12073 Federal Register / Vol. 68, No. 49 / Thursday, March 13, 2003 / Notices 7. Budget ( Please provide with a narrative explanation for the following categories): a. Personnel. b. Fringe Benefits. c. Contractual Costs. d. Travel. e. Equipment. f. Supplies. g. Other. h. Total Direct Costs ( add a   g). i. Total Indirect Costs ( must include documentation of accepted indirect rate). j. Total Cost ( add h and i). Costs proposed in the budget must be linked directly to the proposal. For example, if there is travel in connection with recruiting efforts, the budget should reflect travel costs. 8. Attach a one page resume for key personnel conducting the project.

IX. Where and When To Submit Please submit intents to apply by March 28, 2003 Intents to Apply must be e mailed, faxed, or mailed to the Project Officer, Linda Zarow. If Intents to Apply are mailed, they must be received by March 28, 2003. Only those submitting an `` Intent to Apply'' will be given the conference call in number for pre application assistance ( please see section X `` Pre application Assistance''). Send `` Intents to Apply'' to: Linda Zarow, Ariel Rios Building, 1200 Pennsylvania Ave., Washington, DC 20004; mail code 6101A; Rm 5433; fax: ( 202) 501   1004; email: zarow. linda@ epa. gov. Please include organization name, contact, and phone number. Please submit proposals by April 29, 2003 ( Remember, the Intent to Apply is not required and will have no bearing on the judging process, we recommend it for the benefit of our planning process only.) Please submit an original and three copies of the proposal. Submission of the Intent to Apply does not commit the applicant to submit a proposal. Submission of an Intent to Apply or a proposal does not guarantee funding. Electronic proposals will be accepted.

X. Pre Application Assistance To ensure that every interested party has equal opportunity to gain any needed additional administrative information useful to the application process, the Office of Air and Radiation has scheduled one conference call. The call will take place on April 10, 2003 from 10 AM to 12 PM EST. A call in number will provided to those who submit an Intent to Apply. Questions and answers from this conference call will be summarized and posted on OAR's web site. The web site address will be available at the pre application assistance conference. Federal rules protecting applicants' equal access to information prohibit any other contact that would result in information given to some but not all applicants. Therefore, as much as it desires to encourage all interested applicants, EPA can give no other assistance prior to final submission of applications. Requests for information outside the context of this conference call cannot be answered. The content of the call is entirely dependent upon questions asked.

XI. Notification of Proposal Receipt If the applicant includes a stamped, self addressed postcard along with proposal, the applicant will be notified of proposal receipt.

XII. Notification of Unsuccessful Offerors The Office of Air and Radiation will notify all unsuccessful offerors no later than 60 days after notifying the selected applicant.

XIII. Completed Application Packages Completed application package: Applies only to the selected applicant. The selected applicant will be contacted by the Project Officer and will be requested to submit a complete application. Instruction on how to obtain an application tool kit will be provided at that time. The application must be postmarked or received by regular or express mail on or before midnight May 30, 2003. Please provide an original and six copies. Electronic applications will be accepted. The application package should be submitted to Linda Zarow at: Ariel Rios Building, 1200 Pennsylvania Ave. Rm. 5433, Washington DC 20004; mail code 6101A. Courier or personally delivered applications must be brought to the same address.

XIV. Executive Order 12372 The applicant selected for funding will be required to provide a copy of the proposal to their designated State Point of Contact for review, pursuant with Executive Order 12372. This review is not required of initial proposals; only to the selected applicant.

XV. Award Date Subject to the availability of funding, awards should be made by August 1, 2003 for placement in the summer term 2004.

XVI. Dispute Resolution Process The Agency will resolve any disputes arising from this solicitation pursuant to the procedures outlined at 40 CFR 30.63 and § 31.70, subpart F.

XVII. Applicable Regulations and OMB Circulars The applicant selected will abide by 40 CFR part 30, OMB Circular A   122, and OMB Circular A   133.

XVIII. Confidential Business Information If any portion of an applicant's proposal is comprised of confidential business information ( CBI), appropriate pages should be so marked at the top of each page.

FOR FURTHER INFORMATION CONTACT: Linda Zarow, USEPA, Office of Air and Radiation, Immediate Office, Ariel Rios Building, 1200 Pennsylvania Avenue, NW., Washington, DC 20004, Mail Code 6101A, Rm 5433. Telephone ( 202) 564   7431; Fax ( 202) 501   1004; or e mail: zarow. linda@ epa. gov.

Dated: March 7, 2003. Elizabeth Craig, Deputy Assistant Administrator, Office of Air and Radiation. [ FR Doc. 03   6107 Filed 3   12   03; 8: 45 am]

BILLING CODE 6560   50   P ENVIRONMENTAL PROTECTION AGENCY [ OPP   2002   0353; FRL   7286   3]

Experimental Use Permit; Receipt of Applications AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: This notice announces receipt of applications 68467   EUP   3, 68467   EUP   5, 68467   EUP   T, 68467   EUP   I, 29964   EUP   1, 29964   EUP   3, 29964   EUP   U, and 29964   EUP   L from Mycogen Seeds/ Dow Agrosciences LLC and Pioneer Hi Bred International requesting experimental use permits ( EUPs) and EUP amendments for 1) Bacillus thuringiensis Cry34/ 35Ab1 protein and the genetic material necessary for its production ( from the insert of plasmid PHP 14352) in corn, 2) Bacillus thuringiensis Cry34/ 35Ab1 protein and the genetic material necessary for its production ( from the insert of plasmid PHP 12560) in corn, 3) Bacillus thuringiensis Cry34/ 35Ab1 protein and the genetic material necessary for its production ( from the insert of plasmid PHP 17662) in corn, and 4) Bacillus thuringiensis Cry34/ 35Ab1 protein and the genetic material necessary for its production ( from the insert of plasmid PHP 17658) in corn.

VerDate Jan< 31> 2003 17: 10 Mar 12, 2003 Jkt 200001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 13MRN1. SGM 13MRN1 12074 Federal Register / Vol. 68, No. 49 / Thursday, March 13, 2003 / Notices The Agency has determined that the applications may be of regional and national significance. Therefore, in accordance with 40 CFR 172.11( a), the Agency is soliciting comments on these applications. DATES: Comments, identified by docket ID number OPP   2002   0353, must be received on or before April 14, 2003. ADDRESSES: Comments may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Mike Mendelsohn, Biopesticides and Pollution Prevention Division ( 7511C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 308   8715; e mail address: mendelsohn. mike@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me?

This action is directed to the public in general. This action may, however, be of interest to those persons who are interested in agricultural biotechnology or may be required to conduct testing of chemical substances under the Federal Food, Drug, and Cosmetic Act ( FFDCA), or the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA). Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

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

1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP   2002   0353. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305   5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once in the system, select `` search,'' then key in the appropriate docket ID number. Certain types of information will not be placed in the EPA Dockets. Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket. EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket. To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket. When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket. For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket. The entire printed comment, including the copyrighted material, will be available in the public docket. Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket. Public comments that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket. Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff.

C. How and To Whom Do I Submit Comments? You may submit comments electronically, by mail, or through hand delivery/ courier. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment. Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked `` late.'' EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I. D. Do not use EPA Dockets or e mail to submit CBI or information protected by statute. 1. Electronically. If you submit an electronic comment as prescribed in this unit, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment. Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. i. EPA Dockets. Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments. Go directly to EPA Dockets at http:// www. epa. gov/ edocket, and VerDate Jan< 31> 2003 17: 10 Mar 12, 2003 Jkt 200001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 13MRN1. SGM 13MRN1 12075 Federal Register / Vol. 68, No. 49 / Thursday, March 13, 2003 / Notices follow the online instructions for submitting comments. Once in the system, select `` search,'' and then key in docket ID number OPP   2002   0353. The system is an `` anonymous access'' system, which means EPA will not know your identity, e mail address, or other contact information unless you provide it in the body of your comment. ii. E mail. Comments may be sent by e mail to opp docket@ epa. gov, Attention: Docket ID Number OPP   2002   0353. In contrast to EPA's electronic public docket, EPA's e mail system is not an `` anonymous access'' system. If you send an e mail comment directly to the docket without going through EPA's electronic public docket, EPA's e mail system automatically captures your e mail address. E mail addresses that are automatically captured by EPA's e mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. iii. Disk or CD ROM. You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit I. C. 2. These electronic submissions will be accepted in WordPerfect or ASCII file format. Avoid the use of special characters and any form of encryption. 2. By mail. Send your comments to: Public Information and Records Integrity Branch ( PIRIB), Office of Pesticide Programs ( OPP), Environmental Protection Agency ( 7502C), 1200 Pennsylvania Ave., NW., Washington, DC, 20460   0001, Attention: Docket ID Number OPP   2002   0353. 3. By hand delivery or courier. Deliver your comments to: Public Information and Records Integrity Branch ( PIRIB), Office of Pesticide Programs ( OPP), Environmental Protection Agency, Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket ID Number OPP   2002   0353. Such deliveries are only accepted during the docket's normal hours of operation as identified in Unit I. B. 1.

D. How Should I Submit CBI To the Agency? Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e mail. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI ( if you submit CBI on disk or CD ROM, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is CBI). Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person listed under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

You may find the following suggestions helpful for preparing your comments: 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/ or data you used that support your views. 4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide. 5. Provide specific examples to illustrate your concerns. 6. Offer alternative ways to improve the notice. 7. Make sure to submit your comments by the deadline in this document. 8. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

II. Background Both Mycogen Seeds/ Dow AgroSciences LLC and Pioneer Hi Bred International have applied to amend EUPs 68467   EUP   3, 68467   EUP   5, 29964   EUP   1, and 29964   EUP   3 for Bacillus thuringiensis Cry34/ 35Ab1 protein and the genetic material necessary for its production ( from the insert of plasmid PHP 14352) in corn and Bacillus thuringiensis Cry34/ 35Ab1 protein and the genetic material necessary for its production ( from the insert of plasmid PHP 12560) in corn to allow plant material grown under these EUPs to be used for food and/ or feed. The original notice of approval for these EUPs published in the Federal Register on February 20, 2002 ( 67 FR 7688) ( FRL   6820   3). Under the original notice, the Cry34/ 35Ab1 proteins were described as 149B1 protein since they had not yet received their Bacillus thuringiensis Pesticidal Crystal Proteins Nomenclature designation, http:// www. biols. susx. ac. uk/ home/ Neil_ Crickmore/ Bt/. These proteins have now been designated as Cry34Ab1 and Cry35Ab1 by the Bacillus thuringiensis Pesticidal Crystal Proteins Nomenclature Committee, a nongovernmental scientific committee. Mycogen Seeds/ Dow AgroSciences LLC and Pioneer Hi Bred International have also applied for EUPs involving Bacillus thuringiensis Cry34/ 35Ab1 protein and the genetic material necessary for its production ( from the insert of plasmid PHP 17662) in corn, and Bacillus thuringiensis Cry34/ 35Ab1 protein and the genetic material necessary for its production ( from the insert of plasmid PHP 17658) in corn. These EUPs have been proposed as noncrop destruct. For Mycogen Seeds/ Dow AgroSciences LLC, 394 acres each are proposed under 68467   EUP   I and 68467   EUP   T for testing in Colorado, Hawaii, Illinois, Indiana, Iowa, Kansas, Michigan, Minnesota, Missouri, Nebraska, North Dakota, Ohio, Puerto Rico, South Dakota, Texas, and Wisconsin. Testing is to include maize breeding and observation nursery, maize agronomic observation, herbicide tolerance, maize efficacy, insect resistance management, and maize demonstration trials. For Pioneer Hi Bred International, 623 acres are proposed under 29964   EUP   U and 624 acres are proposed under 29964   EUP   L for testing in California, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Michigan, Minnesota, Missouri, Nebraska, North Dakota, Ohio, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, and Wisconsin. Testing is to include insect resistance management, maize agronomic observation, maize breeding and observation nursery, maize demonstration, maize efficacy, maize hybrid production plots, maize regulatory field studies, non target organism, and herbicide tolerance trials.

III. What Action is the Agency Taking?

Following the review of the Mycogen Seeds/ Dow Agrosciences LLC and Pioneer Hi Bred International's applications and any comments and data received in response to this notice, EPA will decide whether to issue or deny these EUP requests. Any issuance of EUPs will be announced in the Federal Register.

VerDate Jan< 31> 2003 17: 10 Mar 12, 2003 Jkt 200001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 13MRN1. SGM 13MRN1 12076 Federal Register / Vol. 68, No. 49 / Thursday, March 13, 2003 / Notices IV. What is the Agency's Authority for Taking This Action?

The specific legal authority for EPA to take this action is under FIFRA section 5.

List of Subjects Environmental protection, Experimental use permits.

Dated: March 5, 2003. Janet L. Andersen, Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs.

[ FR Doc. 03   6187 Filed 3   11   03; 2: 49 pm]

BILLING CODE 6560   50   S EXPORT IMPORT BANK OF THE UNITED STATES Notice of Open Special Meeting of the Advisory Committee of the Export Import Bank of the United States ( Ex Im Bank).

SUMMARY: The Advisory Committee was established by Public Law 98   181, November 30, 1983, to advise the Export Import Bank on its programs and to provide comments for inclusion in the reports of the Export Import Bank of the United States to Congress. Time and Place: Monday, March 24, 2002, at 9: 30 a. m. to 12: 30 p. m. The meeting will be held at Ex Im Bank in Room 1143, 811 Vermont Avenue, NW., Washington, DC 20571. Agenda: Agenda items include an introduction of Advisory Committee responsibilities, a legislative update, introduction of topics for the year, and discussion of the Advisory Committee's recommendations to Ex Im Bank. Public Participation: The meeting will be open to public participation, and the last 10 minutes will be set aside for oral questions or comments. Members of the public may also file written statement( s) before or after the meeting. If any person wishes auxiliary aids ( such as a sign language interpreter) or other special accommodations, please contact, prior to March 17, 2003, Michele Kuester, Room 1243, 811 Vermont Avenue, NW., Washington, DC 20571, Voice: ( 202) 565   3766 or TDD ( 202) 565   3377. FOR FURTHER INFORMATION CONTACT: Michele Kuester, Room 1243, 811 Vermont Ave., NW., Washington, DC 20571, ( 202) 565   3766.

Peter Saba, General Counsel. [ FR Doc. 03   6054 Filed 3   12   03; 8: 45 am]

BILLING CODE 6690   01   M FEDERAL ELECTION COMMISSION Sunshine Act; Notice of Meeting * * * * * Previously Announced Date and Time: Thursday, February 27, 2003, meeting open to the public. This meeting was cancelled. * * * * * Previously Announced Date and Time: Thursday, March 6, 2003: The following item has been added to the agenda: Administrative fines   final rules and explanation and justification. * * * * * Previously Announced Date and Time: Friday, March 14, 2003, meeting open to the public. This meeting was cancelled. * * * * * Date and Time: Tuesday, March 18, 2003, at 10 a. m. Place: 999 E Street, NW., Washington, DC. Status: This meeting will be closed to the public. Items to be Discussed: Compliance matters pursuant to 2 U. S. C. 437g. Audits conducted pursuant to 2 U. S. C. 437g, 438( b), and title 26, U. S. C. Matters concerning participation in civil actions or proceedings or arbitration. Internal personnel rules and procedures or matters affecting a particular employee. * * * * * Date and Time: Thursday, March 20, 2003, at 10 a. m. Place: 999 E Street, NW., Washington, DC. ( ninth floor). Status: This meeting will be open to the public. Items to be Discussed: Correction and approval of minutes. Notice of proposed rulemaking on public funding of Presidential primary and general election candidates and conventions. Administrative matters. Person to Contact for Information: Mr. Ron Harris, Press Officer, Telephone: ( 202) 694   1220.

Mary W. Dove, Secretary of the Commission. [ FR Doc. 03   6175 Filed 3   11   03; 2: 36 pm]

BILLING CODE 6715   01   M FEDERAL TRADE COMMISSION Granting of Request for Early Termination of the Waiting Period Under the Premerger Notification Rules Section 7A of the Clayton Act, 15 U. S. C. 18a, as added by title II of the Hart Scott Rodino Antitrust Improvements Act of 1976, requires persons contemplating certain mergers or acquisitions to give the Federal Trade Commission and the Assistant Attorney General advance notice and to wait designated periods before consummation of such plans. Section 7A( b)( 2) of the Act permits the agencies, in individual cases, to terminate this waiting period prior to its expiration and requires that notice of this action be published in the Federal Register. The following transactions were granted early termination of the waiting period provided by law and the premerger notification rules. The grants were made by the Federal Trade Commission and the Assistant Attorney General for the Antitrust Division of the Department of Justice. Neither agency intends to take any action with respect to these proposed acquisitions during the applicable waiting period.

Trans # Acquiring Acquired Entities Transactions Granted Early Termination   12/ 30/ 2002 20030207 ............... Albert G. Lowenthal ..................... Canadian Imperial Bank of Commerce Canadian Imperial Bank of Commerce.

20030212 ............... General Motors Corporation ........ DaimlerChrysler AG ..................... New Venture Gear of Indiana, LLC. 20030215 ............... The Dun & Bradstreet Corporation Hoover's, Inc ................................ Hoover's, Inc.

20030225 ............... Blackstone Capital Partners IV Merchant Banking Fund L. P. Northrop Grumman Corporation .. Automotive Holdings Corp.

20030230 ............... Barry Diller ................................... Entertainment Publications, Inc ... Entertainment Publications, Inc. 20030231 ............... AmerisourceBergen Corporation Whitney V, L. P ............................. US Bioservices Corporation. 20030233 ............... MDU Resources Group, Inc ........ PG& E Corporation ....................... Mountain View Power Partners, LLC.

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[Federal Register: October 6, 2008 (Volume 73, Number 194)]
[Notices]
[Page 58292-58293]
[DOCID:fr06oc08-143]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

[DOT-0ST-2008-0296]

Notice of Rights and Protections Available Under the Federal
Antidiscrimination and Whistleblower Protection Laws

AGENCY: Office of the Secretary.

ACTION: No FEAR Act Notice.

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SUMMARY: This Notice implements Title II of the Notification and
Federal Employee Antidiscrimination and Retaliation Act of 2002
concerning the annual obligation of Federal agencies to notify all
employees, former employees, and applicants for Federal employment of
the rights and protections available to them under the Federal
Antidiscrimination Laws and Whistleblower Protection Laws.

FOR FURTHER INFORMATION CONTACT: Caffin Gordon, Associate Director of
Policy and Quality Control Division, S-35, Departmental Office of Civil
Rights, Office of the Secretary, U.S. Department of Transportation,
1200 New Jersey Avenue, SE., Washington, DC 20590,<PHONE_NUMBER> or
(TTY)<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Electronic Access

    You may retrieve this document online through the Federal Document
Management System (FDMS) at: http://www.regulations.gov. The FDMS is
available 24 hours each day, 365 days each year. Electronic retrieval
help and guidelines are available under the help section of the Web
site. An electronic

copy of this document may be downloaded by using a computer, modem and
suitable communications software from the Government Printing Office's
Electronic Bulletin Board home page at: http://www.nara.gov/fedreg and
the Government Printing Office's Web page at: http://
www.access.gpo.gov/nara.

No Fear Act Notice

    On May 15, 2002, Congress enacted the ``Notification and Federal
Employee Antidiscrimination and Retaliation Act of 2002,'' Public Law
107-174, which is now known as the No FEAR Act. One purpose of the Act
is to ``require that Federal agencies be accountable for violations of
antidiscrimination and whistleblower protection laws.'' In support of
this purpose, Congress found that ``agencies cannot be run effectively
if those agencies practice or tolerate discrimination.'' The Act also
requires this agency to provide this notice to Federal employees,
former Federal employees and applicants for Federal employment to
inform you of the rights and protections available to you under Federal
antidiscrimination, whistleblower protection and retaliation laws.

Antidiscrimination Laws

    A Federal agency cannot discriminate against an employee or
applicant with respect to the terms, conditions or privileges of
employment on the basis of race, color, religion, sex, national origin,
age, disability, marital status or political affiliation.
Discrimination on these bases is prohibited by one or more of the
following statutes: 5 U.S.C. 2302(b)(1), 29 U.S.C. 206(d), 29 U.S.C.
631, 29 U.S.C. 633a, 29 U.S.C. 791 and 42 U.S.C. 2000e-16.
    If you believe that you have been the victim of unlawful
discrimination on the basis of race, color, religion, sex, national
origin or disability, you must contact an Equal Employment Opportunity
(EEO) counselor within 45 calendar days of the alleged discriminatory
action, or, in the case of a personnel action, within 45 calendar days
of the effective date of the action, before you can file a formal
complaint of discrimination with your agency. See, e.g., 29 CFR 1614.
If you believe that you have been the victim of unlawful discrimination
on the basis of age, you must either contact an EEO counselor as noted
above or give notice of intent to sue to the Equal Employment
Opportunity Commission (EEOC) within 180 days of the alleged
discriminatory action. If you are alleging discrimination based on
marital status or political affiliation, you may file a written
complaint with the U.S. Office of Special Counsel (OSC) (see contact
information below). In the alternative (or in some cases, in addition),
you may pursue a discrimination complaint by filing a grievance through
your agency's administrative or negotiated grievance procedures, if
such procedures apply and are available.

Whistleblower Protection Laws

    A Federal employee with authority to take, direct others to take,
recommend or approve any personnel action must not use that authority
to take or fail to take, or threaten to take or fail to take, a
personnel action against an employee or applicant because of disclosure
of information by that individual that is reasonably believed to
evidence violations of law, rule or regulation; gross mismanagement;
gross waste of funds; an abuse of authority; or a substantial and
specific danger to public health or safety, unless disclosure of such
information is specifically prohibited by law and such information is
specifically required by Executive order to be kept secret in the
interest of national defense or the conduct of foreign affairs.
Retaliation against an employee or applicant for making a protected
disclosure is prohibited by 5 U.S.C. 2302(b)(8). If you believe that
you have been the victim of whistleblower retaliation, you may file a
written complaint (Form OSC-11) with the U.S. Office of Special Counsel
at 1730 M Street NW., Suite 218, Washington, DC 20036-4505 or online
through the OSC Web site--http://www.osc.gov.

Retaliation for Engaging in Protected Activity

    A Federal agency cannot retaliate against an employee or applicant
because that individual exercises his or her rights under any of the
Federal antidiscrimination or whistleblower protections laws listed
above. If you believe that you are the victim of retaliation for
engaging in protected activity, you must follow, as appropriate, the
procedures described in the Antidiscrimination Laws and Whistleblower
Protection Laws sections or, if applicable, the administrative or
negotiated grievance procedures in order to pursue any legal remedy.

Disciplinary Actions

    Under the existing laws, each agency retains the right, where
appropriate, to discipline a Federal employee who has engaged in
discriminatory or retaliatory conduct, up to and including removal. If
OSC has initiated an investigation under 5 U.S.C. 1214, however,
according to 5 U.S.C. 1214(f), agencies must seek approval from the
Special Counsel to discipline employees for, among other activities,
engaging in prohibited retaliation. Nothing in the No FEAR Act alters
existing laws or permits an agency to take unfounded disciplinary
action against a Federal employee or to violate the procedural rights
of a Federal employee who has been accused of discrimination.

Additional Information

    For further information regarding the No FEAR Act regulations,
refer to 5 CFR 724, as well as the appropriate offices within your
agency (e.g., EEO/civil rights office, human resources office or legal
office). Additional information regarding Federal antidiscrimination,
whistleblower protection and retaliation laws can be found at the EEOC
Web site--http://www.eeoc.gov and the OSC Web site--http://www.osc.gov.

Existing Rights Unchanged

    Pursuant to section 205 of the No FEAR Act, neither the Act nor
this notice creates, expands or reduces any rights otherwise available
to any employee, former employee or applicant under the laws of the
United States, including the provisions of law specified in 5 U.S.C.
2302(d).

    Issued in Washington, DC on September 29, 2008.
J. Michael Trujillo,
Director, Departmental Office of Civil Rights, United States Department
of Transportation.
[FR Doc. E8-23592 Filed 10-3-08; 8:45 am]

BILLING CODE 4910-9X-P


[Federal Register Volume 81, Number 79 (Monday, April 25, 2016)]
[Notices]
[Pages 24132-24133]
[FR Doc No: 2016-09503]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2010-0046]

QPS Evaluation Services: Grant of Expansion of Recognition

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

ACTION: Notice.

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SUMMARY: In this notice, OSHA announces its final decision to expand
the scope of recognition for QPS Evaluation Services Inc. as a
Nationally Recognized Testing Laboratory (NRTL).

DATES: The expansion of the scope of recognition becomes effective on
April 25, 2016.

FOR FURTHER INFORMATION CONTACT: Information regarding this notice is
available from the following sources:
    Press inquiries: Contact Mr. Frank Meilinger, Director, OSHA Office
of Communications, U.S. Department of Labor, 200 Constitution Avenue
NW., Room N-3647, Washington, DC 20210; telephone:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    General and technical information: Contact Mr. Kevin Robinson,
Director, Office of Technical Programs and Coordination Activities,
Directorate of Technical Support and Emergency Management, Occupational
Safety and Health Administration, U.S. Department of Labor, 200
Constitution Avenue NW., Room N-3655, Washington, DC 20210; telephone:
(202) 693-2110; email<EMAIL_ADDRESS>OSHA's Web page includes
information about the NRTL Program (see http://www.osha.gov/dts/otpca/nrtl/index.html).

SUPPLEMENTARY INFORMATION:

I. Notice of Final Decision

    OSHA hereby gives notice of the expansion of the scope of
recognition of QPS Evaluation Services Inc. (QPS) as an NRTL. QPS's
expansion covers the addition of one test standard to its scope of
recognition.
    OSHA recognition of an NRTL signifies that the organization meets
the requirements specified by 29 CFR 1910.7. Recognition is an
acknowledgment that the organization can perform independent safety
testing and certification of the specific products covered within its
scope of recognition and is not a delegation or grant of government
authority. As a result of recognition, employers may use products
properly approved by the NRTL to meet OSHA standards that

require testing and certification of the products.
    The Agency processes applications by an NRTL for initial
recognition, or for expansion or renewal of this recognition, following
requirements in Appendix A to 29 CFR 1910.7. This appendix requires
that the Agency publish two notices in the Federal Register in
processing an application. In the first notice, OSHA announces the
application and provides its preliminary finding and, in the second
notice, the Agency provides its final decision on the application.
These notices set forth the NRTL's scope of recognition or
modifications of that scope. OSHA maintains an informational Web page
for each NRTL that details its scope of recognition. These pages are
available from the Agency's Web site at http://www.osha.gov/dts/otpca/nrtl/index.html.
    QPS submitted an application, dated July 28, 2014, (OSHA-2010-0046-
0005) to expand its recognition to include one additional test
standard. OSHA staff performed a detailed analysis of the application
packet and reviewed other pertinent information. OSHA performed an on-
site review in relation to this application on July 16-17, 2015.
    OSHA published the preliminary notice announcing QPS's expansion
application in the Federal Register on January 22, 2016 (81 FR 3832).
The Agency requested comments by February 8, 2016, but it received no
comments in response to this notice. OSHA now is proceeding with this
final notice to grant expansion of QPS's scope of recognition.
    To obtain or review copies of all public documents pertaining to
QPS's application, go to www.regulations.gov or contact the Docket
Office, Occupational Safety and Health Administration, U.S. Department
of Labor, 200 Constitution Avenue NW., Room N-2625, Washington, DC
20210. Docket No. OSHA-2010-0046 contains all materials in the record
concerning QPS's recognition.

II. Final Decision and Order

    OSHA staff examined QPS's expansion application, its capability to
meet the requirements of the test standards, and other pertinent
information. Based on its review of this evidence, OSHA finds that QPS
meets the requirements of 29 CFR 1910.7 for expansion of its
recognition, subject to the specified limitation and conditions listed
below. OSHA, therefore, is proceeding with this final notice to grant
QPS's scope of recognition. OSHA limits the expansion of QPS's
recognition to testing and certification of products for demonstration
of conformance to the test standard listed in Table 1 below.

 Table 1--List of Appropriate Test Standard for Inclusion in QPS's NRTL
                          Scope of Recognition
------------------------------------------------------------------------
           Test standard                     Test standard title
------------------------------------------------------------------------
ANSI/AAMI ES 60601-1: 2005/(R)2012  Medical Electrical Equipment--Part
                                     1: General Requirements for Basic
                                     Safety and Essential Performance.
------------------------------------------------------------------------

    OSHA's recognition of any NRTL for a particular test standard is
limited to equipment or materials for which OSHA standards require
third-party testing and certification before using them in the
workplace. Consequently, if a test standard also covers any products
for which OSHA does not require such testing and certification, an
NRTL's scope of recognition does not include these products.

A. Conditions

    In addition to those conditions already required by 29 CFR 1910.7,
QPS must abide by the following conditions of the recognition:
    1. QPS must inform OSHA as soon as possible, in writing, of any
change of ownership, facilities, or key personnel, and of any major
change in its operations as an NRTL, and provide details of the
change(s);
    2. QPS must meet all the terms of its recognition and comply with
all OSHA policies pertaining to this recognition; and
    3. QPS must continue to meet the requirements for recognition,
including all previously published conditions on QPS's scope of
recognition, in all areas for which it has recognition.
    Pursuant to the authority in 29 CFR 1910.7, OSHA hereby expands the
scope of recognition of QPS, subject to the limitation and conditions
specified above.

Authority and Signature

    David Michaels, Ph.D., MPH, Assistant Secretary of Labor for
Occupational Safety and Health, 200 Constitution Avenue NW.,
Washington, DC 20210, authorized the preparation of this notice.
Accordingly, the Agency is issuing this notice pursuant to 29 U.S.C.
657(g)(2), Secretary of Labor's Order No. 1-2012 (77 FR 3912, Jan. 25,
2012), and 29 CFR 1910.7.

    Signed at Washington, DC, on April 20, 2016.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2016-09503 Filed 4-22-16; 8:45 am]
 BILLING CODE 4510-26-P


[Federal Register Volume 79, Number 117 (Wednesday, June 18, 2014)]
[Rules and Regulations]
[Pages 34623-34625]
[FR Doc No: 2014-14216]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 872

[Docket No. FDA-2012-N-0677]

Dental Devices; Reclassification of Blade-Form Endosseous Dental
Implant

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a final
order to reclassify the blade-form endosseous dental implant, a
preamendments class III device, into class II (special controls). On
its own initiative, based on new information, FDA is revising the
classification of blade-form endosseous dental implants.

DATES: This order is effective July 18, 2014.

FOR FURTHER INFORMATION CONTACT: Michael J. Ryan, Center for Devices
and Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 1615,
Silver Spring, MD 20993,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background--Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended
by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L.
94-295), the Safe Medical Devices Act of 1990 (Pub. L. 101-629), the
Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L.
105-115), the Medical Device User Fee and Modernization Act of 2002
(Pub. L. 107-250), the Medical Devices Technical Corrections Act (Pub.
L. 108-214), the Food and Drug Administration Amendments Act of 2007
(Pub. L. 110-85), and the Food and Drug Administration Safety and
Innovation Act (FDASIA) (Pub. L. 112-144), among other amendments,
established a comprehensive system for the regulation of medical
devices intended for human use. Section 513 of the FD&C Act (21 U.S.C.
360c) established three categories (classes) of devices, reflecting the
regulatory controls needed to provide reasonable assurance of their
safety and effectiveness. The three categories of devices are class I
(general controls), class II (special controls), and class III
(premarket approval).
    Under section 513(d) of the FD&C Act, devices that were in
commercial distribution before the enactment of the 1976 amendments,
May 28, 1976 (generally referred to as preamendments devices), are
classified after FDA has: (1) Received a recommendation from a device
classification panel (an FDA advisory committee); (2) published the
panel's recommendation for comment, along with a proposed regulation
classifying the device; and (3) published a final regulation
classifying the device. FDA has classified most preamendments devices
under these procedures.
    Devices that were not in commercial distribution prior to May 28,
1976 (generally referred to as postamendments devices), are
automatically classified by section 513(f) of the FD&C Act into class
III without any FDA rulemaking process. Those devices remain in class
III and require premarket approval unless, and until, the device is
reclassified into class I or II or FDA issues an order finding the
device to be substantially equivalent, in accordance with section
513(i) of the FD&C Act, to a predicate device that does not require
premarket approval. The Agency determines whether new devices are
substantially equivalent to predicate devices by means of premarket
notification procedures in section 510(k) of the FD&C Act (21 U.S.C.
360(k)) and 21 CFR part 807.
    A preamendments device that has been classified into class III may
be marketed by means of premarket notification procedures (510(k)
process) without submission of a premarket approval application (PMA)
until FDA issues a final order under section 515(b) of the FD&C Act (21
U.S.C. 360e(b)) requiring premarket approval or until the device is
subsequently reclassified into class I or class II.
    On July 9, 2012, FDASIA was enacted. Section 608(a) of FDASIA
amended section 513(e) of the FD&C Act, changing the mechanism for
reclassifying a device from rulemaking to an administrative order.
    Section 513(e) of the FD&C Act governs reclassification of
classified preamendments devices. This section provides that FDA may,
by administrative order, reclassify a device based upon ``new
information.'' FDA can initiate a reclassification under section 513(e)
of the FD&C Act or an interested person may petition FDA to reclassify
a preamendments device. The term ``new information,'' as used in
section 513(e) of the FD&C Act, includes information developed as a
result of a reevaluation of the data before the Agency when the device
was originally classified, as well as information not presented, not
available, or not developed at that time. (See, e.g., Holland-Rantos
Co. v. United States Department of Health, Education, and Welfare, 587
F.2d 1173, 1174 n.1 (D.C. Cir. 1978); Upjohn v. Finch, 422 F.2d 944
(6th Cir. 1970); Bell v. Goddard, 366 F.2d 177 (7th Cir. 1966).)
    Reevaluation of the data previously before the Agency is an
appropriate basis for subsequent action where the reevaluation is made
in light of newly available authority (see Bell, 366 F.2d at 181;
Ethicon, Inc. v. FDA, 762 F.Supp. 382, 388-391 (D.D.C. 1991)) or in
light of changes in ``medical science'' (Upjohn, 422 F.2d at 951).
Whether data before the Agency are old or new data, the ``new
information'' to support reclassification under section 513(e) of the
FD&C Act must be ``valid scientific evidence,'' as defined in section
513(a)(3) and 21 CFR 860.7(c)(2). (See, e.g., General Medical Co. v.
FDA, 770 F.2d 214 (D.C. Cir. 1985); Contact Lens Manufacturers
Association v. FDA, 766

F.2d 592 (D.C. Cir. 1985), cert. denied, 474 U.S. 1062 (1986).)
    FDA relies upon ``valid scientific evidence'' in the classification
process to determine the level of regulation for devices. To be
considered in the reclassification process, the ``valid scientific
evidence'' upon which the Agency relies must be publicly available.
Publicly available information excludes trade secret and/or
confidential commercial information, e.g., the contents of a pending
PMA. See section 520(c) of the FD&C Act (21 U.S.C. 360j(c)). Section
520(h)(4) of the FD&C Act, added by FDAMA, provides that FDA may use,
for reclassification of a device, certain information in a PMA 6 years
after the application has been approved. This includes information from
clinical and preclinical tests or studies that demonstrate the safety
or effectiveness of the device but does not include descriptions of
methods of manufacture or product composition and other trade secrets.
    Section 513(e)(1) of the FD&C Act sets forth the process for
issuing a final order. Specifically, prior to the issuance of a final
order reclassifying a device, the following must occur: (1) Publication
of a proposed order in the Federal Register; (2) a meeting of a device
classification panel described in section 513(b) of the FD&C Act; and
(3) consideration of comments to a public docket.

II. Regulatory History of the Device

    FDA published a proposed order to reclassify this device in the
Federal Register of January 14, 2013 (78 FR 2647) (the ``proposed
order''). As discussed in the proposed order, the Agency originally
issued a final rule classifying all endosseous dental implants (without
distinguishing based on geometry) into class III (52 FR 30082, August
12, 1987). After later consideration by a reclassification panel, root-
form endosseous dental implants were reclassified into class II in a
final rule issued on May 12, 2004 (69 FR 26302), but blade-form
endosseous dental implants remained in class III.
    After consideration of available information on blade-form
endosseous dental implants, the proposed order indicated that FDA
believed these devices could also be down classified to class II,
subject to the identified special controls. As required by section
513(e)(1) of the FD&C Act, on July 18, 2013, FDA also convened a
meeting of the Dental Products Panel (the Panel) to consider the
existing valid scientific evidence to support reclassification of
blade-form endosseous dental implants into class II.
    The Panel discussed and agreed that the risks to health for this
device were adequately captured as presented by FDA. The Panel
deliberations included discussion of whether the risk of bone loss is
higher for blade-form dental implants as compared to root-form dental
implant devices. The Panel also discussed the technique-sensitive
nature of this device and expressed a concern that additional training,
which may not be found in the current curriculum for dental schools, is
needed prior to the use of this device to address the identified risks
to health.
    The Panel agreed that the proposed special controls were reasonable
to mitigate the identified risks to health but recommended the device
labeling include specific patient selection criteria and
recommendations for training and education requirements for clinicians
using this device. The Panel recommended that companies marketing this
device ensure that device-specific training is available to clinicians.
The Panel also recommended clinical data as a special control for the
purpose of capturing failure rates and adverse event detection.
    The special controls as previously proposed by FDA included
documented clinical experience for effective use and observed adverse
events which addresses the recommendations for patient selection
criteria, and failure rate and adverse event detection. Additionally,
the special controls include patient labeling which must contain
instructions for reporting complications. The patient labeling will
also address the concern for failure rate and adverse event detection.
To address the Panel's concern related to recommendations for training
and education requirements, FDA has added a special control for the
device labeling to include qualifications and training requirements for
clinicians using this device.
    The Panel concluded that general controls alone are not sufficient
due to the identified risks to health; however, special controls, in
combination with the general controls, can be sufficient to assure the
safety and effectiveness of blade-form endosseous dental implants. The
Panel agreed that this device should be reclassified into class II
(special controls).

III. Public Comments in Response to the Proposed Order

    In response to the proposed order, FDA received two comments from
practicing clinicians. Both of the comments supported reclassification
of the devices into class II, and described positive clinical
experience regarding the safety and effectiveness of the device. FDA
agrees with the comments.

IV. The Final Order

    Under section 513(e) of the FD&C Act, FDA is adopting its findings
as published in the preamble to the proposed order. FDA is issuing this
final order to reclassify the blade-form endosseous dental implant from
class III to class II and to establish special controls. Following the
effective date of this final order, firms marketing blade-form
endosseous dental implants will need either to: (1) Comply with the
particular mitigation measures set forth in the special controls or (2)
use alternative mitigation measures, but demonstrate to the Agency's
satisfaction that those alternative measures identified by the firm
will provide at least an equivalent assurance of safety and
effectiveness.
    Section 510(m) of the FD&C Act provides that FDA may exempt a class
II device from the premarket notification requirements under section
510(k) of the FD&C Act if FDA determines that premarket notification is
not necessary to provide reasonable assurance of the safety and
effectiveness of the devices. FDA has determined that premarket
notification is necessary to provide reasonable assurance of safety and
effectiveness of blade-form endosseous implants; and therefore, this
device type is not exempt from premarket notification requirements.

V. Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

VI. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21
CFR part 812 have been approved under OMB control number 0910-0078; the
collections of information in 21 CFR part 807, subpart E, have been
approved under OMB control number 0910-0120; the collections of
information in 21 CFR part 814, subpart B, have been approved under OMB
control number 0910-0231;

and the collections of information under 21 CFR part 801 have been
approved under OMB control number 0910-0485.

VII. Codification of Orders

    Prior to the amendments by FDASIA, section 513(e) of the FD&C Act
provided for FDA to issue regulations to reclassify devices. Although
section 513(e) of the FD&C Act as amended requires FDA to issue final
orders rather than regulations, FDASIA also provides for FDA to revoke
previously issued regulations by order. FDA will continue to codify
classifications and reclassifications in the Code of Federal
Regulations (CFR). Changes resulting from final orders will appear in
the CFR as changes to codified classification determinations or as
newly codified orders. Therefore, under section 513(e)(1)(A)(i) of the
FD&C Act, as amended by FDASIA, in this final order, we are revoking
the requirements in 21 CFR 872.3640 related to the classification of
blade-form endosseous implants as class III devices and codifying the
reclassification of blade-form endosseous into class II.

List of Subjects in 21 CFR Part 872

    Medical devices.

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

PART 872--DENTAL DEVICES

0
1. The authority citation for 21 CFR part 872 continues to read as
follows:

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

0
2. Section 872.3640 is amended by revising paragraph (a) and (b)(2) to
read as follows:

Sec.  872.3640  Endosseous dental implant.

    (a) Identification. An endosseous dental implant is a prescription
device made of a material such as titanium or titanium alloy that is
intended to be surgically placed in the bone of the upper or lower jaw
arches to provide support for prosthetic devices, such as artificial
teeth, in order to restore a patient's chewing function.
    (b) * * *
    (2) Classification. Class II (special controls). The device is
classified as class II if it is a blade-form endosseous dental implant.
The special controls for this device are:
    (i) The design characteristics of the device must ensure that the
geometry and material composition are consistent with the intended use;
    (ii) Mechanical performance (fatigue) testing under simulated
physiological conditions to demonstrate maximum load (endurance limit)
when the device is subjected to compressive and shear loads;
    (iii) Corrosion testing under simulated physiological conditions to
demonstrate corrosion potential of each metal or alloy, couple
potential for an assembled dissimilar metal implant system, and
corrosion rate for an assembled dissimilar metal implant system;
    (iv) The device must be demonstrated to be biocompatible;
    (v) Sterility testing must demonstrate the sterility of the device;
    (vi) Performance testing to evaluate the compatibility of the
device in a magnetic resonance (MR) environment;
    (vii) Labeling must include a clear description of the
technological features, how the device should be used in patients,
detailed surgical protocol and restoration procedures, relevant
precautions and warnings based on the clinical use of the device, and
qualifications and training requirements for device users including
technicians and clinicians;
    (viii) Patient labeling must contain a description of how the
device works, how the device is placed, how the patient needs to care
for the implant, possible adverse events and how to report any
complications; and
    (ix) Documented clinical experience must demonstrate safe and
effective use and capture any adverse events observed during clinical
use.

    Dated: June 12, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-14216 Filed 6-17-14; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 39 (Wednesday, February 27, 2019)]
[Notices]
[Pages 6408-6409]
[FR Doc No: 2019-03376]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2019-0002; Internal Agency Docket No. FEMA-B-1906]

Proposed Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: Comments are requested on proposed flood hazard
determinations, which may include additions or modifications of any
Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area
(SFHA) boundary or zone designation, or regulatory floodway on the
Flood Insurance Rate Maps (FIRMs), and where applicable, in the
supporting Flood Insurance Study (FIS) reports for the communities
listed in the table below. The purpose of this notice is to seek
general information and comment regarding the preliminary FIRM, and
where applicable, the FIS report that the Federal Emergency Management
Agency (FEMA) has provided to the affected communities. The FIRM and
FIS report are the basis of the floodplain management measures that the
community is required either to adopt or to show evidence of having in
effect in order to qualify or remain qualified for participation in the
National Flood Insurance Program (NFIP). In addition, the FIRM and FIS
report, once effective, will be used by insurance agents and others to
calculate appropriate flood insurance premium rates for new buildings
and the contents of those buildings.

DATES: Comments are to be submitted on or before May 28, 2019.

ADDRESSES: The Preliminary FIRM, and where applicable, the FIS report
for each community are available for inspection at both the online
location https://www.fema.gov/preliminaryfloodhazarddata and the
respective Community Map Repository address listed in the tables below.
Additionally, the current effective FIRM and FIS report for each
community are accessible online through the FEMA Map Service Center at
https://msc.fema.gov for comparison.
    You may submit comments, identified by Docket No. FEMA-B-1906, to
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance
and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC
20472,<PHONE_NUMBER>, or (email<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>, or (email)
<EMAIL_ADDRESS>or visit the FEMA Map Information
eXchange (FMIX) online at https://www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: FEMA proposes to make flood hazard
determinations for each community listed below, in accordance with
section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C.
4104, and 44 CFR 67.4(a).
    These proposed flood hazard determinations, together with the
floodplain management criteria required by 44 CFR 60.3, are the minimum
that are required. They should not be construed to mean that the
community must change any existing ordinances that are more stringent
in their floodplain management requirements. The community may at any
time enact stricter requirements of its own or pursuant to policies
established by other Federal, State, or regional entities. These flood
hazard determinations are used to meet the floodplain management
requirements of the NFIP and are used to calculate the appropriate
flood insurance premium rates for new buildings built after the FIRM
and FIS report become effective.
    The communities affected by the flood hazard determinations are
provided in the tables below. Any request for reconsideration of the
revised flood hazard information shown on the Preliminary FIRM and FIS
report that satisfies the data requirements

outlined in 44 CFR 67.6(b) is considered an appeal. Comments unrelated
to the flood hazard determinations also will be considered before the
FIRM and FIS report become effective.
    Use of a Scientific Resolution Panel (SRP) is available to
communities in support of the appeal resolution process. SRPs are
independent panels of experts in hydrology, hydraulics, and other
pertinent sciences established to review conflicting scientific and
technical data and provide recommendations for resolution. Use of the
SRP only may be exercised after FEMA and local communities have been
engaged in a collaborative consultation process for at least 60 days
without a mutually acceptable resolution of an appeal. Additional
information regarding the SRP process can be found online at https://www.floodsrp.org/pdfs/srp_overview.pdf.
    The watersheds and/or communities affected are listed in the tables
below. The Preliminary FIRM, and where applicable, FIS report for each
community are available for inspection at both the online location
https://www.fema.gov/preliminaryfloodhazarddata and the respective
Community Map Repository address listed in the tables. For communities
with multiple ongoing Preliminary studies, the studies can be
identified by the unique project number and Preliminary FIRM date
listed in the tables. Additionally, the current effective FIRM and FIS
report for each community are accessible online through the FEMA Map
Service Center at https://msc.fema.gov for comparison.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

Michael M. Grimm,
Assistant Administrator for Risk Management, Department of Homeland
Security, Federal Emergency Management Agency.

------------------------------------------------------------------------
                                             Community map repository
               Community                             address
------------------------------------------------------------------------
                Floyd County, Iowa and Incorporated Areas
          Project: 16-07-2267S Preliminary Date: June 15, 2018
------------------------------------------------------------------------
City of Charles City...................  City Hall, 105 Milwaukee Mall,
                                          Charles City, IA 50616.
City of Floyd..........................  City Hall, 617 Monroe Street,
                                          Floyd, IA 50435.
City of Marble Rock....................  City Hall, 105 Main Street
                                          South, Marble Rock, IA 50653.
City of Nora Springs...................  City Hall, 45 North Hawkeye
                                          Avenue, Nora Springs, IA
                                          50458.
City of Rockford.......................  City Hall, 206 West Main
                                          Avenue, Rockford, IA 50468.
City of Rudd...........................  City Hall, 402 Chickasaw
                                          Street, Rudd, IA 50471.
Unincorporated Areas of Floyd County...  Floyd County Courthouse, 101
                                          South Main Street, Suite 206,
                                          Charles City, IA 50616.
------------------------------------------------------------------------
              Winnebago County, Iowa and Incorporated Areas
          Project: 16-07-2071S Preliminary Date: June 15, 2018
------------------------------------------------------------------------
City of Buffalo Center.................  City Hall, 201 2nd Avenue
                                          Southwest, Buffalo Center, IA
                                          50424.
City of Lake Mills.....................  City Hall, 105 West Main
                                          Street, Lake Mills, IA 50450.
City of Leland.........................  City Hall, 316 Walnut Street,
                                          Leland, IA 50453.
City of Rake...........................  Town Hall, 101 East Grace
                                          Street, Rake, IA 50465.
City of Scarville......................  City Hall, 121 Main Street,
                                          Scarville, IA 50473.
City of Thompson.......................  City Hall, 167 2nd Avenue West,
                                          Thompson, IA 50478.
Unincorporated Areas of Winnebago        Winnebago County Courthouse,
 County.                                  126 South Clark Street, Forest
                                          City, IA 50436.
------------------------------------------------------------------------
            Randolph County, Missouri and Incorporated Areas
          Project: 17-07-0185S Preliminary Date: July 13, 2018
------------------------------------------------------------------------
City of Clark..........................  City Hall, 401 Main Street,
                                          Clark, MO 65243.
City of Huntsville.....................  City Hall, 205 South Main
                                          Street, Huntsville, MO 65259.
City of Moberly........................  City Hall, 101 West Reed
                                          Street, Moberly, MO 65270.
Unincorporated Areas of Randolph County  Randolph County Courthouse, 372
                                          Highway JJ, Suite A,
                                          Huntsville, MO 65259.
Village of Cairo.......................  Village Hall, 202 West Martin
                                          Street, Cairo, MO 65239.
Village of Renick......................  Randolph County Courthouse, 372
                                          Highway JJ, Suite A,
                                          Huntsville, MO 65259.
------------------------------------------------------------------------

[FR Doc. 2019-03376 Filed 2-26-19; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register: January 15, 2008 (Volume 73, Number 10)]
[Notices]
[Page 2509]
[DOCID:fr15ja08-73]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Drug Safety and Risk Management Advisory Committee; Amendment of
Notice

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

    The Food and Drug Administration (FDA) is announcing an amendment
to the notice of meeting of the Drug Safety and Risk Management
Advisory Committee. This meeting was announced in the Federal Register
of December 11, 2007 (72 FR 70336). The amendment is being made to
reflect a change in the Agenda portion of the document. There are no
other changes.

FOR FURTHER INFORMATION CONTACT: Teresa A. Watkins, Center for Drug
Evaluation and Research (HFD-21), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, e-
mail<EMAIL_ADDRESS>or FDA Advisory Committee Information
Line, 1-800-741-8138<PHONE_NUMBER> in the Washington DC area), code
3014512535. Please call the Information Line for up-to-date information
on this meeting.

SUPPLEMENTARY INFORMATION: In the Federal Register of December 11,
2007, FDA announced that a meeting of the Drug Safety and Risk
Management Advisory Committee would be held on February 1, 2008. On
page 70336, in the second column, the first paragraph of the Agenda
portion of document is amended to read as follows:
    Agenda: The committee will discuss the efficacy and safety of new
drug application (NDA) 22-054, INJECTAFER (ferric carboxymaltose
injection), Luitpold Pharmaceuticals Inc., used for the treatment of
iron deficiency anemia in postpartum patients or iron deficiency anemia
in patients with heavy uterine bleeding.
    This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

    Dated: January 7, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-490 Filed 1-14-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 85, Number 7 (Friday, January 10, 2020)]
[Proposed Rules]
[Pages 1290-1292]
[FR Doc No: 2019-28469]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2019-1071; Product Identifier 2019-NM-165-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to adopt a new airworthiness directive (AD)
for all The Boeing Company Model 737-900ER series airplanes. This
proposed AD was prompted by reports of significant corrosion of
electrical connectors located in the main landing gear (MLG) wheel
well. This proposed AD would require repetitive records checks to
determine exposure to certain deicing fluids or repetitive inspections
for corrosion of the electrical connectors, and corrective actions if
necessary. The FAA is proposing this AD to address the unsafe condition
on these products.

DATES: The FAA must receive comments on this proposed AD by February
24, 2020.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Boeing
Commercial Airplanes, Attention: Contractual & Data Services (C&DS),
2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600;
telephone<PHONE_NUMBER>; internet https://www.myboeingfleet.com. You may
view this service information at the FAA, Transport Standards Branch,
2200 South 216th St., Des Moines, WA. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>. It is also
available on the internet at https://www.regulations.gov by searching
for and locating Docket No. FAA-2019-1071.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2019-
1071; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this NPRM, the regulatory evaluation, any comments received, and other
information. The street address for Docket Operations is listed above.
Comments will be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Julio C. Alvarez, Aerospace Engineer,
Systems and Equipment Section, FAA, Seattle ACO Branch, 2200 South
216th St., Des Moines, WA 98198; phone and fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2019-1071;
Product Identifier 2019-NM-165-AD'' at the beginning of your comments.
The FAA specifically invites comments on the overall regulatory,
economic, environmental, and energy aspects of this NPRM. The FAA will
consider all comments received by the closing date and may amend this
NPRM because of those comments.
    The FAA will post all comments we receive, without change, to
https://www.regulations.gov, including any personal information you
provide. The FAA will also post a report summarizing each substantive
verbal contact received about this NPRM.

Discussion

    The FAA has received reports indicating the presence of significant
corrosion of electrical connectors located in the MLG wheel well of
airplanes that land on runways treated with deicing fluids containing
potassium formate or potassium acetate. Corrosion and subsequent
moisture ingress may lead to electrical shorting of the connectors.
This condition, if not addressed, can cause incorrect function of
critical systems necessary for safe flight and landing.

Related Rulemaking

    AD 2005-18-23, Amendment 39-14264 (70 FR 54253, September 14, 2005)
(``AD 2005-18-23''), applies to Boeing Model 737-600, -700, -700C, -
800, and -900 series airplanes, and addresses the same unsafe condition
identified in this NPRM. Model 737-900ER series airplanes were not type
certificated at the time AD 2005-18-23 was issued. The FAA has
therefore determined that this NPRM is necessary to mandate the same
requirements on Model 737-900ER series airplanes.

Related Service Information Under 1 CFR Part 51

    This proposed AD would require Boeing Alert Service Bulletin 737-
24A1148, Revision 1, dated July 10, 2003, which the Director of the
Federal Register approved for incorporation by reference as of October
19, 2005 (70 FR 54253, September 14, 2005). This service information is
reasonably available because the interested parties have access to it
through their normal course of business or by the means identified in
the ADDRESSES section.

FAA's Determination

    The FAA is proposing this AD because the agency evaluated all the
relevant information and determined the unsafe condition described
previously is likely to exist or develop in other products of the same
type design.

Proposed AD Requirements

    This proposed AD would require repetitive records checks to
determine exposure to certain deicing fluids or repetitive inspections
for corrosion of electrical connectors, and applicable corrective
actions.
    The phrase ``corrective actions'' is used in this proposed AD.
Corrective actions correct or address any condition found. Corrective
actions in an AD could include, for example, repairs.

Differences Between This Proposed AD and the Service Information

    The effectivity of Boeing Alert Service Bulletin 737-24A1148,
Revision 1, dated July 10, 2003, does not specifically identify Model
737-900ER series airplanes; that airplane model was not type
certificated at the time the service information was issued. The
service information does, however, identify the line numbers for Model
737-900ER series airplanes, all of which are in Group 3, so the actions
of that service bulletin are appropriate and can be accomplished on
those airplanes.
    Boeing Alert Service Bulletin 737-24A1148, Revision 1, dated July
10, 2003, differs from this proposed AD in the cumulative areas of
backshell corrosion that need corrective action,

and in the compliance time for the respective corrective actions, which
are specified in paragraphs (g)(2)(i) through (ii) of this proposed AD.
These differences have been coordinated with Boeing. The proposed
requirements correspond to three alternative methods of compliance
approved for AD 2005-18-23 and reflect the relief provided for AD 2005-
18-23.
    Boeing Alert Service Bulletin 737-24A1148, Revision 1, dated July
10, 2003, specifies that airplanes exposed to affected runway deicing
fluids be inspected for corroded electrical connectors within 12
months. AD 2005-18-23 instead requires initially determining the
airplane's exposure to affected runway deicing fluids within 12 months,
and allows an additional 90 days to inspect for corrosion. For AD 2005-
18-23, the FAA had determined that the additional 90 days for the
inspection represented an acceptable interval of time for affected
airplanes to operate without jeopardizing safety. Therefore, since the
unsafe condition and airplane design are the same in AD 2005-18-23 and
this NPRM, the FAA has determined that 90 days is an appropriate
compliance time for the initial inspection in this proposed AD.
    Boeing Alert Service Bulletin 737-24A1148, Revision 1, dated July
10, 2003, and AD 2005-18-23 specify repeating the inspection at 12-
month intervals. However, the FAA determined that a longer interval
would provide an acceptable level of safety. The FAA therefore issued
alternative methods of compliance (AMOCs) for AD 2005-18-23 allowing
this inspection interval to be increased to 24 months. Therefore, this
proposed AD specifies a repetitive inspection interval of 24 months.

Costs of Compliance

    The FAA estimates that this proposed AD affects 346 airplanes of
U.S. registry. The FAA estimates the following costs to comply with
this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
             Action                     Labor cost          Parts cost     Cost per  product       operators
----------------------------------------------------------------------------------------------------------------
Repetitive records check.......  1 work-hour x $85 per                $0  $85 per inspection  Up to $29,410 per
                                  hour = $85 per                           cycle.              inspection cycle.
                                  inspection cycle.
Repetitive detailed inspection.  3 work-hours x $85 per                0  $255 per            Up to $88,230 per
                                  hour = $255 per                          inspection cycle.   inspection cycle.
                                  inspection cycle.
----------------------------------------------------------------------------------------------------------------

    The FAA estimates the following costs to do any necessary repairs
or replacements that would be required based on the results of the
proposed inspection. The FAA has no way of determining the number of
aircraft that might need these repairs or replacements:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
               Action                         Labor cost                Parts cost           Cost per product
----------------------------------------------------------------------------------------------------------------
Cleaning or replacement............  Up to 5 work-hours x $85     Up to $831............  Up to $1,256.
                                      per hour = Up to $425.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This proposed AD is issued in accordance with authority delegated
by the Executive Director, Aircraft Certification Service, as
authorized by FAA Order 8000.51C. In accordance with that order,
issuance of ADs is normally a function of the Compliance and
Airworthiness Division, but during this transition period, the
Executive Director has delegated the authority to issue ADs applicable
to transport category airplanes and associated appliances to the
Director of the System Oversight Division.

Regulatory Findings

    The FAA determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect 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.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

The Boeing Company: Docket No. FAA-2019-1071; Product Identifier
2019-NM-165-AD.

(a) Comments Due Date

    The FAA must receive comments by February 24, 2020.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all The Boeing Company Model 737-900ER series
airplanes, certificated in any category.

(d) Subject

    Air Transport Association (ATA) of America Code 24, Electrical
power.

(e) Unsafe Condition

    This AD was prompted by reports of significant corrosion of
electrical connectors located in the main landing gear (MLG) wheel
well. The FAA is issuing this AD to address corrosion and subsequent
moisture ingress that may lead to electrical shorting of the
connectors and incorrect functioning of critical systems necessary
for safe flight and landing.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Required Actions

    Within 12 months after the effective date of this AD: Do the
actions required by paragraph (g)(1) or (2) of this AD.
    (1) Determine airplane exposure to runway deicing fluids
containing potassium formate or potassium acetate by reviewing
airport data on the types of components in the deicing fluid used at
airports that support airplane operations.
    (i) If the airplane has not been exposed: Repeat the
requirements specified in paragraph (g)(1) of this AD thereafter at
intervals not to exceed 24 months.
    (ii) If the airplane has been exposed: Within 90 days after that
determination is made, do the inspection required by paragraph
(g)(2) of this AD. Repeat the inspection thereafter at intervals not
to exceed 24 months.
    (2) Do a detailed inspection of the electrical connectors,
including the contacts and backshells of the line replaceable unit
(LRU) in the wheel well of the MLG, for corrosion in accordance with
the Accomplishment Instructions of Boeing Alert Service Bulletin
737-24A1148, Revision 1, dated July 10, 2003. Perform applicable
corrective actions at the applicable times, as specified in
paragraphs (g)(2)(i) through (iii) of this AD, in accordance with
the Accomplishment Instructions of Boeing Alert Service Bulletin
737-24A1148, Revision 1, dated July 10, 2003. Repeat the inspection
thereafter at intervals not to exceed 24 months. For the purposes of
this AD, a detailed inspection is defined as an intensive visual
examination of a specific structural area, system, installation, or
assembly to detect damage, failure, or irregularity. Available
lighting is normally supplemented with a direct source of good
lighting at intensity deemed appropriate by the inspector.
Inspection aids such as mirror, magnifying lenses, etc., may be
used. Surface cleaning and elaborate access procedures may be
required.
    (i) If the total backshell surface area corrosion is 10 percent
or less, clean the backshell(s) before further flight.
    (ii) If the total backshell surface area corrosion is greater
than 10 percent but less than 20 percent, replace the connectors and
backshells within 30 days after the detailed inspection.
    (iii) If the total backshell surface area corrosion is 20
percent or more, replace the connectors and backshells before
further flight.

(h) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle ACO Branch, FAA, has the authority to
approve AMOCs for this AD, if requested using the procedures found
in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request
to your principal inspector or local Flight Standards District
Office, as appropriate. If sending information directly to the
manager of the certification office, send it to the attention of the
person identified in paragraph (i)(1) of this AD. Information may be
emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair, modification, or alteration required by this AD
if it is approved by The Boeing Company Organization Designation
Authorization (ODA) that has been authorized by the Manager, Seattle
ACO Branch, FAA, to make those findings. To be approved, the repair
method, modification deviation, or alteration deviation must meet
the certification basis of the airplane, and the approval must
specifically refer to this AD.
    (4) AMOCs approved previously for AD 2005-18-23, Amendment 39-
14264 (70 FR 54253, September 14, 2005) (``AD 2005-18-23''), are
approved as AMOCs for the corresponding provisions of this AD.

(i) Related Information

    (1) For more information about this AD, contact Julio C.
Alvarez, Aerospace Engineer, Systems and Equipment Section, FAA,
Seattle ACO Branch, 2200 South 216th St., Des Moines, WA 98198;
phone and fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Contractual & Data Services
(C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-
5600; telephone<PHONE_NUMBER>; internet https://www.myboeingfleet.com. You may view this service information at the
FAA, Transport Standards Branch, 2200 South 216th St., Des Moines,
WA. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

    Issued on December 26, 2019.
Jeffrey E. Duven,
Director, System Oversight Division, Aircraft Certification Service.
[FR Doc. 2019-28469 Filed 1-9-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 82 (Tuesday, April 28, 2020)]
[Proposed Rules]
[Pages 23495-23496]
[FR Doc No: 2020-08956]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2020-0298; Airspace Docket No. 19-ANM-97]
RIN 2120-AA66

Proposed Establishment of Class E Airspace; Quinter, KS

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This action proposes to establish Class E airspace extending
upward from 700 feet above the surface at Gove County Airport, Quinter,
KS, to accommodate new area navigation (RNAV) procedures at the
airport. This action would ensure the safety and management of
instrument flight rules (IFR) operations within the National Airspace
System.

DATES: Comments must be received on or before June 12, 2020.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE, West
Building Ground Floor, Room W12-140, Washington, DC 20590; telephone:
(800) 647-5527, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2020-0298; Airspace Docket No. 19-ANM-97, at the beginning of your
comments. You may also submit comments through the internet at https://www.regulations.gov.
    FAA Order 7400.11D, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at https://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11D at NARA, email<EMAIL_ADDRESS>or go to https://www.archives.gov/federal_register/cfr/ibr_locations.html.

FOR FURTHER INFORMATION CONTACT: Richard Roberts, Federal Aviation
Administration, Operations Support Group, Western Service Center, 2200
S 216th Street, Des Moines, WA, 98198-6547; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would establish Class E airspace at Gove County Airport, Quinter,
KS in support of IFR operations at the airport.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (Docket No. FAA-
2020-0298; Airspace Docket No. 19-ANM-97) and be submitted in
triplicate to DOT Docket Operations (see ADDRESSES section for address
and phone number). You may also submit comments through the internet at
https://www.regulations.gov.
    Persons wishing the FAA to acknowledge receipt of their comments on
this notice must submit with those comments a self-addressed, stamped
postcard on which the following statement is made: ``Comments to Docket
No. FAA-2020-0298; Airspace Docket No. 19-ANM-97.'' The postcard will
be date/time stamped and returned to the commenter.
    All communications received on or before the specified closing date
for comments will be considered before taking action on the proposed
rule. The proposal contained in this notice may be changed in light of
the comments received. A report summarizing each substantive public
contact with FAA personnel concerned with this rulemaking will be filed
in the docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
internet at https://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at https://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for the address and phone number)
between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined between 8:00 a.m. and
4:30 p.m., Monday through Friday, except federal holidays, at the
Northwest Mountain Regional Office of the Federal Aviation
Administration, Air Traffic Organization, Western Service Center,
Operations Support Group, 2200 S 216th St., Des Moines, WA 98198-6547.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11D, Airspace
Designations and Reporting Points, dated August 8, 2019, and effective
September 15, 2019. FAA Order 7400.11D is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11D lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) part 71 by establishing Class E airspace extending
upward from 700 feet above ground level at Gove County Airport,
Quinter, KS. The Class E airspace extending upward from 700 feet AGL
would be established to within 5.5 miles of the Gove County Airport.

This area would provide airspace for new Area Navigation Procedures at
Gove County Airport, Quinter, KS.
    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.11D, dated August 8, 2019 and effective September 15,
2019, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designation listed in this document will be published
subsequently in the Order. FAA Order 7400.11, Airspace Designations and
Reporting Points, is published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial, and unlikely to result in adverse or negative
comments. It, therefore: (1) Is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Given this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this proposed rule, when promulgated, would not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal
Aviation Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority:  49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11D,
Airspace Designations and Reporting Points, dated August 8, 2019, and
effective September 15, 2019, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ANM WA E5 Quinter, KS

Gove County Airport, KS
    (Lat. 39[deg]02'19'' N, long. 100[deg]14'02'' W)

    That airspace extending upward from 700 feet above the surface
within a 5.5-mile radius of the Gove County airport, Quinter, KS.

    Issued in Seattle, Washington, on April 21, 2020.
Shawn M. Kozica,
Manager, Operations Support Group, Western Service Center.
[FR Doc. 2020-08956 Filed 4-27-20; 8:45 am]
BILLING CODE 4910-13-P