[Federal Register Volume 81, Number 55 (Tuesday, March 22, 2016)]
[Proposed Rules]
[Page 15173]
[FR Doc No: 2016-06397]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 73 and 74

[Docket No. FDA-2016-F-0821]

Milton W. Chu, M.D.; Filing of Color Additive Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of petition.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing
that we have filed a petition, submitted by Milton W. Chu, M.D.,
proposing that the color additive regulations be amended to provide for
the safe use of titanium dioxide and [phthalocyaninato (2-)] copper as
orientation marks for intraocular lenses.

DATES: The color additive petition was filed on February 19, 2016.

FOR FURTHER INFORMATION CONTACT: Laura Dye, Center for Food Safety and
Applied Nutrition (HFS-265), Food and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740-3835,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under section 721(d)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379e(d)(1)), we are giving notice
that we have filed a color additive petition (CAP 6C0305), submitted by
Milton W. Chu, M.D., 5800 Santa Rosa Rd., Suite 111, Camarillo, CA
93012. The petition proposes to amend the color additive regulations in
Sec.  73.3126 Titanium dioxide (21 CFR 73.3126) and Sec.  74.3045
[Phthalocyaninato (2-)] copper (21 CFR 74.3045) to provide for the safe
use of titanium dioxide and [phthalocyaninato (2-)] copper as
orientation marks for intraocular lenses.
    We have determined under 21 CFR 25.32(l) 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.

    Dated: March 17, 2016.
Dennis M. Keefe,
Director, Office of Food Additive Safety, Center for Food Safety and
Applied Nutrition.
[FR Doc. 2016-06397 Filed 3-21-16; 8:45 am]
BILLING CODE 4164-01-P


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

1. Agency/ Subagency originating request U. S. EPA/ Office of Water/ Office of Wetlands, Oceans and Watersheds 2. OMB control number b. X None a__ __ __ __  __ __ __ __ 2040 3. Type of information collection ( check one) a. X New collection b. G Revision of a currently approved collection c. G Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. X Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes X No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. G Three years from approval date b. X Other Specify: One Year 7. Title Surveys to Determine the Effectiveness of No Discharge Zones ( NDZs) for Vessel Sewage and Marine Sanitation Devices 8. Agency form number( s) ( If applicable) EPA ICR No. 2107.01 9. Keywords marine sanitation devices, MSDs, no discharge zones, NDZs, vessel sewage,

10. Abstract This information collection request ( ICR) is for a series of surveys to be conducted to determine the effectiveness of no discharge zones ( NDZs) for vessel sewage and marine sanitation devices ( MSDs) in removing harmful pollutants from the waste stream of the device. This ICR requests approval to collect information from boat owners and operators, marina owners and operators, and State and local government officials regarding the effectiveness of NDZs. It also requests approval to collect information regarding the effectiveness of MSDs in removing harmful pollutants from the waste stream of the device. This information will be gathered from MSD manufacturers and U. S. Coast Guard Accepted Independent Laboratories. This information will be used to address future vessel sewage discharge program direction issues and to assist EPA in promulgating regulations to implement Title XIV: Certain Alaskan Cruise Ship Operations.

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

a. X Individuals or households d. Farms b. P Business or other for profit e. X Federal Government c. Not for profit institutions f. X State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X")

a. X Voluntary b. G Required to obtain or retain benefits c. G Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 1366 b. Total annual responses 1366 1. Percentage of these responses collected electronically 0 % c. Total hours requested 474 d. Current OMB inventory 0 e. Difference 474 f. Explanation of difference 1. Program Change 474 2. Adjustment 0 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars)

a. Total annualized capital/ startup costs 0 b. Total annual costs ( O& M) 0 c. Total annualized cost requested 0 d. Current OMB inventory 0 e. Difference 0 f. Explanation of difference 1. Program change 0 2. Adjustment 0 15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. __ Application for benefits e. X__ Program planning or management b. _ P Program evaluation f. __ Research c. __ General purpose statistics g. _ X Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. Q Recordkeeping b. Q Third party disclosure c. X Reporting 1. Q On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. Q Semi annually 6. Q Annually 7. Q Biannually 8. X Other ( describe) one time collection 17. Statistical methods Does this information collection employ statistical methods? X Yes Q No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: James C. Woodley Phone: ( 202) 566 1287 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

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

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

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

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

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

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

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

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( I) Why the information is being collected' ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( I) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

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

Signature of Program Official Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Environmental Information Date OMB 83 I 10/ 95 Certification Requirement for Paperwork Reduction Act Submissions 5 CFR 1320.9 reads " As part of the agency submission to OMB of a proposed collection of information, the agency ( through the head of the agency, the Senior Official or their designee) shall certify ( and provide a record supporting such certification) that the proposed collection of information

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

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

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

"( 1) establishing differing compliance or reporting requirements or timetables that take into account the resources available to those who are to respond; "( 2) the clarification, consolidation, or simplification of compliance and reporting requirements; or collection of information , or any part thereof; "( 3) an exemption from coverage of the collection of information, or any part thereof;

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

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

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

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

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

"( I) uses effective and efficient statistical survey methodology appropriate to the purpose for which the information is to be collected; and "( j) to the maximum extent practicable, uses appropriate information technology to reduce burden and improve data quality, agency efficiency and responsiveness to the public."

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

"( 3) informs and provides reasonable notice to the potential persons to whom the collection of information is addressed of: "( I) the reasons the information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( ii) the way such information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( iii) an estimate, to the extent practicable, of the average burden of the collection ( together with a request that the public direct to the agency any comments concerning the accuracy of this burden estimate and any suggestions for reducing this burden); "( iv) whether responses to the collection of information are voluntary, required to obtain or retain a benefit ( citing authority), or mandatory ( citing authority); "( v) the nature and extent of confidentiality to be provided, if any ( citing authority); and "( vi) the fact that any agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number."

OMB 83 I ( Instructions) 10/ 95


 1 MEMORANDUM Subject: Information from the North Carolina Petroleum Marketers Association ( NCPMA) Regarding Heating Oil Use in North Carolina From: Jeff Herzog, Mechanical Engineer Office of Transportation and Air Quality To: Environmental Protection Agency ( EPA), Air Docket A 2001 28 Date: April 21, 2004 On April 5, 2004, I called Tim Laughlin of NCPMA to request information regarding patterns of heating oil use in the State of North Carolina. Mr. Laughlin sent me the following EMail and attachments in response to my request:

Tim Laughlin < tlaughlin@ ncpma. org> 04/ 05/ 2004 01: 09 PM To: Jeff Herzog/ AA/ USEPA/ US@ EPA cc: Subject: NC Fuel Oil Use Jeff,

The two largest heating oil Marketers in Asheville get their fuel form Spartanburg, SC. They said the terminal is about 60 miles from them.

Let me know if you need more info.

Tim Laughlin, PE Technical Director NC Petroleum Marketers Association 7300 Glenwood Ave. Raleigh, NC 27612 Phone: 919 782 4411 Fax: 919 782 4414 Attachments to E Mail: 2 Attachment # 1:

2000 Census Home Heating in North Carolina by County Prepared by the NC Petroleum Marketers Association, 11 11 02 County Total Homes Utility Natural Gas Propane Electricity Strip & Heat Pump Heating Oil & Kerosene Oil Percent Of County Total Alamance 51,584 24,211 6,511 16,783 2,996 5.8 Alexander 13,137 136 1,512 7,642 3,130 23.8 Alleghany 4,593 8 623 1,115 2,383 51.9 Anson 9,204 895 3,060 3,090 1,780 19.3 Ashe 10,411 24 808 1,999 6,478 62.2 Avery 6,532 16 964 1,233 3,774 57.8 Beaufort 18,319 2,571 7,282 6,408 1,538 8.4 Bertie 7,743 124 2,873 2,645 1,494 19.3 Bladen 12,897 722 4,643 5,975 1,105 8.6 Brunswick 30,438 300 6,183 21,484 1,910 6.3 Buncombe 85,776 16,638 6,041 32,493 27,106 31.6 Burke 34,528 4,075 2,523 16,555 9,876 28.6 Cabarrus 49,519 19,468 3,085 21,652 4,435 9.0 Caldwell 30,768 3,733 2,629 14,252 8,458 27.5 Camden 2,662 26 685 1,372 533 20.0 Carteret 25,204 179 4,443 18,350 1,679 6.7 Caswell 8,670 336 2,539 3,680 1,433 16.5 Catawba 55,533 11,835 2,942 32,477 6,843 12.3 Chatham 19,741 3,066 5,828 8,044 1,746 8.8 Cherokee 10,336 84 3,016 3,930 2,302 22.3 Chowan 5,580 210 2,261 1,991 965 17.3 Clay 3,847 22 1,656 1,281 633 16.5 Cleveland 37,046 9,633 1,904 18,677 5,554 15.0 Columbus 21,308 385 8,231 9,770 2,441 11.5 Craven 34,582 2,966 6,510 22,388 2,020 5.8 Cumberland 107,358 23,864 11,056 64,766 6,515 6.1 Currituck 6,902 31 1,662 4,104 842 12.2 Dare 12,690 106 1,595 10,072 647 5.1 Davidson 58,156 8,473 4,134 31,816 11,849 20.3 Davie 13,750 1,096 950 8,011 3,012 21.9 Duplin 18,267 335 7,991 8,693 881 4.8 Durham 89,015 35,446 4,569 44,022 4,231 4.7 Edgecomb 20,392 6,276 4,827 7,652 1,146 5.6 Forsyth 123,851 32,646 3,763 63,585 22,223 17.9 Franklin 17,843 497 6,071 8,933 1,621 9.0 Gaston 73,936 35,677 3,628 27,862 5,605 7.6 Gates 3,901 57 1,250 1,588 728 18.7 Graham 3,354 22 800 692 1,571 46.8 Granville 16,654 2,756 4,249 7,397 1,153 6.9 Greene 6,696 376 2,315 3,144 589 8.8 Guilford 168,667 76,608 7,941 71,024 10,715 6.4 Halifax 22,122 4,624 4,933 8,312 3,224 14.6 Harnett 33,800 4,283 7,631 19,724 1,506 4.5 3 Haywood 23,100 168 3,438 6,912 10,997 47.6 Henderson 37,414 9,688 3,317 16,461 6,375 17.0 Hertford 8,953 709 2,157 4,084 1,733 19.4 Hoke 11,373 657 2,598 7,131 726 6.4 Hyde 2,185 73 1,203 577 172 7.9 Iredell 47,360 13,301 3,317 23,027 6,073 12.8 Jackson 13,191 150 3,118 5,846 2,882 21.8 Johnston 46,595 3,641 14,032 25,989 2,182 4.7 Jones 4,061 37 1,338 2,099 482 11.7 Lee 18,466 3,730 2,820 10,502 991 5.4 Lenoir 23,862 5,088 5,274 11,673 1,518 6.4 County Homes Gas Propane Electricity Fuel Oil Percent Oil Lincoln 24,041 2,893 2,102 14,795 3,346 13.9 McDowell 16,604 152 1,565 6,613 7,120 42.9 Macon 12,828 133 3,920 5,268 2,371 18.5 Madison 8,000 43 758 1,477 4,876 61.0 Martin 10,020 332 4,107 3,763 1,387 13.8 Mecklenburg 273,416 142,812 4,009 118,653 6,568 2.4 Mitchell 6,551 30 585 1,016 4,380 66.9 Montgomery 9,848 242 2,469 4,231 2,275 23.1 Moore 30,713 2,028 4,856 19,937 3,002 9.8 Nash 33,644 8,481 8,461 14,107 1,650 4.9 New Hanover 68,183 8,147 2,861 53,915 2,641 3.9 Northhampton 8,691 168 2,737 3,551 1,822 21.0 Onslow 48,122 362 4,521 40,434 2,080 4.3 Orange 45,863 15,295 5,860 21,758 1,521 3.3 Pamlico 5,178 74 1,530 2,931 500 9.7 Pasquotank 12,907 169 2,836 6,992 2,592 20.1 Pender 16,054 123 2,987 11,785 743 4.6 Perquimans 4,645 111 1,547 1,921 802 17.3 Person 14,085 2,716 3,648 5,394 1,577 11.2 Pitt 52,539 11,320 7,993 30,475 2,107 4.0 Polk 7,908 778 1,269 3,764 1,641 20.8 Randolph 50,659 8,358 8,109 24,797 7,304 14.4 Richmond 17,873 3,688 3,909 7,840 1,978 11.1 Roberson 43,677 6,470 11,413 22,052 2,502 5.7 Rockingham 36,989 10,687 3,684 15,884 5,151 13.9 Rowan 49,940 14,687 2,633 24,173 7,175 14.4 Rutherford 25,191 2,974 3,286 12,167 5,626 22.3 Sampson 22,273 1,597 7,457 10,751 2,020 9.1 Scotland 13,399 2,298 2,445 7,322 1,040 7.8 Stanly 22,223 2,411 4,487 8,452 6,172 27.8 Stokes 17,579 296 2,177 9,842 3,976 22.6 Surry 28,408 163 3,501 13,160 10,205 35.9 Swain 5,137 59 1,234 1,754 1,421 27.7 Transyvania 12,320 2,209 2,342 4,964 2,125 17.2 Tyrell 1,537 25 652 522 237 15.4 Union 43,390 12,680 7,120 19,679 3,002 6.9 Vance 16,199 3,443 2,136 7,779 2,255 13.9 4 Wake 242,040 100,902 17,686 117,273 4,265 1.8 Warren 7,708 93 2,108 3,404 1,576 20.4 Washington 5,367 109 2,246 1,992 773 14.4 Watagua 16,540 176 2,527 5,784 6,990 42.3 Wayne 42,612 5,114 10,422 23,936 2,706 6.3 Wilkes 26,650 159 4,493 12,082 8,419 31.6 Wilson 28,613 10,610 4,578 11,263 1,706 6.0 Yadkin 14,505 58 1,658 7,606 4,412 30.4 Yancey 7,472 24 595 643 5,441 72.8 Totals 3,132,013 757,777 394,275 1,528,885 368,279 11.76 This does not include wood, solar, coal and other sources of home heating. 1980 NC Oil/ Kerosene Heated Homes: 819,883 of 2,043,291 or 41%. 1990 NC Oil/ Kerosene heated Homes: 567,025 of 2,517,026 or 23%. 2000 Census for home heating has 24.2% Natural Gas, 12.6% Propane, 48.8% Electric/ Heat Pump. For NC city/ town home heating census data go to web site at http:// factfinder. census. gov/ servlet/ BasicFactsServlet?_ basicfacts= 1&_ mult1= 22553504&_ geo2= 160&_ geoType1= 91910128&_ current= 1&_ action=_ geoTypeSelected&_ child_ geo_ id=&_ lang= en Enter city/ town under " select a place". ( TL) Percentage wise the county with the most oilheat homes is Yancey at 72.8%, the county with the least oil heated homes is Wake at 1.8% 5 Attachment # 2:

NC Average Home Use: June 28, 2002 2000 368,279 homes Fuel Oil No. 2 129,960,000 K 1 83,110,000 Average Home Use 578.55 gallons 1998 408,025 homes Fuel Oil No. 2 131,451,000 K 1 125,513,000 Average Home Use 629.78 gallons 1996 447,771 homes Fuel Oil No. 2 181,453,000 K 1 106,932,000 Average Home Use 644.04 gallons Average of 2000, 1998, 1996 617.5 gallons This would include K 1 consumption of homes that do not use K 1 as the primary source of heat ( heat pumps/ basements/ garages). Using national estimates, backing out K 1 homes of the NC Census at 10% of the market, we can arrive at a an educated guess of the average No 2 fuel oil per No. 2 heated home.

Average No 2 Fuel Use per No. 2 Home 400 gallons per year


Source: http:// uscode. house. gov 1/ 22/ 2002 CONGRESSIONAL REVIEW ACT TITLE 5  GOVERNMENT ORGANIZATION AND EMPLOYEES PART I  THE AGENCIES GENERALLY CHAPTER 8  CONGRESSIONAL REVIEW OF AGENCY RULEMAKING Sec. 801. Congressional review. 802. Congressional disapproval procedure. 803. Special rule on statutory, regulatory, and judicial deadlines. 804. Definitions. 805. Judicial review. 806. Applicability; severability. 807. Exemption for monetary policy. 808. Effective date of certain rules.

***  HEADSec 801. Congressional review  STATUTE ( a)( 1)( A) Before a rule can take effect, the Federal agency promulgating such rule shall submit to each House of the Congress and to the Comptroller General a report containing  ( i) a copy of the rule; ( ii) a concise general statement relating to the rule, including whether it is a major rule; and ( iii) the proposed effective date of the rule. ( B) On the date of the submission of the report under subparagraph ( A), the Federal agency promulgating the rule shall submit to the Comptroller General and make available to each House of Congress  ( i) a complete copy of the cost benefit analysis of the rule, if any; ( ii) the agency's actions relevant to sections 603, 604, 605, 607, and 609; ( iii) the agency's actions relevant to sections 202, 203, 204, and 205 of the Unfunded Mandates Reform Act of 1995; and ( iv) any other relevant information or requirements under any other Act and any relevant Executive orders. ( C) Upon receipt of a report submitted under subparagraph ( A), each House shall provide copies of the report to the chairman and ranking member of each standing committee with jurisdiction under the rules of the House of Representatives or the Senate to report a bill to amend the provision of law under which the rule is issued. ( 2)( A) The Comptroller General shall provide a report on each major rule to the committees of jurisdiction in each House of the Congress by the end of 15 calendar days after the submission or publication date as provided in section 802( b)( 2). The report of the Comptroller General shall include an assessment of the agency's compliance with procedural steps required by paragraph ( 1)( B). ( B) Federal agencies shall cooperate with the Comptroller General by providing information relevant to the Comptroller General's report under subparagraph ( A). ( 3) A major rule relating to a report submitted under paragraph ( 1) shall take effect on the latest of  ( A) the later of the date occurring 60 days after the date on which  ( i) the Congress receives the report submitted under paragraph ( 1); or ( ii) the rule is published in the Federal Register, if so published; ( B) if the Congress passes a joint resolution of disapproval described in section 802 relating to the rule, and the President signs a veto of such resolution, the earlier date  ( i) on which either House of Congress votes and fails to override the veto of the President; or ( ii) occurring 30 session days after the date on which the Congress received the veto and objections of the President; or ( C) the date the rule would have otherwise taken effect, if not for this section ( unless a joint resolution of disapproval under section 802 is enacted). ( 4) Except for a major rule, a rule shall take effect as otherwise provided by law after submission to Congress under paragraph ( 1). ( 5) Notwithstanding paragraph ( 3), the effective date of a rule shall not be delayed by operation of this chapter beyond the date on which either House of Congress votes to reject a joint resolution of disapproval under section 802. ( b)( 1) A rule shall not take effect ( or continue), if the Congress enacts a joint resolution of disapproval, described under section 802, of the rule. ( 2) A rule that does not take effect ( or does not continue) under paragraph ( 1) may not be reissued in substantially the same form, and a new rule that is substantially the same as such a rule may not be issued, unless the reissued or new rule is specifically authorized by a law enacted after the date of the joint resolution disapproving the original rule. ( c)( 1) Notwithstanding any other provision of this section ( except subject to paragraph ( 3)), a rule that would not take effect by reason of subsection ( a)( 3) may take effect, if the President makes a determination under paragraph ( 2) and submits written notice of such determination to the Congress. ( 2) Paragraph ( 1) applies to a determination made by the President by Executive order that the rule should take effect because such rule is  ( A) necessary because of an imminent threat to health or safety or other emergency; ( B) necessary for the enforcement of criminal laws; ( C) necessary for national security; or ( D) issued pursuant to any statute implementing an international trade agreement. ( 3) An exercise by the President of the authority under this subsection shall have no effect on the procedures under section 802 or the effect of a joint resolution of disapproval under this section. ( d)( 1) In addition to the opportunity for review otherwise provided under this chapter, in the case of any rule for which a report was submitted in accordance with subsection ( a)( 1)( A) during the period beginning on the date occurring  ( A) in the case of the Senate, 60 session days, or ( B) in the case of the House of Representatives, 60 legislative days, before the date the Congress adjourns a session of Congress through the date on which the same or succeeding Congress first convenes its next session, section 802 shall apply to such rule in the succeeding session of Congress. ( 2)( A) In applying section 802 for purposes of such additional review, a rule described under paragraph ( 1) shall be treated as though  ( i) such rule were published in the Federal Register ( as a rule that shall take effect) on  ( I) in the case of the Senate, the 15th session day, or ( II) in the case of the House of Representatives, the 15th legislative day, after the succeeding session of Congress first convenes; and ( ii) a report on such rule were submitted to Congress under subsection ( a)( 1) on such date. ( B) Nothing in this paragraph shall be construed to affect the requirement under subsection ( a)( 1) that a report shall be submitted to Congress before a rule can take effect. ( 3) A rule described under paragraph ( 1) shall take effect as otherwise provided by law ( including other subsections of this section). ( e)( 1) For purposes of this subsection, section 802 shall also apply to any major rule promulgated between March 1, 1996, and the date of the enactment of this chapter. ( 2) In applying section 802 for purposes of Congressional review, a rule described under paragraph ( 1) shall be treated as though  ( A) such rule were published in the Federal Register on the date of enactment of this chapter; and ( B) a report on such rule were submitted to Congress under subsection ( a)( 1) on such date. ( 3) The effectiveness of a rule described under paragraph ( 1) shall be as otherwise provided by law, unless the rule is made of no force or effect under section 802. ( f) Any rule that takes effect and later is made of no force or effect by enactment of a joint resolution under section 802 shall be treated as though such rule had never taken effect. ( g) If the Congress does not enact a joint resolution of disapproval under section 802 respecting a rule, no court or agency may infer any intent of the Congress from any action or inaction of the Congress with regard to such rule, related statute, or joint resolution of disapproval.

 HEADSec 802. Congressional disapproval procedure  STATUTE ( a) For purposes of this section, the term '' joint resolution'' means only a joint resolution introduced in the period beginning on the date on which the report referred to in section 801( a)( 1)( A) is received by Congress and ending 60 days thereafter ( excluding days either House of Congress is adjourned for more than 3 days during a session of Congress), the matter after the resolving clause of which is as follows: '' That Congress disapproves the rule submitted by the _ _ relating to _ _, and such rule shall have no force or effect.'' ( The blank spaces being appropriately filled in). ( b)( 1) A joint resolution described in subsection ( a) shall be referred to the committees in each House of Congress with jurisdiction. ( 2) For purposes of this section, the term '' submission or publication date'' means the later of the date on which  ( A) the Congress receives the report submitted under section 801( a)( 1); or ( B) the rule is published in the Federal Register, if so published. ( c) In the Senate, if the committee to which is referred a joint resolution described in subsection ( a) has not reported such joint resolution ( or an identical joint resolution) at the end of 20 calendar days after the submission or publication date defined under subsection ( b)( 2), such committee may be discharged from further consideration of such joint resolution upon a petition supported in writing by 30 Members of the Senate, and such joint resolution shall be placed on the calendar. ( d)( 1) In the Senate, when the committee to which a joint resolution is referred has reported, or when a committee is discharged ( under subsection ( c)) from further consideration of a joint resolution described in subsection ( a), it is at any time thereafter in order ( even though a previous motion to the same effect has been disagreed to) for a motion to proceed to the consideration of the joint resolution, and all points of order against the joint resolution ( and against consideration of the joint resolution) are waived. The motion is not subject to amendment, or to a motion to postpone, or to a motion to proceed to the consideration of other business. A motion to reconsider the vote by which the motion is agreed to or disagreed to shall not be in order. If a motion to proceed to the consideration of the joint resolution is agreed to, the joint resolution shall remain the unfinished business of the Senate until disposed of. ( 2) In the Senate, debate on the joint resolution, and on all debatable motions and appeals in connection therewith, shall be limited to not more than 10 hours, which shall be divided equally between those favoring and those opposing the joint resolution. A motion further to limit debate is in order and not debatable. An amendment to, or a motion to postpone, or a motion to proceed to the consideration of other business, or a motion to recommit the joint resolution is not in order. ( 3) In the Senate, immediately following the conclusion of the debate on a joint resolution described in subsection ( a), and a single quorum call at the conclusion of the debate if requested in accordance with the rules of the Senate, the vote on final passage of the joint resolution shall occur. ( 4) Appeals from the decisions of the Chair relating to the application of the rules of the Senate to the procedure relating to a joint resolution described in subsection ( a) shall be decided without debate. ( e) In the Senate the procedure specified in subsection ( c) or ( d) shall not apply to the consideration of a joint resolution respecting a rule  ( 1) after the expiration of the 60 session days beginning with the applicable submission or publication date, or ( 2) if the report under section 801( a)( 1)( A) was submitted during the period referred to in section 801( d)( 1), after the expiration of the 60 session days beginning on the 15th session day after the succeeding session of Congress first convenes. ( f) If, before the passage by one House of a joint resolution of that House described in subsection ( a), that House receives from the other House a joint resolution described in subsection ( a), then the following procedures shall apply: ( 1) The joint resolution of the other House shall not be referred to a committee. ( 2) With respect to a joint resolution described in subsection ( a) of the House receiving the joint resolution  ( A) the procedure in that House shall be the same as if no joint resolution had been received from the other House; but ( B) the vote on final passage shall be on the joint resolution of the other House. ( g) This section is enacted by Congress  ( 1) as an exercise of the rulemaking power of the Senate and House of Representatives, respectively, and as such it is deemed a part of the rules of each House, respectively, but applicable only with respect to the procedure to be followed in that House in the case of a joint resolution described in subsection ( a), and it supersedes other rules only to the extent that it is inconsistent with such rules; and ( 2) with full recognition of the constitutional right of either House to change the rules ( so far as relating to the procedure of that House) at any time, in the same manner, and to the same extent as in the case of any other rule of that House.

 HEADSec 803. Special rule on statutory, regulatory, and judicial deadlines  STATUTE ( a) In the case of any deadline for, relating to, or involving any rule which does not take effect ( or the effectiveness of which is terminated) because of enactment of a joint resolution under section 802, that deadline is extended until the date 1 year after the date of enactment of the joint resolution. Nothing in this subsection shall be construed to affect a deadline merely by reason of the postponement of a rule's effective date under section 801( a). ( b) The term '' deadline'' means any date certain for fulfilling any obligation or exercising any authority established by or under any Federal statute or regulation, or by or under any court order implementing any Federal statute or regulation.

 HEADSec 804. Definitions  STATUTEFor purposes of this chapter  ( 1) The term '' Federal agency'' means any agency as that term is defined in section 551( 1). ( 2) The term '' major rule'' means any rule that the Administrator of the Office of Information and Regulatory Affairs of the Office of Management and Budget finds has resulted in or is likely to result in  ( A) an annual effect on the economy of $ 100,000,000 or more; ( B) a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; or ( C) significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States based enterprises to compete with foreign based enterprises in domestic and export markets. The term does not include any rule promulgated under the Telecommunications Act of 1996 and the amendments made by that Act. ( 3) The term '' rule'' has the meaning given such term in section 551, except that such term does not include  ( A) any rule of particular applicability, including a rule that approves or prescribes for the future rates, wages, prices, services, or allowances therefor, corporate or financial structures, reorganizations, mergers, or acquisitions thereof, or accounting practices or disclosures bearing on any of the foregoing; ( B) any rule relating to agency management or personnel; or ( C) any rule of agency organization, procedure, or practice that does not substantially affect the rights or obligations of non agency parties.

 HEADSec 805. Judicial review  STATUTENo determination, finding, action, or omission under this chapter shall be subject to judicial review.

 HEADSec 806. Applicability; severability  STATUTE ( a) This chapter shall apply notwithstanding any other provision of law. ( b) If any provision of this chapter or the application of any provision of this chapter to any person or circumstance, is held invalid, the application of such provision to other persons or circumstances, and the remainder of this chapter, shall not be affected thereby.

 HEADSec 807. Exemption for monetary policy  STATUTENothing in this chapter shall apply to rules that concern monetary policy proposed or implemented by the Board of Governors of the Federal Reserve System or the Federal Open Market Committee.

 HEADSec 808. Effective date of certain rules  STATUTENotwithstanding section 801  ( 1) any rule that establishes, modifies, opens, closes, or conducts a regulatory program for a commercial, recreational, or subsistence activity related to hunting, fishing, or camping, or ( 2) any rule which an agency for good cause finds ( and incorporates the finding and a brief statement of reasons therefor in the rule issued) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest, shall take effect at such time as the Federal agency promulgating the rule determines ###


[Federal Register: January 27, 2006 (Volume 71, Number 18)]
[Notices]
[Page 4574]
[DOCID:fr27ja06-41]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-174-000]

Dominion Transmission, Inc.; Notice of Proposed Changes in FERC
Gas Tariff

January 20, 2006.
    Take notice that on January 13, 2006, Dominion Transmission, Inc.
(DTI) tendered for filing as part of its FERC Gas Tariff, Third Revised
Volume No. 1, the following tariff sheets, to become effective February
13, 2006:

Second Revised Sheet No. 103;
Third Revised Sheet No. 212A;
Second Revised Sheet No. 653;
Second Revised Sheet No. 1008;
Second Revised Sheet No. 1009;
Second Revised Sheet No. 1010;
Second Revised Sheet No. 1043;
Third Revised Sheet No. 1088.

    DTI states that the purpose of this filing is to change the penalty
provisions for violations of curtailment or interruption orders or
operational flow orders in DTI's FERC Gas Tariff from the existing
fixed price penalties to the higher of its fixed price penalties or
multiples of daily indexed prices.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
Sec.  154.210 of the Commission's regulations (18 CFR 154.210). Anyone
filing an intervention or protest must serve a copy of that document on
the Applicant. Anyone filing an intervention or protest on or before
the intervention or protest date need not serve motions to intervene or
protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible online at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-1000 Filed 1-26-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 217 (Monday, November 13, 2017)]
[Rules and Regulations]
[Pages 52212-52213]
[FR Doc No: 2017-24508]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2017-1011]
RIN 1625-AA00

Safety Zone, Delaware River; Pipeline Removal

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule; correcting amendment.

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

SUMMARY: The Coast Guard is correcting a temporary final rule that
appeared in the Federal Register on November 6, 2017. The document
issued a temporary safety zone for in the Mifflin Range on the Delaware
River to facilitate pipeline removal in preparation for the deepening
of the Delaware River. Due to mechanical issues on the SHELBY, the
dredging operations will be attended by the towing vessel GRAPE APE for
the duration of the safety zone. All vessel contact information remains
the same.

DATES: This correction is effective without actual notice from November
13, 2017 until December 4, 2017. For the purpose of enforcement, actual
notice

will be used from November 6, 2017, until November 13, 2017.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Petty Officer Edmund Ofalt, Waterways Management Branch,
U.S. Coast Guard Sector Delaware bay; telephone<PHONE_NUMBER>, email
[email protected].

SUPPLEMENTARY INFORMATION: In FR Doc. 2017-24068, appearing at 82 FR
51347 on Monday, November 6, 2017, Sec.  165.T05-1011(c) incorrectly
references ``SHELBY'' instead of ``GRAPE APE.'' This document corrects
that error.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard corrects
33 CFR part 165 by making the following correcting amendment:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1,
6.04-6, and 160.5; Department of Homeland Security Delegation No.
0170.1.

Sec.  165.T05-1011  [Corrected]

0
2. In Sec.  165.T05-1011(c), remove ``SHELBY'' wherever it appears and
adding in its place ``GRAPE APE''.

    Dated: November 6, 2017.
Scott E. Anderson,
Captain, U.S. Coast Guard, Captain of the Port, Delaware Bay.
[FR Doc. 2017-24508 Filed 11-9-17; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 80, Number 89 (Friday, May 8, 2015)]
[Notices]
[Pages 26617-26618]
[FR Doc No: 2015-11104]

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

DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2015-0101, Notice No. 15-6]

International Standards on the Transport of Dangerous Goods

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: Notice of public meeting and request for information on
proposed alternative classification criteria for Class 8 (corrosive)
materials.

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

SUMMARY: This notice is to advise interested persons that on Wednesday,
June 10, 2015, PHMSA will conduct a public meeting to discuss proposals
in preparation for the 47th session of the United Nations Sub-Committee
of Experts on the Transport of Dangerous Goods (UNSCOE TDG) to be held
June 22 to June 26, 2015, in Geneva, Switzerland. During this meeting,
PHMSA is also soliciting comments relative to potential new work items
which may be considered for inclusion in its international agenda and
feedback on issues that PHMSA may put forward for consideration by the
Sub-Committee such as enhanced recognition of alternative test methods
relevant to the classification of corrosive materials (see further
discussion under the supplementary information section below). PHMSA
will also provide an update on recent actions to enhance transparency
and stakeholder interaction through improvements to the international
standards portion of its Web site.
    Also, on Wednesday, June 10, 2015, the Department of Labor,
Occupational Safety and Health Administration (OSHA) will conduct a
public meeting (see Docket No. OSHA-H022K-2006-0062) to discuss
proposals in preparation for the 29th session of the United Nations
Sub-Committee of Experts on the Globally Harmonized System of
Classification and Labelling of Chemicals (UNSCEGHS) to be held June 29
to July 1, 2015, in Geneva, Switzerland.
    Time and Location: Both meetings will be held at the DOT
Headquarters, West Building, 1200 New Jersey Avenue SE., Washington, DC
20590-0001.
    PHMSA public meeting: 9:00 a.m. to 12:00 noon EDT.
    OSHA public meeting: 1:00 p.m. to 4:00 p.m. EDT.
    Advanced Meeting Registration: The DOT requests that attendees pre-
register for these meetings by completing the form at https://www.surveymonkey.com/r/3XTD2TB. Attendees may use the same form to pre-
register for both the PHMSA and the OSHA meetings. Failure to pre-
register may delay your access to the DOT Headquarters building. If
participants are attending in person, arrive early to allow time for
security checks necessary to obtain access to the building.
    Conference call-in and ``live meeting'' capability will be provided
for both meetings. Specific information on call-in and live meeting
access will be posted when available at http://www.phmsa.dot.gov/hazmat/regs/international and at http://www.osha.gov/dsg/hazcom/.

FOR FURTHER INFORMATION CONTACT: Mr. Steven Webb or Mr. Aaron Wiener,
Office of Hazardous Materials Safety, Department of Transportation,
Washington, DC 20590; 202/366-8553.
    Supplementary Information on the PHMSA Meeting: The primary purpose
of PHMSA's meeting will be to prepare for the 47th session of the
UNSCOE TDG. The 47th session of the UNSCOE TDG is the first of four
meetings scheduled for the 2015-2016 biennium. The UNSCOE will consider
proposals for the 20th Revised Edition of the United Nations
Recommendations on the Transport of Dangerous Goods Model Regulations,
which may be implemented into relevant domestic, regional, and
international regulations from January 1, 2019. Copies of working
documents, informal documents, and the meeting agenda may be obtained
from the United Nations Transport Division's Web site at http://www.unece.org/trans/main/dgdb/dgsubc3/c3age.html.
    General topics on the agenda for the UNSCOE TDG meeting include:
     Explosives and related matters
     Listing, classification and packing
     Electric storage systems
     Transport of gases
     Miscellaneous pending issues
     Global harmonization of transport of dangerous goods
regulations with the Model Regulations
     Guiding principles for the Model Regulations
     Electronic data interchange for documentation purposes
     Cooperation with the International Atomic Energy Agency
(IAEA)
     New proposals for amendments to the Model Regulations
     Issues relating to the Globally Harmonized System of
Classification and Labeling of Chemicals (GHS)
    PHMSA specifically solicits comments relative to efforts by the UN
TDG and GHS Sub-Committees relevant to enhancing recognition of
additional Class 8 (corrosive) classification assessment methods that
are currently included within the GHS but not within the UN Model
Regulations for Transport. At its previous session the Sub-Committee
considered a U.S. proposal that addressed optional methods for
classification of mixtures based on pH and the use of ``bridging
principles'' consistent with the current GHS. During the meeting a
number of Sub-Committee members expressed support for the proposal in
principle, but suggested the proposal should also address use of the
``additivity'' classification method consistent with the GHS. Based on
comments received, PHMSA is considering submission of a revised
proposal including the additivity method as an additional option while
maintaining the methods addressed under the previous U.S. paper on this
topic (see http://www.unece.org/fileadmin/DAM/trans/doc/2014/dgac10c3/ST-SG-AC.10-C.3-2014-99_ST-SG-AC.10-C.4-2014-18e.pdf). PHMSA continues
to support the inclusion of alternative classification methods which
ensure an equivalent level of safety while reducing the need for in-
vitro and/or in-vivo testing where practicable. Comments on the Class 8
classification work, potential new work items which may be considered
for inclusion in PHMSA's international agenda, or any working documents
or informal documents to be considered at the 47th session of the
UNSCOE TDG may be provided in person at the public meeting or via email
to<EMAIL_ADDRESS>    Following the 47th session of the UNSCOE TDG, a copy of the Sub-
Committee's report will be available at the United Nations Transport
Division's Web site at http://www.unece.org/trans/main/dgdb/dgsubc3/c3rep.html. PHMSA's Web site at http://www.phmsa.dot.gov/hazmat/regs/international provides additional information regarding the UNSCOE TDG
and related matters.
    Supplementary Information on the OSHA Meeting: The Federal Register
notice and additional detailed information relating to OSHA's public
meeting will be available upon publication at http://www.regulations.gov (Docket No. OSHA-H022k-2006-0062) and on the OSHA
Web site at http://www.osha.gov/dsg/hazcom/.

    Signed at Washington, DC, on May 4, 2015.
Magdy El-Sibaie,
Associate Administrator for Hazardous Materials Safety.
[FR Doc. 2015-11104 Filed 5-7-15; 8:45 am]
 BILLING CODE 4910-60-P


[Federal Register Volume 85, Number 36 (Monday, February 24, 2020)]
[Proposed Rules]
[Pages 10344-10346]
[FR Doc No: 2020-03353]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 85, No. 36 / Monday, February 24, 2020 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-0101; Product Identifier 2019-NM-190-AD]
RIN 2120-AA64

Airworthiness Directives; De Havilland Aircraft of Canada Limited
(Type Certificate Previously Held by Bombardier, Inc.) 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 certain De Havilland Aircraft of Canada Limited Model DHC-8-400
series airplanes. This proposed AD was prompted by a report that
certain elevator power control unit (PCU) arm fittings have
nonconforming fillet radii. This proposed AD would require an
inspection for affected elevator PCU assemblies, inspections of
affected elevator PCU arm fittings for nonconforming fillet radii and
cracks, replacement if necessary, and re-identification of the affected
elevator PCU assemblies. 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 April 9,
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 De
Havilland Aircraft of Canada Limited, Q-Series Technical Help Desk, 123
Garratt Boulevard, Toronto, Ontario M3K 1Y5, Canada; phone: 416-375-
4000; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>internet: https://dehavilland.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 206-
231-3195.

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-2020-
0101; 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: Andrea Jimenez, Aerospace Engineer,
Airframe and Propulsion Section, FAA, New York ACO Branch, 1600 Stewart
Avenue, Suite 410, Westbury, NY 11590; phone:<PHONE_NUMBER>; fax: 516-
794-5531; 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-2020-0101;
Product Identifier 2019-NM-190-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, 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 the agency receives about this NPRM.

Discussion

    Transport Canada Civil Aviation (TCCA), which is the aviation
authority for Canada, has issued Canadian AD CF-2019-36, dated October
18, 2019 (``AD CF-2019-36'') (referred to after this as the Mandatory
Continuing Airworthiness Information, or ``the MCAI''), to correct an
unsafe condition for certain De Havilland Aircraft of Canada Limited
Model DHC-8-400 series airplanes. You may examine the MCAI in the AD
docket on the internet at https://www.regulations.gov by searching for
and locating Docket No. FAA-2020-0101.
    This proposed AD was prompted by a report that certain elevator PCU
arm fittings have nonconforming fillet radii. The FAA is proposing this
AD to address elevator PCU assemblies with nonconforming fillet radii,
which could lead to premature failure of the fitting and a jam in one
elevator; if the fittings on both elevators fail, a complete loss of
elevator control could occur. See the MCAI for additional background
information.

Related Service Information Under 1 CFR Part 51

    De Havilland has issued Service Bulletin 84-55-10, Revision A,
dated July 25, 2019. This service information describes procedures for
an inspection for affected elevator PCU assemblies, inspections of
affected elevator PCU arm fittings for nonconforming fillet radii and
cracks, replacement if necessary, and re-identification of the affected
elevator PCU assemblies. 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

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to the FAA's bilateral agreement with the State of Design Authority,
the FAA has been notified of the unsafe condition described in the MCAI
and service information referenced above. The FAA is proposing this AD
because the FAA

evaluated all the relevant information and determined the unsafe
condition described previously is likely to exist or develop on other
products of the same type design.

Proposed Requirements of This NPRM

    This proposed AD would require accomplishing the actions specified
in the service information described previously, except as discussed
under ``Differences Between this Proposed AD and the MCAI or Service
Information.''

Differences Between This Proposed AD and the MCAI or Service
Information

    Canadian AD CF-2019-36 specifies to do the required inspections
before accumulating 8,000 flight cycles from the effective date of
Canadian AD CF-2019-36, or before accumulating 30,000 total flight
cycles, whichever occurs first. TCCA's risk assessment was developed
using flight cycles on the elevator PCU assembly (which was
inadvertently omitted from the Canadian AD). The FAA has determined
that using the compliance times specified in the Canadian AD could
inadvertently ground certain airplanes. Therefore, the FAA finds that
the inspection must be accomplished within 8,000 flight cycles on the
elevator PCU assembly after the effective date of this AD, or before
the accumulation of 30,000 total flight cycles on the elevator PCU
assembly, whichever occurs first, which represents an appropriate
interval of time for affected airplanes to continue to operate without
compromising safety.

Costs of Compliance

    The FAA estimates that this proposed AD affects 38 airplanes of
U.S. registry. The FAA estimates the following costs to comply with
this proposed AD:

                                       Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
5 work-hours x $85 per hour = $425...........................              $0             $425          $16,150
----------------------------------------------------------------------------------------------------------------

    The FAA estimates the following costs to do any necessary on-
condition replacement that would be required based on the results of
any required inspections. The FAA has no way of determining the number
of aircraft that might need this on-condition replacement:

                                     Estimated Costs of On-Condition Actions
----------------------------------------------------------------------------------------------------------------
               Labor cost                            Parts cost                       Cost per product
----------------------------------------------------------------------------------------------------------------
14 work-hours x $85 per hour = $1,190...  Up to $9,060 ($1,510 per          Up to $10,250.
                                           elevator PCU arm fittings--6
                                           total per airplane).
----------------------------------------------------------------------------------------------------------------

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.

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):

De Havilland Aircraft of Canada Limited (Type Certificate Previously
Held by Bombardier, Inc.): Docket No. FAA-2020-0101; Product
Identifier 2019-NM-190-AD.

(a) Comments Due Date

    The FAA must receive comments by April 9, 2020.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to De Havilland Aircraft of Canada Limited Model
DHC-8-400, -401, and -402 series airplanes, certificated in any
category, serial numbers 4001 and subsequent.

(d) Subject

    Air Transport Association (ATA) of America Code 55, Stabilizers.

(e) Reason

    This AD was prompted by a report that certain elevator power
control unit (PCU) arm fittings have nonconforming fillet radii. The
FAA is issuing this AD to address elevator PCU assemblies with
nonconforming fillet radii, which could lead to premature failure of
the fitting and a jam in one elevator; if the fittings on both
elevators fail, a complete loss of elevator control could occur.

(f) Compliance

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

(g) Definition

    Affected elevator PCU assemblies are those having part number
85527021-005 or 85527021-006, and having serial number MMC4255
through MMC4276 inclusive.

(h) Inspections

    For airplanes having serial numbers 4001 through 4620 inclusive,
within 8,000 flight cycles on the elevator PCU assembly after the
effective date of this AD, or before the accumulation of 30,000
total flight cycles on the elevator PCU assembly, whichever occurs
first: Do the actions specified in paragraphs (h)(1) and (2) of this
AD.
    (1) Inspect to determine the part number and serial number of
each elevator PCU assembly installed on the airplane. A review of
airplane maintenance records is acceptable in lieu of this
inspection if the part number and serial number of the elevator PCU
assembly can be conclusively determined from that review.
    (2) If, during any inspection or records review required by
paragraph (h)(1) of this AD, any affected elevator PCU assembly is
found, do a detailed inspection of the elevator PCU arm fittings for
undersized fillet radii and cracks of the fillet radii in accordance
with Part A of the Accomplishment Instructions of de Havilland
Service Bulletin 84-55-10, Revision A, dated July 25, 2019. If no
undersized fillet radii or cracks of the fillet radii are found,
before further flight, re-identify the affected elevator PCU
assembly in accordance with the Accomplishment Instructions of de
Havilland Service Bulletin 84-55-10, Revision A, dated July 25,
2019.

(i) Corrective Actions

    If during any inspection of the elevator PCU arm fittings
required by paragraph (h)(2) of this AD, any undersized fillet radii
or cracks of the fillet radii are found, before further flight,
replace the elevator PCU arm fittings and re-identify each affected
elevator PCU assembly in accordance with Part B of the
Accomplishment Instructions of de Havilland Service Bulletin 84-55-
10, Revision A, dated July 25, 2019.

(j) Parts Installation Limitation

    As of the effective date of this AD, no person may install an
affected elevator PCU assembly, on any airplane, unless it has been
re-identified in accordance with the Accomplishment Instructions of
de Havilland Service Bulletin 84-55-10, Revision A, dated July 25,
2019.

(k) Credit for Previous Actions

    This paragraph provides credit for actions required by
paragraphs (h) and (i) of this AD, if those actions were performed
before the effective date of this AD using de Havilland Service
Bulletin 84-55-10, dated May 29, 2019.

(l) No Reporting Requirement

    Although de Havilland Service Bulletin 84-55-10, Revision A,
dated July 25, 2019, specifies to submit certain information to the
manufacturer, this AD does not include that requirement.

(m) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager, New
York 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 ATTN: Program Manager, Continuing Operational
Safety, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410,
Westbury, NY 11590; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>. 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.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, New York ACO
Branch, FAA; or Transport Canada Civil Aviation (TCCA); or De
Havilland Aircraft of Canada Limited's TCCA Design Approval
Organization (DAO). If approved by the DAO, the approval must
include the DAO-authorized signature.

(n) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) Canadian AD CF-2019-36, dated October 18, 2019, for related
information. This MCAI may be found in the AD docket on the internet
at https://www.regulations.gov by searching for and locating Docket
No. FAA-2020-0101.
    (2) For more information about this AD, contact Andrea Jimenez,
Aerospace Engineer, Airframe and Propulsion Section, FAA, New York
ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590;
phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (3) For service information identified in this AD, contact De
Havilland Aircraft of Canada Limited, Q-Series Technical Help Desk,
123 Garratt Boulevard, Toronto, Ontario M3K 1Y5, Canada; phone: 416-
375-4000; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>internet:
https://dehavilland.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 February 14, 2020.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2020-03353 Filed 2-21-20; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 144 (Wednesday, July 27, 2011)]
[Notices]
[Pages 44935-44936]
[FR Doc No: 2011-18923]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0453]

Draft Guidance for Industry and Food and Drug Administration
Staff; 510(k) Device Modifications: Deciding When To Submit a 510(k)
for a Change to an Existing Device; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``510(k) Device
Modifications: Deciding When To Submit a 510(k) for a Change to an
Existing Device.'' The recommendations in this guidance document are
intended to describe when a new 510(k) should be submitted for a change
or modification to a legally marketed device. This draft guidance is
not final nor is it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by October 25, 2011.

ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``510(k) Device Modifications: Deciding When
To Submit a 510(k) for a Change to an Existing Device'' to the Division
of Small Manufacturers, International, and Consumer Assistance, Center
for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist that office in
processing your request, or fax your request to<PHONE_NUMBER>. See the
SUPPLEMENTARY INFORMATION section for information on electronic access
to the guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Michael J. Ryan, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1615, Silver Spring, MD 20993-0002, 301-
796-6283.

SUPPLEMENTARY INFORMATION:

I. Background

    Since the amendment of the Federal Food, Drug, and Cosmetic Act by
the Medical Device Amendments of 1976, FDA has attempted to define with
greater clarity when a modification to an existing medical device would
trigger the requirement that a new premarket notification (510(k)) be
submitted to the Agency and cleared prior to marketing. FDA regulations
state in 21 CFR 807.81(a)(3) when a 510(k) must be submitted, but the
language used in this regulation sometimes leads to varying
interpretations of when a 510(k) is required for a device modification.
In order to address this issue, FDA issued in 1997 the guidance
document entitled ``Deciding When To Submit a 510(k) for a Change to an
Existing 510(k)''; however, regulatory changes such as the
implementation of the Quality System Regulation have occurred since
that time, and medical device technology has evolved.

    In addition, in September 2009, FDA convened an internal 510(k)
Working Group to conduct a comprehensive assessment of the 510(k)
process. The 510(k) Working Group evaluated the 510(k) program with the
goal of strengthening the program and improving the consistency in the
Agency's decisionmaking process. In August 2010, the Center for Devices
and Radiological Health (CDRH) published two documents in consideration
of the comments made at the public meeting and the Agency's preliminary
assessment of the program. These documents are titled ``CDRH
Preliminary Internal Evaluations--Volume I: 510(k) Working Group
Preliminary Report and Recommendations'' and ``CDRH Preliminary
Internal Evaluations--Volume II: Task Force on the Utilization of
Science in Regulatory Decision Making Preliminary Report and
Recommendations'' (http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/ucm239448.htm). In January 2011, CDRH published the ``Plan
of Action for Implementation of 510(k) and Science Recommendations''
(http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/UCM239450.pdf). One of the action items identified in the Plan of
Action included publication of an update to the 1997 Device
Modifications Guidance.
    The recommendations in this draft guidance document are consistent
with longstanding FDA policy for when a modification to a device does
and does not require the submission of a 510(k). The guidance has been
updated, however, to address issues associated with software and other
rapidly changing technologies, and to provide greater clarity about
changes that do not trigger the need for a new premarket submission.
This guidance uses examples of modifications to devices involving such
technologies to illustrate changes that require a new 510(k), and
changes that may simply be documented in accordance with a
manufacturer's existing Quality System without prompting the need for a
new 510(k) submission. FDA believes increased certainty about the
regulatory consequences of device modifications is critical to
facilitating advancements in device technology. FDA is specifically
interested in seeking comments on the changes described, types of
changes that are not covered by this document but should be, and
illustrative examples of types of changes.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on when a new
510(k) should be submitted for a change or modification to a legally
marketed device. It does not create or confer any rights for or on any
person and does not operate to bind FDA or the public. An alternative
approach may be used if such approach satisfies the requirements of the
applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. A search capability for all CDRH guidance
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. To receive
the draft guidance entitled ``510(k) Device Modifications: Deciding
When To Submit a 510(k) for a Change to an Existing Device,'' you may
either send an e-mail request to<EMAIL_ADDRESS>to receive an
electronic copy of the document or send a fax request to<PHONE_NUMBER>
to receive a hard copy. Please use the document number 1793 to identify
the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR 56.115 have been approved under
OMB control number 0910-0130; the collections of information in 21 CFR
part 801 have been approved under OMB control number 0910-0485; the
collections of information in 21 CFR part 803 have been approved under
OMB control number 0910-0437; 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 812 have been
approved under OMB control number 0910-0078; and the collections of
information in 21 CFR part 820 have been approved under OMB control
number 0910-0073.

V. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: July 21, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-18923 Filed 7-26-11; 8:45 am]
BILLING CODE 4160-01-P