drugs that are marketed pursuant to the OTC
Drug Review must be manufactured in compliance with current good
manufacturing practices (CGMPs). Appropriate and effective
sterilization of drugs, including by irradiation, is adequately
addressed by the CGMP requirements. Repealing the irradiation
regulation eliminates a requirement that is no longer necessary and
will not diminish public health protections.
    The estimated one-time costs of this rule range from $25 to $32.
Avoiding the unnecessary preparation and review of a premarket drug
application will generate an estimated one-time cost savings that range
from about $0.40 million to $2.16 million. Over 10 years with a 7
percent discount rate, the annualized net cost savings range from $0.05
million to $0.29 million, with a primary estimate of $0.06 million;
with a 3 percent discount rate, the annualized net cost savings range
from $0.05 million to $0.25 million, with a primary estimate of $0.05
million. Over an infinite horizon, we assume that one sponsor will
benefit from this deregulatory action every 10 years; the present value
of the net cost savings over the infinite horizon range from $0.76
million to $4.11 million with a 7

percent discount rate and from $1.52 million to $8.21 million with a 3
percent discount rate.

II. Background

    On February 24, 2017, E.O. 13777, ``Enforcing the Regulatory Reform
Agenda'' (https://www.gpo.gov/fdsys/pkg/FR-2017-03-01/pdf/2017-04107.pdf) was issued (82 FR 12285). One of the provisions in the E.O.
requires Agencies to evaluate existing regulations and make
recommendations to the Agency head regarding their repeal, replacement,
or modification, consistent with applicable law. As part of this
initiative, FDA is repealing the irradiation regulation as specified in
this rule.
    In the November 29, 1955, issue of the Federal Register, FDA issued
a statement of interpretation relating to the sterilization of drugs by
irradiation (20 FR 8747 at 8748).\1\ In the statement, FDA explained
that there was an interest in the utilization of newly developed
sources of radiation for the sterilization of drugs. The Agency went on
to state that it was necessary in the interest of protecting the public
health to establish by adequate investigations that the irradiation
treatment does not cause the drug to become unsafe or otherwise
unsuitable for use. For this reason, all drug products sterilized by
irradiation would be regarded as new drugs within the meaning of
section 201(p) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 321(p)), which would mean that an effective new drug
application would be required for such products.
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    \1\ Available at: https://www.loc.gov/item/fr020231/. A month
later, this provision was included in Sec.  3.45 in the
republication of chapter 21 of the Code of Federal Regulations (CFR)
in the Federal Register. See 20 FR 9525 at 9554 (December 20, 1955),
available at: http://cdn.loc.gov/service/ll/fedreg/fr020/fr020246/fr020246.pdf. In 1975, FDA republished and recodified the rule in 21
CFR 200.30. See 40 FR 13996 at 13997 (March 27, 1975), available at:
https://www.loc.gov/item/fr040060/.
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    In 1996, FDA proposed to revise the statement and consolidate it
with similar provisions into a single list of drugs that have been
determined by previous rulemaking procedures to be new drugs within the
meaning of section 201(p) of the FD&C Act (61 FR 29502 at 29503 to
29504 (June 11, 1996)). The Agency proposed to remove from the
regulatory text any existing background information describing the
Agency's basis for its determination of new drug status.
    In 1997, FDA finalized these provisions, now located in Sec.
310.502 (21 CFR 310.502), entitled ``Certain drugs accorded new drug
status through rulemaking procedures'' (62 FR 12083 at 12084 (March 14,
1997)). Section 310.502(a) sets forth a list of drugs that have been
determined by rulemaking procedures to be ``new drugs'' within the
meaning of section 201(p) of the FD&C Act. Included on the list was
``[s]terilization of drugs by irradiation'' (Sec.  310.502(a)(11)).
Because this regulation reflected an FDA determination that the drugs
on the list are ``new drugs,'' an NDA or ANDA had to be submitted and
approved by FDA before those drugs could be marketed legally.
    When the paragraph now reflected in Sec.  310.502(a)(11) was
published in 1955, the technology of controlled nuclear radiation for
sterilization of drugs was not well understood. In addition, neither
the OTC drug monograph system nor the CGMP requirements existed. The
authorizing legislation that the CGMP regulations implement, section
501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B)), was enacted in
1962 (``Drug Amendments of 1962,'' October 10, 1962, Public Law 87-781,
Title I, sec. 101), and the first CGMP regulations followed in 1963
(``Part 133--Drugs; Current Good Manufacturing Practice in Manufacture,
Processing, Packing, or Holding,'' 28 FR 6385 (June 20, 1963) available
at: https://www.loc.gov/item/fr028120/). The regulations creating
procedures for establishing OTC drug monographs were issued in 1972 (37
FR 9464 (May 11, 1972)) available at: https://www.loc.gov/item/fr037092/).
    Today, as the proposed rule explained (83 FR 46121 at 46123 to
46124), the technology of controlled nuclear radiation for
sterilization of drugs is well understood, and all drug products
marketed under the OTC Drug Review are subject to the requirement set
forth in 21 CFR 330.1(a) that they be manufactured in compliance with
current good manufacturing practices, as established by parts 210 and
211 (21 CFR parts 210 and 211). The CGMP requirements in parts 210 and
211 encompass sterilization, including by irradiation. As a result, as
discussed in the proposed rule (83 FR 46121 at 46124), Sec.
310.502(a)(11) can be repealed and manufacturers will still be
obligated to ensure that, if they use radiation: (1) The drug products
that they purport to be sterile are in fact sterile and (2) their use
of radiation does not have a detrimental effect on their drug products'
identity, strength, quality, purity, or stability.

III. Legal Authority

    We are issuing this final rule under the drugs and general
administrative provisions of the FD&C Act (sections 201, 301, 501, 502,
503, 505, 510, 701, 702, and 704 (21 U.S.C. 321, 331, 351, 352, 353,
355, 360, 371, 372, and 374)) and under section 361 of the Public
Health Service Act (PHS Act) (42 U.S.C. 264). The FD&C Act gives us the
authority to issue and enforce regulations designed to help ensure that
drug products are safe, effective, and manufactured according to
current good manufacturing practices, while section 361 of the PHS Act
gives us the authority to issue and enforce regulations designed to
prevent the introduction, transmission, or spread of communicable
diseases.

IV. Comments on the Proposed Rule

    We received five comment letters on the proposed rule by the close
of the comment period, all from individuals. Each of the five comment
letters contained general remarks supporting the proposed rule.

V. Effective Date

    This final rule is effective January 15, 2020.

VI. Economic Analysis of Impacts

    We have examined the impacts of the final rule under E.O. 12866,
E.O. 13563, E.O. 13771, the Regulatory Flexibility Act (5 U.S.C. 601-
612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).
E.O.s 12866 and 13563 direct us 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). E.O. 13771 requires that
the costs associated with significant new regulations ``shall, to the
extent permitted by law, be offset by the elimination of existing costs
associated with at least two prior regulations.'' We believe that this
final rule is not a significant regulatory action as defined by E.O.
12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because few entities will be affected and the net effect will
be cost savings to affected firms, we certify that the final rule will
not have a significant economic impact on a substantial number of small
entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before issuing ``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 $154 million, using the most current (2018) Implicit
Price Deflator for the Gross Domestic Product. This final rule would
not result in an expenditure in any year that meets or exceeds this
amount.
    Table 1 summarizes our estimate of the annualized costs and
benefits of the final rule.

                                       Table 1--Summary of Benefits, Costs, and Distributional Effects of the Rule
                                                                       [$ million]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Units
                                                                           ------------------------------------
               Category                   Primary       Low        High                               Period                      Notes
                                         estimate    estimate    estimate      Year      Discount     covered
                                                                              dollars    rate (%)     (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized $millions/          $0.06       $0.05       $0.29        2018           7          10  Benefits are cost savings.
     year.                                    0.05        0.05        0.25        2018           3          10  Benefits are cost savings.
    Annualized Quantified.............  ..........  ..........  ..........        2018           7          10
                                        ..........  ..........  ..........        2018           3          10
                                       ------------------------------------------------------------------------
    Qualitative.......................

--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
    Annualized Monetized $millions/           0.00        0.00        0.00        2018           7          10  Less than $100.
     year.                                    0.00        0.00        0.00        2018           3          10  Less than $100.
    Annualized Quantified.............  ..........  ..........  ..........        2018           7          10
                                        ..........  ..........  ..........        2018           3          10
                                       ------------------------------------------------------------------------
    Qualitative.......................

--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
    Federal Annualized Monetized              0.16        0.16        0.16        2018           7          10  User Fee.
     $millions/year.                          0.14        0.14        0.14        2018           3          10  User Fee.
                                       ------------------------------------------------------------------------
                                        From:
                                        To:
                                       -----------------------------------------------------------------------------------------------------------------
    Other Annualized Monetized          ..........  ..........  ..........        2018           7          10
     $millions/year.                    ..........  ..........  ..........        2018           3          10
                                       ------------------------------------------------------------------------
                                        From:
                                        To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
    State, Local, or Tribal Government: None.
    Small Business: None.
    Wages: None.
    Growth: None.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    In line with Executive Order 13771, in table 2 we estimate present
and annualized values of costs and cost savings over an infinite time
horizon. With a 7 percent discount rate, the estimated annualized net
cost-savings equal $0.06 million in 2016 dollars over an infinite
horizon. Based on these cost savings, this final rule would be
considered a deregulatory action under E.O. 13771.

                                                         Table 2--Executive Order 13771 Summary
                                                 [In $ millions 2016 dollars, over an infinite horizon]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                            Lower bound     Upper bound                     Lower bound     Upper bound
                                                           Primary (7%)        (7%)            (7%)        Primary (3%)        (3%)            (3%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Present Value of Costs..................................           $0.00           $0.00           $0.00           $0.00           $0.00           $0.00
Present Value of Cost Savings...........................            0.88            0.75            4.01            1.75            1.50            8.01
Present Value of Net Costs..............................          (0.88)          (0.75)          (4.01)          (1.75)          (1.50)          (8.01)
Annualized Costs........................................            0.00            0.00            0.00            0.00            0.00            0.00
Annualized Cost Savings.................................            0.06            0.05            0.28            0.05            0.05            0.24
Annualized Net Costs....................................          (0.06)          (0.05)          (0.28)          (0.05)          (0.05)          (0.24)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: Net costs are calculated as costs minus cost savings. Values in parentheses denote net negative costs (i.e., cost-savings).

    We have developed a comprehensive Economic Analysis of Impacts that
assesses the impacts of the final rule. The full analysis of economic
impacts is available in the docket for this final rule (Ref. 1) and at:
https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

VII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(h) and 25.31(a) 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.

VIII. Paperwork Reduction Act of 1995

    This final rule contains no collections of information. Therefore,
clearance by the Office of Management and Budget

under the Paperwork Reduction Act of 1995 is not required.

IX. Federalism

    We have analyzed this final rule in accordance with the principles
set forth in E.O. 13132. We have 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, we conclude that the rule does not contain
policies that have federalism implications as defined in the E.O. and,
consequently, a federalism summary impact statement is not required.

X. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this rule in accordance with the principles set
forth in E.O. 13175. We have determined that the rule does not contain
policies that have substantial direct effects on one or more Indian
Tribes, on the relationship between the Federal Government and Indian
Tribes, or on the distribution of power and responsibilities between
the Federal Government and Indian Tribes. Accordingly, we conclude that
the rule does not contain policies that have tribal implications as
defined in the E.O. and, consequently, a tribal summary impact
statement is not required.

XI. Reference

    The following reference is on display in the Dockets Management
Staff (see ADDRESSES), and is available for viewing by interested
persons between 9 a.m. and 4 p.m. Monday through Friday; it is also
available electronically at https://www.regulations.gov. FDA has
verified the website addresses, as of the date this document publishes
in the Federal Register, but websites are subject to change over time.
    1. FDA Final Regulatory Impact Analysis, ``Regulation Requiring an
Approved New Drug Application for Drugs Sterilized by Irradiation,''
available at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

List of Subjects in 21 CFR Part 310

    Administrative practice and procedure, Drugs, Labeling, Medical
devices, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and the
Public Health Service Act and under authority delegated to the
Commissioner of Food and Drugs, 21 CFR part 310 is amended as follows:

PART 310--NEW DRUGS

0
1. The authority citation for part 310 continues to read as follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360b-360f,
360j, 360hh-360ss, 361(a), 371, 374, 375, 379e, 379k-1; 42 U.S.C.
216, 241, 242(a), 262.

0
2. In Sec.  310.502, revise paragraph (a) introductory text and remove
and reserve paragraph (a)(11) to read as follows:

Sec.  310.502   Certain drugs accorded new drug status through
rulemaking procedures.

    (a) The drugs listed in this paragraph (a) have been determined by
rulemaking procedures to be new drugs within the meaning of section
201(p) of the Federal Food, Drug, and Cosmetic Act. An approved new
drug application under section 505 of the Federal Food, Drug, and
Cosmetic Act and part 314 of this chapter is required for marketing the
following drugs:
* * * * *

    Dated: December 9, 2019.
Brett P. Giroir,
Acting Commissioner of Food and Drugs.
[FR Doc. 2019-27046 Filed 12-13-19; 8:45 am]
BILLING CODE 4164-01-P


EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact: Autumn Metzger<PHONE_NUMBER>

FMC Corporation

4F8290

	EPA has received a pesticide petition 4F8290 from FMC Corporation, 1735 Market Street, Philadelphia, PA 19103, proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend the tolerances in 40 CFR part 180.418 for residues of zeta-cypermethrin in or on the raw agricultural commodities Corn, field, forage from 0.2 parts per million (ppm) to 9.0 ppm; Corn, field, stover from 3.0 ppm to 30.0 ppm; and Corn, pop, stover from 3.0 ppm to 30.0 ppm.  EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of  FDDCA; however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the petition.  Additional data may be needed before EPA rules on the petition.

A. Residue Chemistry

	1. Plant metabolism.  The metabolism of cypermethrin and zeta-cypermethrin in plants is adequately understood.  Studies have been conducted to delineate the metabolism of radiolabeled cypermethrin in various crops all showing similar results.  The residue of concern is the parent compound only.

	2. Analytical method.  There is a practical analytical method for detecting and measuring levels of cypermethrin and zeta-cypermethrin in or on food with a limit of detection that allows monitoring of food with residues at or above the levels set in these tolerances (Gas Chromatography with Electron Capture Detection (GC/ECD).

	3. Magnitude of residues.  Crop field trial residue data from studies conducted at the maximum label rates for representative commodities for field corn show that the proposed zeta-cypermethrin tolerances in or on the raw agricultural commodities corn, field, forage at 9.0 parts per million (ppm); corn, field, stover at 30.0 ppm; and corn, pop, stover at 30.0 ppm will not be exceeded when zeta-cypermethrin products labeled for these uses are applied as directed.

B. Toxicological Profile

	1. Acute toxicity.  For the purposes of assessing acute dietary risk, the BMDL1SD of 7.16 mg/kg/day based on neurotoxicity (motor activity) was used to determine the acute Population Adjusted Dose (aPAD) of 0.07 mg/kg/day.  The BMD of 11.20 mg/kg/day was based on clinical signs.  This acute dietary endpoint is used to determine acute dietary risks to all population subgroups.
	2. Genotoxicty.  The following genotoxicity tests were all negative: in vivo chromosomal aberration in rat bone marrow cells; in vitro cytogenic chromosome aberration; unscheduled DNA synthesis; CHO/HGPT mutagen assay; weakly mutagenic: gene mutation (Ames).
	3. Reproductive and developmental toxicity.  No evidence of additional sensitivity to young rats was observed following pre- or postnatal exposure to zeta-cypermethrin.
      a. A two-generation reproductive toxicity study with zeta-cypermethrin in rats demonstrated a NOEL of 7.0 mg/kg/day and a LOEL of 27.0 mg/kg/day for parental/systemic toxicity based on body weight, organ weight, and clinical signs.  There were no adverse effects in reproductive performance.  The NOEL for reproductive toxicity was considered to be > 45.0 mg/kg/day (the highest dose tested).
      b. A developmental study with zeta-cypermethrin in rats demonstrated a maternal NOEL of 12.5 mg/kg/day and a LOEL of 25 mg/kg/day based on decreased maternal body weight gain, food consumption and clinical signs.  There were no signs of developmental toxicity at 35.0 mg/kg/day, the highest dose level tested.
      c. A developmental study with cypermethrin in rabbits demonstrated a maternal NOEL of 100 mg/kg/day and a LOEL of 450 mg/kg/day based on decreased body weight gain.  There were no signs of developmental toxicity at 700 mg/kg/day, the highest dose level tested.
      d. In a rat developmental neurotoxicity (DNT) study there were no maternal effects at the highest dose tested.  The offspring NOAEL and LOAEL were set at 7.4 and 17.3 mg/kg/day, respectively, based on reduced body weight and body weight gain in female pups.
	4. Subchronic toxicity.  The short- and intermediate-term incidental oral exposure risk assessment is based on a NOAEL of 7.4 mg/kg/day from the developmental neurotoxicity study in rats.  The endpoint of concern is the decreased body weight seen in the offspring at the LOAEL of 17.3 mg/kg/day.  The dose and endpoint are appropriate for the route (oral), population (infants and children) and duration (seen during lacation days 13 - 21) of concern.
	5. Chronic toxicity. a. A zeta-cypermethrin NOEL of 6.0 mg/kg/day is available from a cypermethrin chronic feeding study in dogs.  The endpoint was based on clinical signs.
b. Cypermethrin is classified as a Group C chemical (possible human carcinogen with limited evidence of carcinogenicity in animals) based on an increased incidence of lung adenomas and combined adenomas plus carcinomas in female mice.  The presence of common benign tumors (lung adenomas) in one species (mice) and one sex (female), with no increase in the proportion of malignant tumors or decrease in the time-to-tumor occurrence, together with the lack of mutagenic activity, was not considered strong enough evidence to warrant a quantitative estimation of human cancer risk.  The chronic reference dose has been considered protective for all chronic effects as well as any potential cancer effects.

	6. Animal metabolism.  The metabolism of cypermethrin in animals is adequately understood.  Cypermethrin has been shown to be rapidly absorbed, distributed, and excreted in rats when administered orally.  Cypermethrin is metabolized by hydrolysis and oxidation.
      7. Metabolite toxicology.  The Agency has previously determined that the metabolites of cypermethrin are not of toxicological concern and need not be included in the tolerance expression nor in the risk exposure assessments.
	8. Endocrine disruption. Cypermethrin has been tested in eight of the eleven assays that are part of the EDSP (Endocrine Disruptor Screening Program) Tier 1 testing scheme and other scientifically relevant information (OSRI) is available that satisfies the requirements of the other three Tier 1 assays based on prior USEPA evaluation and acceptance of published literature studies.  The weight of evidence derived from the EDSP Tier 1 battery studies, OSRI studies, and other FIFRA guideline studies support the conclusion that cypermethrin does not alter the estrogen, androgen or steroidogenesis pathways of test systems.  There is no evidence to support a conclusion that cypermethrin results in alteration of either the hypothalamic-pituitary-gonadal axis or the hypothalamic-pituitary-thyroidal axis.  The available database and weight of evidence evaluation indicate that cypermethrin does not interact with endocrine systems in the EDSP Tier 1 screening and does not cause toxicity to endocrine organs and systems in higher tier in vivo Guideline studies.

C. Aggregate Exposure
	1. Dietary exposure
      i. Food. For the purposes of assessing the potential dietary exposure to zeta-cypermethrin the established tolerances were used (40 CFR 180.418).  In addition, amended tolerances for corn, field, forage; corn, field, stover; and corn, pop, stover have been proposed in this petition.  As corn forage and stover are animal feed commodities and a previous dietary assessment was made using the currently established tolerance on animal feed, nongrass, at 40 ppm (IR-4 zeta-cypermethrin tolerance petition for tropical fruits (PP 0E7804, Fed Reg Vol. 76, No. 38, February 25, 2011) this petition to amend the tolerances on corn, field, forage to 9.0 ppm; corn, field, stover to 30.0 ppm; and corn, pop, stover to 30.0 ppm will not change the results of the dietary exposure risk assessment.  For the purposes of assessing the potential dietary exposure for the existing and the proposed amended tolerances, available information on anticipated residues, monitoring data and percent crop treated has been utilized as follows:
Acute exposure and risk.  The acute dietary exposure estimates for zeta-cypermethrin, as estimated by the dietary risk assessment, do not appear to be of concern.  The BMDL1SD of 7.16 mg/kg/day from the zeta-cypermethrin acute neurotoxicity study in rats with an uncertainty factor (UF) of 100 (acute RfD = 0.07 mg/kg/day) and an additional FQPA SF of 3x for children <6 years old was used to determine acute dietary risks to all population subgroups (DP Numbers: D403600 and D403615).  Available information on anticipated residues, monitoring data and percent crop treated was incorporated into a Tier 3 analysis, using Monte Carlo modeling for commodities that may be consumed in a single serving.  Drinking water was incorporated directly in the dietary assessment.  The acute drinking water concentration of 3.77 ppb was provided in EFED's February 22, 2011 assessment (DP Numbers: D378901 and D385246).  The most highly exposed subpopulation for the acute scenario is children 1-2 years old and infants <1 yr, which utilize 87% of the aPAD at the 99.9th percentile of exposure.  The acute risk estimate for the general population utilizes 18% of the aPAD at the 99.9th percentile of exposure.
The results of the analysis show that for all populations, the estimated exposures are below the Agency's level of concern (< 100% aPAD).
Chronic exposure and risk.  A chronic dietary exposure/risk assessment has been performed for zeta-cypermethrin using the acute reference dose (aRfD) of 0.023 mg/kg/day for zeta-cypermethrin paired with average dietary exposure estimates for cypermethrins (DP Numbers: D403600 and D403615).  Available information on anticipated residues, monitoring data and percent crop treated was incorporated into the analysis.  The chronic dietary risk estimates for food and drinking water are below the EPA level of concern.  The chronic exposure for the general U.S. population is 4% of the cPAD.  The most highly exposed subpopulation for the chronic scenario is children 1-2 years old, utilizing 15% of the cPAD.
 For the chronic analysis, anticipated residue levels are utilized for most crops.  These anticipated residues were derived from previous analyses for cypermethrin and zeta-cypermethrin.  Anticipated residues (average field trial values) were calculated for the proposed amended uses from the field trial data.  Exposure estimates are based on these anticipated residues, USDA PDP monitoring data, and processing factors.  Drinking water was incorporated directly in the dietary assessment.  The chronic drinking water concentration of 0.066 ppb was provided in EFED's Feb 22, 2011 review (DP Numbers: D378901 and D385246).
The results of the analysis show that for all populations, the exposures are far below a level of concern (< 100% cPAD).
	ii. Drinking water.  For cypermethrin /zeta-cypermethrin, comprehensive water monitoring data do not exist for use in a dietary exposure analysis and risk assessment in drinking water.  Therefore drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the environmental fate characteristics of cypermethrin/zeta-cypermethrin.
Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated environmental concentrations (EECs) of cypermethrin/zeta-cypermethrin for acute exposures are estimated to be 3.77 parts per billion (ppb) for surface water and 0.0036 ppb for ground water.  The EECs for chronic exposures are estimated to be 0.047 ppb for surface water and < 0.0036 ppb for ground water.  These estimates are based on EFED's Feb 22, 2011 review (DP Numbers: D378901 and D385246).  Version 1.06 of the EFED model PRZM-GW was also used to estimate groundwater contribution to the dietary risk cup, but estimated residues in water were lower than those estimated from SCI-GROW.
Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model.  For acute dietary risk assessment, the water concentration value of 3.77 ppb was used to assess the contribution to drinking water.  For chronic dietary risk assessment, the water concentration value 0.066 ppb was used to assess the contribution to drinking water.
	2. Non-dietary exposure.  Occupational and residential risks were assessed for cypermethrin and zeta-cypermethrin under the re-registration process for cypermethrin.  For occupational and residential handler risk, short- and intermediate-term dermal risks were not assessed for occupational handlers since no short- or intermediate-term dermal endpoints were identified.  When data were available to assess risks, short- and intermediate-term inhalation risks to occupational and residential handlers are below the Agency's level of concern (i.e., MOE >100) at baseline.  Occupational and residential post-application exposures and risks were not assessed for applications of cypermethrin and zeta-cypermethrin to residential and commercial lawns, and in and around industrial, commercial, and residential premises since no short- or intermediate-term dermal endpoints of concern were identified and long-term exposures are not expected for tasks involving any of the registered use patterns.  Post-application risks to toddlers from incidental oral ingestion were assessed using a short-term incidental oral endpoint (10 mg/kg/day) for zeta-cypermethrin.  For residential post-application risks, MOEs are not a concern for any of the oral non-dietary scenarios, because they are greater than 100 and do not exceed HED's level of concern (i.e., MOE < 100) for risk assessments in non-occupational settings.  When the post-application risks to toddlers from incidental oral ingestion following applications to lawns were combined, the results indicate that the combined risks are below EPA's level of concern.

D. Cumulative Effects
Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider "available information concerning the cumulative effects of a particular pesticide's residues and "other substances that have a common mechanism of toxicity.
   Cypermethrin is a member of the pyrethroid class of pesticides.  EPA has developed a draft science policy document on the proposed common mechanism of toxicity for naturally-occurring pyrethrins and pyrethroids.  This document was supported by the FIFRA Scientific Advisory Panel.  In addition, there is ongoing research by the EPA's Office of Research and Development to make improvements to the SHEDS model as well as development of physiologically-based pharmacokinetic models.  When available, the Agency will consider this research and make a determination of a basis for assessing cumulative risk.  FMC will submit information for EPA to consider concerning potential cumulative effects of zeta-cypermethrin consistent with the schedule established by EPA at 62 Federal Register 42020 (Aug. 4, 1997) and other EPA publications pursuant to the Food Quality Protection Act.

E. Safety Determination
	1. U.S. population.  Based on the current risk assessments, there is a reasonable certainty that no harm will result to the general population from exposure to zeta-cypermethrin residues from the proposed amended uses.
	2. Infants and children.  In assessing the potential for additional sensitivity of infants and children to residues of zeta-cypermethrin, data from developmental toxicity studies in the rat and rabbit, and a two-generation reproductive study in the rat, and a developmental neurotoxicity study in the rat were considered.  The data demonstrated no indication of increased sensitivity from in utero and/or postnatal exposure to zeta-cypermethrin or cypermethrin.  FFDCA section 408 provides that EPA may apply an additional margin of safety for infants and children in the case of threshold effects to account for pre- and post-natal toxicity and the completeness of the database.  For zeta-cypermethrin, the FQPA safety factor has been set at 3X based on the increased quantitative susceptibility seen in the scientific literature related to pyrethroid pharmacokinetics (D381210, E. Scollon and A. Lowit, 27-June-2011).
   Based on the current risk assessment, there is reasonable certainty that no harm to infants and children will result from aggregate acute or chronic dietary (food and drinking water) exposure to zeta-cypermethrin residues.

F. International Tolerances
Although a Codex MRL of 10 mg/Kg for cypermethrin (including alpha- and zeta-cypermethrin) was established in 2009 on straw and fodder (dry) of cereal grains there are no established Codex, Canadian or Mexican residue limits for residues of cypermethrin or zeta-cypermethrin in or on the specific commodities of field corn forage, field corn stover, and pop corn stover.


[Federal Register: December 27, 2005 (Volume 70, Number 247)]
[Notices]
[Page 76482-76483]
[DOCID:fr27de05-74]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-52978; File No. SR-NASD-2005-141]

Self-Regulatory Organizations; National Association of Securities
Dealers, Inc.; Notice of Filing and Immediate Effectiveness of Proposed
Rule Change and Amendment No. 1 Thereto To Modify the Execution Fees
for Quotes and Orders Executed in the Nasdaq Opening Cross

December 19, 2005.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on December 5, 2005, the National Association of Securities Dealers,
Inc. (``NASD''), through its subsidiary, The Nasdaq Stock Market, Inc.
(``Nasdaq''), filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II
and III below, which Items have been prepared by Nasdaq. On December 9,
2005, Nasdaq filed Amendment No. 1 to the proposed rule change.\3\
Nasdaq has designated this proposal as establishing or changing a due,
fee, or other charge imposed by a self-regulatory organization pursuant
to Section 19(b)(3)(A) of the Act,\4\ and Rule 19b-4(f)(2)
thereunder,\5\ which renders the proposal effective upon filing with
the Commission. The Commission is publishing this notice to solicit
comments on the proposed rule change, as amended, from interested
persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ In Amendment No. 1, Nasdaq made non-substantive changes to
the text of the proposed rule change.
    \4\ 15 U.S.C. 78s(b)(3)(A).
    \5\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Nasdaq proposes to modify the execution fees for quotes and orders
in the Nasdaq Opening Cross. Nasdaq will implement the proposed rule
change on January 3, 2006. Additions are italicized, and deletions are
in brackets.
* * * * *

7010. System Services

    (a)-(h) No change
    (i) Nasdaq Market Center and Brut Facility Order Execution
    (1)-(3) No change.
    (4) Opening Cross

[For a period of three months commencing on the date Nasdaq implements
its Opening Cross (as described in Rule 4704(d)), members shall not be
charged Nasdaq Market Center execution fees, or receive Nasdaq Market
Center liquidity provider credits, for those quotes and orders executed
in the Nasdaq Opening Cross.]

    Commencing on January 1, 2006, members shall be assessed the
following Nasdaq Market Center execution fees for quotes and orders
executed in the Nasdaq Opening Cross:
    Market-on-Open, Limit-on-Open and Day orders executed in the Nasdaq
Opening Cross--$0.0005 per share executed for the net number of buy and
sell shares up to a maximum of $10,000 per firm per month
    All other quotes and orders executed in the Nasdaq Opening Cross--
No charge for execution
    (5) and (6) No change.
    (j)-(w) No change.
* * * * *

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

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

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

1. Purpose
    Nasdaq has determined to establish the following pricing for the
Nasdaq Opening Cross beginning January 3, 2006. Nasdaq will assess a
fee of $0.0005 per share executed during the Nasdaq Opening Cross for
all Market-on-Open, Limit-on-Open, and Day orders that are executed in
the Opening Cross. That fee will be assessed on the difference between
the total number of shares of buy (sell) interest minus the total
number of shares of sell (buy) interest executed by that firm for all
stocks.
    The fee will be capped at $10,000 per firm per month for all stocks
combined. At this time, Nasdaq will assess no fees and offer no rebates
for quotations and other orders executed during the Nasdaq Opening
Cross. Nasdaq will monitor the effectiveness of the proposed pricing
schedule in preserving and enhancing the success of the Nasdaq Opening
Cross to date.
2. Statutory Basis
    Nasdaq believes that the proposed rule change is consistent with
Section 15A of the Act,\6\ in general, and Section 15A(b)(5) \7\ of the
Act, in particular, in that it provides for the equitable allocation of
reasonable dues, fees, and other charges among members and issuers and
other persons using any facility or system which the NASD operates or
controls.
    The proposed fees for Market-on-Open, Limit-on-Open, and Day orders
are consistent with the statute in that they are designed to result in
an execution charge approximating the execution charge for quotes and
orders entered and executed in the Nasdaq Market Center throughout the
trading day. Assessing no fee and offering no rebate for quotations and
other orders executed during the Nasdaq Opening Cross is consistent
with the statute because it is designed to encourage the entry of
Imbalance Only orders to minimize imbalances resulting from the Opening
Cross algorithm, and to preserve the Opening Cross liquidity provided
by quotations and orders from the continuous market.

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

    Nasdaq does not believe that the proposed rule change will impose
any

burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

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

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

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A) of the Act \8\ and subparagraph (f)(2) of Rule 19b-4
thereunder.\9\ At any time within 60 days of the filing of such
proposed rule change, the Commission may summarily abrogate such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.\10\ Nasdaq will
implement the proposed rule change on January 3, 2006.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78o-3.
    \7\ 15 U.S.C. 78o-3(b)(5).
    \8\ 15 U.S.C. 78s(b)(3)(A).
    \9\ 17 CFR 240.19b-4(f)(2).
    \10\ The effective date of the original proposed rule change is
December 5, 2005, and the effective date of Amendment No. 1 is
December 9, 2005. For purposes of calculating the 60-day period
within which the Commission may summarily abrogate the proposed rule
change, as amended, under Section 19(b)(3)(C) of the Act, the
Commission considers the period to commence on December 9, 2005, the
date on which Nasdaq submitted Amendment No. 1. See 15 U.S.C.
78s(b)(3)(C).
---------------------------------------------------------------------------

IV. Solicitation of Comments

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

Electronic Comments

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

File Number SR-NASD-2005-141 on the subject line.

Paper Comments

     Send paper comments in triplicate to Jonathan G. Katz,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-9303.
    All submissions should refer to File Number SR-NASD-2005-141. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments,

all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room. Copies of the
filing also will be available for inspection and copying at the
principal offices of the NASD. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-NASD-2005-141 and should be submitted on or before
January 17, 2006.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\11\
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Jonathan G. Katz,
Secretary.
 [FR Doc. E5-7860 Filed 12-23-05; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 83, Number 164 (Thursday, August 23, 2018)]
[Notices]
[Pages 42659-42662]
[FR Doc No: 2018-18216]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3079]

Request for Nominations for Voting Members on Public Advisory
Panels or Committees; Device Good Manufacturing Practice Advisory
Committee and the Medical Devices Advisory Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is requesting
nominations for voting members to serve on the Device Good
Manufacturing Practice Advisory Committee and device panels of the
Medical Devices Advisory Committee in the Center for Devices and
Radiological Health. This annual notice is also in accordance with the
21st Century Cures Act, which requires the Secretary to provide an
annual opportunity for patients, representatives of patients, and
sponsors of medical devices that may be specifically the subject of a
review by a classification panel to provide recommendations for
individuals with appropriate expertise to fill voting member positions
on classification panels.
    FDA seeks to include the views of women and men, members of all
racial and ethnic groups, and individuals with and without disabilities
on its advisory committees and, therefore, encourages nominations of
appropriately qualified candidates from these groups.

DATES: Nominations received on or before October 22, 2018 will be given
first consideration for membership on the Device Good Manufacturing
Practice Advisory Committee and Panels of the Medical Devices Advisory
Committee. Nominations received after October 22, 2018 will be
considered for nomination to the committee as later vacancies occur.

ADDRESSES: All nominations for membership should be submitted
electronically by logging into the FDA Advisory Nomination Portal:
https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm or
by mail to Advisory Committee Oversight and Management Staff, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103,
Silver Spring, MD 20993-0002.

FOR FURTHER INFORMATION CONTACT: Regarding all nomination questions for
membership, contact the following persons listed in table 1:

             Table 1--Panel and Advisory Committee Contacts
------------------------------------------------------------------------
  Primary contact person or designated
             federal officer                      Committee/panel
------------------------------------------------------------------------
Joannie Adams-White, Office of the        Medical Devices Dispute
 Center Director, Center for Devices and   Resolution Panel.
 Radiological Health, Food and Drug
 Administration, 10903 New Hampshire
 Ave., Bldg. 66, Rm. 5519, Silver
 Spring, MD 20993,<PHONE_NUMBER>, email:
 [email protected].
LCDR Sara Anderson, Office of Device      Dental Products Panel.
 Evaluation, Center for Devices and       Hematology and Pathology
 Radiological Health, Food and Drug        Devices Panel.
 Administration, 10903 New Hampshire      Orthopaedic and Rehabilitation
 Ave., Bldg. 66, Rm. G616, Silver          Devices Panel.
 Spring, MD 20993,<PHONE_NUMBER>, email:   Radiological Devices Panel.
 [email protected].
Aden S. Asefa, Office of Device           Immunology Devices Panel.
 Evaluation, Center for Devices and       Microbiology Devices Panel.
 Radiological Health, Food and Drug       Neurological Devices Panel.
 Administration, 10903 New Hampshire      Ophthalmic Devices Panel.
 Ave., Bldg. 66, Rm. G642, Silver         Device Good Manufacturing
 Spring, MD 20993,<PHONE_NUMBER>, email:    Practice Advisory Committee.
 [email protected].
LCDR Patricio G. Garcia, Office of        Clinical Chemistry and
 Device Evaluation, Center for Devices     Clinical Toxicology Devices
 and Radiological Health, Food and Drug    Panel.
 Administration,10903 New Hampshire       Gastroenterology and Urology
 Ave., Bldg. 66, Rm. G610, Silver          Devices Panel.
 Spring, MD 20993,<PHONE_NUMBER>, email:   General and Plastic Surgery
 [email protected].              Devices Panel.
                                          Obstetrics and Gynecology
                                           Devices Panel.
Evella F. Washington, Office of Device    Anesthesiology and Respiratory
 Evaluation, Center for Devices and        Therapy Devices Panel.
 Radiological Health, Food and Drug       Circulatory System Devices
 Administration, 10903 New Hampshire       Panel.
 Ave., Bldg. 66, Rm. G640, Silver         Ear, Nose and Throat Devices
 Spring, MD 20993,<PHONE_NUMBER>, email:    Panel.
 [email protected].           General Hospital and Personal
                                           Use Devices Panel.
                                          Molecular and Clinical
                                           Genetics Devices Panel.
------------------------------------------------------------------------

    Information about becoming a member on an FDA advisory committee
can also be obtained by visiting FDA's website at https://www.fda.gov/AdvisoryCommittees/default.htm.

SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting
members for vacancies listed in table 2:

                        Table 2--Expertise Needed, Vacancies, and Approximate Date Needed
----------------------------------------------------------------------------------------------------------------
         Committee/panel expertise needed                     Vacancies               Approximate date needed
----------------------------------------------------------------------------------------------------------------
Device Good Manufacturing Practice Advisory         1 General Public               Immediately.
 Committee--Experts needed to provide cross-         Representative.               .............................
 cutting scientific or clinical expertise           2 Health Professional          6/1/2019.
 concerning the particular issue in dispute.         Representatives..
 Vacancies include a representative of the          1 Government Representative..
 interests of the general public and government
 and representatives of the interests of
 physicians and other health professionals.
Anesthesiology and Respiratory Therapy Devices      1............................  Immediately.
 Panel of the Medical Devices Advisory Committee--  3............................  11/30/2018.
 Anesthesiologists, pulmonary medicine
 specialists, or other experts who have
 specialized interests in ventilator support,
 pharmacology, physiology, or the effects and
 complications of anesthesia.
Circulatory System Devices Panel of the Medical     3............................  Immediately.
 Devices Advisory Committee--Interventional
 cardiologists, electrophysiologists, invasive
 (vascular) radiologists, vascular and
 cardiothoracic surgeons, and cardiologists with
 special interest in congestive heart failure.
Clinical Chemistry and Clinical Toxicology Panel    1............................  2/28/2019.
 of the Medical Devices Advisory Committee--
 Doctors of medicine or philosophy with experience
 in clinical chemistry (e.g., cardiac markers),
 clinical toxicology, clinical pathology, clinical
 laboratory medicine, and endocrinology.
Dental Products Panel of the Medical Devices        2............................  10/31/2018.
 Advisory Committee--Dentists, engineers, and
 scientists who have expertise in the areas of
 dental implants, dental materials,
 periodontology, tissue engineering, and dental
 anatomy.
Ear, Nose and Throat Devices Panel of the Medical   3............................  10/31/2018.
 Devices Advisory Committee--Otologists,
 neurotologists, audiologists.
Gastroenterology and Urology Devices Panel of the   0............................  N/A.
 Medical Devices Advisory Committee--
 Gastroenterologists, urologists, and
 nephrologists.
General and Plastic Surgery Devices Panel of the    1............................  Immediately.
 Medical Devices Advisory Committee--Surgeons       1............................  8/31/2018.
 (general, plastic, reconstructive, pediatric,
 thoracic, abdominal, pelvic and endoscopic);
 dermatologists; experts in biomaterials, lasers,
 wound healing, and quality of life; and
 biostatisticians.
General Hospital and Personal Use Devices Panel of  3............................  Immediately.
 the Medical Devices Advisory Committee--           3............................  12/31/2018.
 Internists, pediatricians, neonatologists,
 endocrinologists, gerontologists, nurses,
 biomedical engineers or microbiologists/infection
 control practitioners or experts.

Hematology and Pathology Devices Panel of the       1............................  2/28/2019.
 Medical Devices Advisory Committee--Hematologists
 (benign and/or malignant hematology),
 hematopathologists (general and special
 hematology, coagulation and homeostasis, and
 hematological oncology), gynecologists with
 special interests in gynecological oncology,
 cytopathologists, and molecular pathologists with
 special interests in development of predictive
 and prognostic biomarkers.
Immunology Devices Panel of the Medical Devices     1............................  Immediately.
 Advisory Committee--Persons with experience in     2............................  2/28/19.
 medical, surgical, or clinical oncology, internal
 medicine, clinical immunology, allergy, molecular
 diagnostics, or clinical laboratory medicine.
Medical Devices Dispute Resolution Panel of the     1............................  9/30/2018.
 Medical Devices Advisory Committee--Experts with
 broad, cross-cutting scientific, clinical,
 analytical, or mediation skills.
Microbiology Devices Panel of the Medical Devices   2............................  Immediately.
 Advisory Committee--Infectious disease (ID)
 clinicians (e.g. pulmonary disease specialists,
 sexually transmitted disease specialists,
 pediatric ID specialists, tropical diseases
 specialists) and clinical microbiologists
 experienced in emerging infectious diseases;
 clinical microbiology laboratory directors;
 molecular biologists with experience in in vitro
 diagnostic device testing; virologists;
 hepatologists; or clinical oncologists
 experienced with tumor resistance and
 susceptibility.
Molecular and Clinical Genetics Devices Panel of    3............................  Immediately.
 the Medical Devices Advisory Committee--Human      2............................  5/31/2019.
 genetics and in the clinical management of
 patients with genetic disorders, e.g.,
 pediatricians, obstetricians, neonatologists.
 Individuals with training in inborn errors of
 metabolism, biochemical and/or molecular
 genetics, population genetics, epidemiology and
 related statistical training, and clinical
 molecular genetics testing (e.g., genotyping,
 array comparative genomic hybridization (CGH),
 etc.) Individuals with experience in genetics
 counseling, medical ethics are also desired, and
 individuals with experience in ancillary fields
 of study will be considered.
Neurological Devices Panel of the Medical Devices   1............................  Immediately.
 Advisory Committee--Neurosurgeons
 (cerebrovascular and pediatric), neurologists
 (stroke, pediatric, pain management, and movement
 disorders), interventional neuroradiologists,
 psychiatrists, and biostatisticians.
Obstetrics and Gynecology Devices Panel of the      1............................  Immediately.
 Medical Devices Advisory Committee--Perinatology,  2............................  1/31/2019.
 embryology, reproductive endocrinology, pediatric
 gynecology, gynecological oncology, operative
 hysteroscopy, pelviscopy, electrosurgery, laser
 surgery, assisted reproductive technologies,
 contraception, postoperative adhesions, and
 cervical cancer and colposcopy; biostatisticians
 and engineers with experience in obstetrics/
 gynecology devices; urogynecologists; experts in
 breast care; experts in gynecology in the older
 patient; experts in diagnostic (optical)
 spectroscopy; experts in midwifery; labor and
 delivery nursing.
Ophthalmic Devices Panel of the Medical Devices     2............................  Immediately.
 Advisory Committee--Ophthalmologists specializing  3............................  10/31/2018.
 in cataract and refractive surgery and vitreo-
 retinal surgery, in addition to vision
 scientists, optometrists, and biostatisticians
 practiced in ophthalmic clinical trials.
Orthopaedic and Rehabilitation Devices Panel of     2............................  8/31/2018.
 the Medical Devices Advisory Committee--           1............................  8/31/2019.
 Orthopaedic surgeons (joint, spine, trauma, and
 pediatric); rheumatologists; engineers
 (biomedical, biomaterials, and biomechanical);
 experts in rehabilitation medicine, sports
 medicine, and connective tissue engineering; and
 biostatisticians.
Radiological Devices Panel of the Medical Devices   3............................  Immediately.
 Advisory Committee--Physicians with experience in  3............................  1/31/2019.
 general radiology, mammography, ultrasound,
 magnetic resonance, computed tomography, other
 radiological subspecialties and radiation
 oncology; scientists with experience in
 diagnostic devices, radiation physics,
 statistical analysis, digital imaging and image
 analysis.
----------------------------------------------------------------------------------------------------------------

I. General Description of the Committees Duties

A. Device Good Manufacturing Practice Advisory Committee

    The Committee reviews regulations proposed for promulgation
regarding good manufacturing practices governing the methods used in,
and the facilities and controls used for, the manufacture, packing,
storage, and installation of devices, and makes recommendations to the
Commissioner of Food and Drugs (the Commissioner) regarding the
feasibility and reasonableness of those proposed regulations. The
Committee also advises the Commissioner on any petition submitted by a
manufacturer for an exemption or variance from good manufacturing
practice regulations that is referred to the committee.

B. Medical Devices Advisory Committee

    The Committee reviews and evaluates data on the safety and
effectiveness of marketed and investigational devices and makes
recommendations for their regulation. The panels engage in a number of
activities to fulfill the functions the Federal Food, Drug, and
Cosmetic Act (FD&C Act) envisions for device advisory panels. With the
exception of the Medical Devices

Dispute Resolution Panel, each panel, according to its specialty area,
performs the following duties: (1) Advises the Commissioner regarding
recommended classification or reclassification of devices into one of
three regulatory categories, (2) advises on any possible risks to
health associated with the use of devices, (3) advises on formulation
of product development protocols, (4) reviews premarket approval
applications for medical devices, (5) reviews guidelines and guidance
documents, (6) recommends exemption of certain devices from the
application of portions of the FD&C Act, (7) advises on the necessity
to ban a device, and (8) responds to requests from the Agency to review
and make recommendations on specific issues or problems concerning the
safety and effectiveness of devices. With the exception of the Medical
Devices Dispute Resolution Panel, each panel, according to its
specialty area, may also make appropriate recommendations to the
Commissioner on issues relating to the design of clinical studies
regarding the safety and effectiveness of marketed and investigational
devices.
    The Dental Products Panel also functions at times as a dental drug
panel. The functions of the dental drug panel are to evaluate and
recommend whether various prescription drug products should be changed
to over-the-counter status and to evaluate data and make
recommendations concerning the approval of new dental drug products for
human use.
    The Medical Devices Dispute Resolution Panel provides advice to the
Commissioner on complex or contested scientific issues between FDA and
medical device sponsors, applicants, or manufacturers relating to
specific products, marketing applications, regulatory decisions and
actions by FDA, and Agency guidance and policies. The panel makes
recommendations on issues that are lacking resolution, are highly
complex in nature, or result from challenges to regular advisory panel
proceedings or Agency decisions or actions.

II. Criteria for Voting Members

A. Device Good Manufacturing Practice Advisory Committee

    The Committee consists of a core of nine members including the
Chair. Members and the Chair are selected by the Secretary of Health
and Human Services. Persons nominated for membership as a health
professional or officer or employee of any Federal, State, or local
government should have knowledge of or expertise in any one or more of
the following areas: Quality assurance concerning the design,
manufacture, and use of medical devices. To be eligible for selection
as a representative of the general public, nominees should possess
appropriate qualifications to understand and contribute to the
committee's work. Three of the members shall be officers or employees
of any State or local government or of the Federal Government; two
shall be representative of the interests of the device manufacturing
industry; two shall be representatives of the interests of physicians
and other health professionals; and two shall be representatives of the
interests of the general public. Almost all non-Federal members of this
committee serves as Special Government Employees. Members are invited
to serve for overlapping terms of 4 years. The particular needs at this
time for this committee are listed in table 2 of this document.

B. Panels of the Medical Devices Advisory Committee

    The Medical Devices Advisory Committee (MDAC) with its 18 panels
shall consist of a maximum of 159 standing members. Members are
selected by the Commissioner or designee from among authorities in
clinical and administrative medicine, engineering, biological and
physical sciences, and other related professions. Almost all non-
Federal members of this committee serve as Special Government
Employees. A maximum of 122 members shall be standing voting members
and 37 shall be nonvoting members who serve as representatives of
consumer interests and of industry interests. FDA is publishing
separate documents announcing the Request for Nominations Notification
for Non-Voting Representatives on certain panels of the MDAC. Persons
nominated for membership on the panels should have adequately
diversified experience appropriate to the work of the panel in such
fields as clinical and administrative medicine, engineering, biological
and physical sciences, statistics, and other related professions. The
nature of specialized training and experience necessary to qualify the
nominee as an expert suitable for appointment may include experience in
medical practice, teaching, and/or research relevant to the field of
activity of the panel. The particular needs at this time for each panel
are listed in table 2. Members will be invited to serve for terms of up
to 4 years.

III. Nomination Procedures

    Any interested person may nominate one or more qualified
individuals for membership on one or more of the advisory panels or
advisory committees. Self-nominations are also accepted. Nominations
must include a current, complete resume or curriculum vitae for each
nominee, including current business address, telephone number, and
email address if available and a signed copy of the Acknowledgement and
Consent form available at the FDA Advisory Nomination Portal (see
ADDRESSES). Nominations must also specify the advisory committee(s) for
which the nominee is recommended. Nominations must also acknowledge
that the nominee is aware of the nomination unless self-nominated. FDA
will ask potential candidates to provide detailed information
concerning such matters related to financial holdings, employment, and
research grants and/or contracts to permit evaluation of possible
sources of conflict of interest.
    This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

    Dated: August 17, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-18216 Filed 8-22-18; 8:45 am]
BILLING CODE 4164-01-P