83_FR_12345 83 FR 12290 - Proposed Amendment of Air Traffic Service (ATS) Route Q-5; Western United States

83 FR 12290 - Proposed Amendment of Air Traffic Service (ATS) Route Q-5; Western United States

DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration

Federal Register Volume 83, Issue 55 (March 21, 2018)

Page Range12290-12292
FR Document2018-05584

This action proposes to amend United States Area Navigation (RNAV) route Q-5 in the western United States. The route will now terminate at a waypoint (WP) that connects to an Oakland International Airport (OAK), Standard Terminal Arrival Route (STAR) near Oakland CA.

Federal Register, Volume 83 Issue 55 (Wednesday, March 21, 2018) 
[Federal Register Volume 83, Number 55 (Wednesday, March 21, 2018)]
[Proposed Rules]
[Pages 12290-12292]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-05584]


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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2018-0195; Airspace Docket No. 17-AWP-15]


Proposed Amendment of Air Traffic Service (ATS) Route Q-5; 
Western United States

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to amend United States Area Navigation 
(RNAV) route Q-5 in the western United States. The route will now 
terminate at a waypoint (WP) that connects to an Oakland International 
Airport (OAK), Standard Terminal Arrival Route (STAR) near Oakland CA.

DATES: Comments must be received on or before May 7, 2018.

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: 
1(800) 647-5527, or (202) 366-9826. You must identify FAA Docket No. 
FAA-2018-0195 and Airspace Docket No. 17-AWP-15 at the beginning of 
your comments. You may also submit comments through the internet at 
http://www.regulations.gov.
    FAA Order 7400.11B, Airspace Designations and Reporting Points, and 
subsequent amendments can be viewed online at http://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 7400.11B at NARA, call (202) 741-6030, or go 
to https://www.archives.gov/federal-register/cfr/ibr-locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is 
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: Kenneth Ready, Airspace Policy Group, 
Office of Airspace Services, Federal Aviation Administration, 800 
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

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 
the 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 modify the route structure as necessary to 
support the safe and efficient flow of air traffic within the National 
Airspace System.

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

[[Page 12291]]

regulatory, aeronautical, economic, environmental, and energy-related 
aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No. 
FAA-2018-0195 and Airspace Docket No. 17-AWP-15) and be submitted in 
triplicate to the Docket Management Facility (see ADDRESSES section for 
address and phone number). You may also submit comments through the 
internet at http://www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments 
on this action must submit with those comments a self-addressed, 
stamped postcard on which the following statement is made: ``Comments 
to FAA Docket No. FAA-2018-0195, and Airspace Docket No. 17-AWP-15.'' 
The postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified comment 
closing date will be considered before taking action on the proposed 
rule. The proposal contained in this action may be changed in light of 
comments received. All comments submitted will be available for 
examination in the public docket both before and after the comment 
closing date. 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 http://www.regulations.gov. Recently published rulemaking 
documents can also be accessed through the FAA's web page at http://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 ADDRESSES section for 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 during normal 
business hours at the office of the Western Service Center, Operations 
Support Group, Federal Aviation Administration, 2200 South 216th St., 
Des Moines, WA 98198.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11B, airspace 
Designations and Reporting Points, dated August 3, 2017, and effective 
September 15, 2017. FAA Order 7400.11B is publicly available as listed 
in the ADDRESSES section of this document. FAA Order 7400.11B lists 
Class A, B, C, D, and E airspace areas, air traffic service routes, and 
reporting points.

Background

    Route Q-5 was one of the original RNAV routes developed ushering in 
performance based navigation (PBN) into the United States. Route Q-5 
provided a high altitude route from Seattle into the bay area of San 
Francisco and Oakland, CA. Route Q-5 tied in OAK airport via the RAIDR 
STAR from STIKM WP, which is the current southern boundary point on the 
route. The STAR was removed in 2017 and Q-5 no longer tied into the bay 
area. The FAA proposes to add a new boundary point of SPAMY, CA, WP, 
which serves two STARs; WNDSR TWO ARRIVAL and the AANET ONE ARRIVAL, 
with both serving OAK. Lastly, policy states odd numbered ATS routes 
list points south to north. Currently Q-5 lists the route north to 
south. This proposal corrects the direction and will be in line with 
current policy.

The Proposal

    The FAA is proposing an amendment to Title 14, Code of Federal 
Regulations (14 CFR) part 71 to modify RNAV route Q-5. The proposed 
route changes are outlined below. Q-5: Route Q-5 currently extends from 
HAROB, WA to STIKM, CA. The FAA proposes to start the route at SPAMY, 
CA, WP, thereby eliminating the STIKM, CA, WP and the HUPTU, CA, WP, to 
support STARs into OAK. Additionally, ATS route policy states, odd 
numbered routes will be listed south to north. Route Q-5 was originally 
listed north to south, and is proposed south to north. The amended 
route would, therefore, extend from SPAMY, CA to HAROB, WA.
    United States Area Navigation Routes are published in paragraph 
2006 of FAA Order 7400.11B dated August 3, 2017, and effective 
September 15, 2017, which is incorporated by reference in 14 CFR 71.1. 
The United States Area Navigation Routes listed in this document will 
be subsequently published in the Order.

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. 
It, therefore: (1) Is not a ``significant regulatory action'' under 
Executive Order 12866; (2) is not a ``significant rule'' under 
Department of Transportation (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. 
Since this is a routine matter that will only affect air traffic 
procedures and air navigation, it is certified that this proposed rule, 
when promulgated, will 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

    In consideration of the foregoing, 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 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 7400.11B, 
Airspace Designations and Reporting Points, dated August 3, 2017 and 
effective September 15, 2017, is amended as follows:

Paragraph 2006 United States Area Navigation Routes

[[Page 12292]]



Q-5 SPAMY, CA to HAROB, WA [Amended]
 
SPAMY, CA               WP                     (Lat. 39[deg]11'57.00'' N, long. 122[deg]37'58.00'' W)
HOMEG, CA               WP                     (Lat. 41[deg]20'09.00'' N, long. 122[deg]51'05.00'' W)
HARPR, OR               WP                     (Lat. 42[deg]28'50.00'' N, long. 122[deg]53'01.54'' W)
HISKU, OR               WP                     (Lat. 44[deg]30'00.00'' N, long. 122[deg]56'39.00'' W)
HAROB, WA               WP                     (Lat. 47[deg]14'36.00'' N, long. 123[deg]02'27.00'' W)
 


    Issued in Washington, DC, on March 13, 2018.
Rodger A. Dean Jr.,
Manager, Airspace Policy Group.
[FR Doc. 2018-05584 Filed 3-20-18; 8:45 am]
BILLING CODE 4910-13-P

12290 Federal Register / Vol. 83, No. 55 / Wednesday, March 21, 2018 / Proposed Rules operations in standard instrument Points, dated August 3, 2017, and No. 17–AWP–15 at the beginning of approach and departure procedures at effective September 15, 2017, is your comments. You may also submit the airport. amended as follows: comments through the internet at http:// Class E airspace designations are www.regulations.gov. Paragraph 6005 Class E Airspace Areas published in paragraph 6005 of FAA Extending Upward From 700 Feet or More FAA Order 7400.11B, Airspace Order 7400.11B, dated August 3, 2017, Above the Surface of the Earth. Designations and Reporting Points, and and effective September 15, 2017, which subsequent amendments can be viewed * * * * * is incorporated by reference in 14 CFR online at http://www.faa.gov/air_traffic/ 71.1. The Class E airspace designations AWP AS E5 Pago Pago, AS [New] publications/. For further information, listed in this document will be Pago Pago International Airport, American you can contact the Airspace Policy published subsequently in the Order. Samoa Group, Federal Aviation (Lat. 14°19′54″ N, long. 170°42′41″ W) Administration, 800 Independence Regulatory Notices and Analyses That airspace extending upward from 700 Avenue SW, Washington, DC 20591; The FAA has determined that this feet above the surface within a 7-mile radius telephone: (202) 267–8783. The Order is regulation only involves an established of Pago Pago International Airport and within also available for inspection at the body of technical regulations for which 4 miles either side of the 071° bearing of the Pago Pago International Airport, extending National Archives and Records frequent and routine amendments are Administration (NARA). For necessary to keep them operationally from the 7-mile radius to 10.6 miles northeast of the airport, and within 4 miles either side information on the availability of FAA current, is non-controversial and Order 7400.11B at NARA, call (202) of the 240° bearing of the airport extending unlikely to result in adverse or negative from the 7-mile radius to 10.4 miles 741–6030, or go to https:// comments. It, therefore: (1) Is not a southwest of the airport; and that airspace www.archives.gov/federal-register/cfr/ ‘‘significant regulatory action’’ under extending upward from 1,200 feet above the ibr-locations.html. Executive Order 12866; (2) is not a surface within a 20 mile-radius of Pago Pago FAA Order 7400.11, Airspace ‘‘significant rule’’ under DOT International Airport, excluding that airspace Designations and Reporting Points, is Regulatory Policies and Procedures (44 extending beyond 12 miles of the shoreline. published yearly and effective on FR 11034; February 26, 1979); and (3) Issued in Washington, DC, on March 12, September 15. does not warrant preparation of a 2018. regulatory evaluation as the anticipated FOR FURTHER INFORMATION CONTACT: Rodger A. Dean Jr., impact is so minimal. Since this is a Kenneth Ready, Airspace Policy Group, Manager, Airspace Policy Group. routine matter that will only affect air Office of Airspace Services, Federal [FR Doc. 2018–05585 Filed 3–20–18; 8:45 am] Aviation Administration, 800 traffic procedures and air navigation, it BILLING CODE 4910–13–P is certified that this rule, when Independence Avenue SW, Washington, promulgated, will not have a significant DC 20591; telephone: (202) 267–8783. economic impact on a substantial DEPARTMENT OF TRANSPORTATION SUPPLEMENTARY INFORMATION: number of small entities under the Authority for This Rulemaking criteria of the Regulatory Flexibility Act. Federal Aviation Administration The FAA’s authority to issue rules Environmental Review regarding aviation safety is found in 14 CFR Part 71 This proposal will be subject to an Title 49 of the United States Code. environmental analysis in accordance [Docket No. FAA–2018–0195; Airspace Subtitle I, Section 106 describes the Docket No. 17–AWP–15] with FAA Order 1050.1F, authority of the FAA Administrator. ‘‘Environmental Impacts: Policies and Proposed Amendment of Air Traffic Subtitle VII, Aviation Programs, Procedures’’ prior to any FAA final Service (ATS) Route Q–5; Western describes in more detail the scope of the regulatory action. United States agency’s authority. This rulemaking is promulgated under the authority List of Subjects in 14 CFR Part 71 AGENCY: Federal Aviation described in Subtitle VII, Part A, Airspace, Incorporation by reference, Administration (FAA), DOT. Subpart I, Section 40103. Under that Navigation (air). ACTION: Notice of proposed rulemaking section, the FAA is charged with The Proposed Amendment (NPRM). prescribing regulations to assign the use of the airspace necessary to ensure the In consideration of the foregoing, the SUMMARY: This action proposes to safety of aircraft and the efficient use of Federal Aviation Administration amend United States Area Navigation airspace. This regulation is within the proposes to amend 14 CFR part 71 as (RNAV) route Q–5 in the western scope of that authority as it would follows: United States. The route will now modify the route structure as necessary terminate at a waypoint (WP) that to support the safe and efficient flow of PART 71—DESIGNATION OF CLASS A, connects to an Oakland International B, C, D, AND E AIRSPACE AREAS; AIR air traffic within the National Airspace Airport (OAK), Standard Terminal System. TRAFFIC SERVICE ROUTES; AND Arrival Route (STAR) near Oakland CA. REPORTING POINTS DATES: Comments must be received on Comments Invited ■ 1. The authority citation for 14 CFR or before May 7, 2018. Interested parties are invited to ADDRESSES: Send comments on this participate in this proposed rulemaking sradovich on DSK3GMQ082PROD with PROPOSALS part 71 continues to read as follows: proposal to the U.S. Department of by submitting such written data, views, Authority: 49 U.S.C. 106(f), 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, Transportation, Docket Operations, 1200 or arguments as they may desire. 1959–1963 Comp., p. 389. New Jersey Avenue SE, West Building Comments that provide the factual basis Ground Floor, Room W12–140, supporting the views and suggestions § 71.1 [Amended] Washington, DC 20590; telephone: presented are particularly helpful in ■ 2. The incorporation by reference in 1(800) 647–5527, or (202) 366–9826. developing reasoned regulatory 14 CFR 71.1 of FAA Order 7400.11B, You must identify FAA Docket No. decisions on the proposal. Comments Airspace Designations and Reporting FAA–2018–0195 and Airspace Docket are specifically invited on the overall VerDate Sep<11>2014 17:00 Mar 20, 2018 Jkt 244001 PO 00000 Frm 00008 Fmt 4702 Sfmt 4702 E:\FR\FM\21MRP1.SGM 21MRP1

Federal Register / Vol. 83, No. 55 / Wednesday, March 21, 2018 / Proposed Rules 12291 regulatory, aeronautical, economic, Designations and Reporting Points, established body of technical environmental, and energy-related dated August 3, 2017, and effective regulations for which frequent and aspects of the proposal. September 15, 2017. FAA Order routine amendments are necessary to Communications should identify both 7400.11B is publicly available as listed keep them operationally current. It, docket numbers (FAA Docket No. FAA– in the ADDRESSES section of this therefore: (1) Is not a ‘‘significant 2018–0195 and Airspace Docket No. 17– document. FAA Order 7400.11B lists regulatory action’’ under Executive AWP–15) and be submitted in triplicate Class A, B, C, D, and E airspace areas, Order 12866; (2) is not a ‘‘significant to the Docket Management Facility (see air traffic service routes, and reporting rule’’ under Department of ADDRESSES section for address and points. Transportation (DOT) Regulatory phone number). You may also submit Background Policies and Procedures (44 FR 11034; comments through the internet at http:// www.regulations.gov. February 26, 1979); and (3) does not Route Q–5 was one of the original Commenters wishing the FAA to warrant preparation of a regulatory RNAV routes developed ushering in acknowledge receipt of their comments performance based navigation (PBN) evaluation as the anticipated impact is on this action must submit with those into the United States. Route Q–5 so minimal. Since this is a routine comments a self-addressed, stamped provided a high altitude route from matter that will only affect air traffic postcard on which the following Seattle into the bay area of San procedures and air navigation, it is statement is made: ‘‘Comments to FAA Francisco and Oakland, CA. Route Q–5 certified that this proposed rule, when Docket No. FAA–2018–0195, and tied in OAK airport via the RAIDR promulgated, will not have a significant Airspace Docket No. 17–AWP–15.’’ The STAR from STIKM WP, which is the economic impact on a substantial postcard will be date/time stamped and current southern boundary point on the number of small entities under the returned to the commenter. route. The STAR was removed in 2017 criteria of the Regulatory Flexibility Act. All communications received on or and Q–5 no longer tied into the bay before the specified comment closing Environmental Review area. The FAA proposes to add a new date will be considered before taking boundary point of SPAMY, CA, WP, action on the proposed rule. The This proposal will be subject to an which serves two STARs; WNDSR TWO environmental analysis in accordance proposal contained in this action may ARRIVAL and the AANET ONE be changed in light of comments with FAA Order 1050.1F, ARRIVAL, with both serving OAK. ‘‘Environmental Impacts: Policies and received. All comments submitted will Lastly, policy states odd numbered ATS be available for examination in the Procedures’’ prior to any FAA final routes list points south to north. regulatory action. public docket both before and after the Currently Q–5 lists the route north to comment closing date. A report south. This proposal corrects the List of Subjects in 14 CFR Part 71 summarizing each substantive public direction and will be in line with contact with FAA personnel concerned current policy. Airspace, Incorporation by reference, with this rulemaking will be filed in the Navigation (air). docket. The Proposal The Proposed Amendment Availability of NPRMs The FAA is proposing an amendment An electronic copy of this document to Title 14, Code of Federal Regulations In consideration of the foregoing, the may be downloaded through the (14 CFR) part 71 to modify RNAV route Federal Aviation Administration internet at http://www.regulations.gov. Q–5. The proposed route changes are proposes to amend 14 CFR part 71 as Recently published rulemaking outlined below. Q–5: Route Q–5 follows: documents can also be accessed through currently extends from HAROB, WA to the FAA’s web page at http:// STIKM, CA. The FAA proposes to start PART 71—DESIGNATION OF CLASS A, www.faa.gov/air_traffic/publications/ the route at SPAMY, CA, WP, thereby B, C, D, AND E AIRSPACE AREAS; AIR airspace_amendments/. eliminating the STIKM, CA, WP and the TRAFFIC SERVICE ROUTES; AND You may review the public docket HUPTU, CA, WP, to support STARs into REPORTING POINTS containing the proposal, any comments OAK. Additionally, ATS route policy received and any final disposition in states, odd numbered routes will be ■ 1. The authority citation for part 71 person in the Dockets Office (see listed south to north. Route Q–5 was continues to read as follows: ADDRESSES section for address and originally listed north to south, and is proposed south to north. The amended Authority: 49 U.S.C. 106(f), 106(g); 40103, phone number) between 9:00 a.m. and route would, therefore, extend from 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 5:00 p.m., Monday through Friday, SPAMY, CA to HAROB, WA. 1959–1963 Comp., p. 389. except Federal holidays. An informal docket may also be examined during United States Area Navigation Routes § 71.1 [Amended] normal business hours at the office of are published in paragraph 2006 of FAA the Western Service Center, Operations Order 7400.11B dated August 3, 2017, ■ 2. The incorporation by reference in Support Group, Federal Aviation and effective September 15, 2017, which 14 CFR 71.1 of FAA Order 7400.11B, Administration, 2200 South 216th St., is incorporated by reference in 14 CFR Airspace Designations and Reporting Des Moines, WA 98198. 71.1. The United States Area Navigation Points, dated August 3, 2017 and Routes listed in this document will be effective September 15, 2017, is sradovich on DSK3GMQ082PROD with PROPOSALS Availability and Summary of subsequently published in the Order. amended as follows: Documents for Incorporation by Reference Regulatory Notices and Analyses Paragraph 2006 United States Area This document proposes to amend The FAA has determined that this Navigation Routes FAA Order 7400.11B, airspace proposed regulation only involves an VerDate Sep<11>2014 17:00 Mar 20, 2018 Jkt 244001 PO 00000 Frm 00009 Fmt 4702 Sfmt 4702 E:\FR\FM\21MRP1.SGM 21MRP1

12292 Federal Register / Vol. 83, No. 55 / Wednesday, March 21, 2018 / Proposed Rules Q–5 SPAMY, CA to HAROB, WA [Amended] SPAMY, CA WP (Lat. 39°11′57.00″ N, long. 122°37′58.00″ W) HOMEG, CA WP (Lat. 41°20′09.00″ N, long. 122°51′05.00″ W) HARPR, OR WP (Lat. 42°28′50.00″ N, long. 122°53′01.54″ W) HISKU, OR WP (Lat. 44°30′00.00″ N, long. 122°56′39.00″ W) HAROB, WA WP (Lat. 47°14′36.00″ N, long. 123°02′27.00″ W) Issued in Washington, DC, on March 13, Agency guidances at any time as a.m. and 4 p.m., Monday through 2018. follows: Friday. Rodger A. Dean Jr., • Confidential Submissions—To Manager, Airspace Policy Group. Electronic Submissions submit a comment with confidential [FR Doc. 2018–05584 Filed 3–20–18; 8:45 am] Submit electronic comments in the information that you do not wish to be BILLING CODE 4910–13–P following way: made publicly available, submit your • Federal eRulemaking Portal: comments only as a written/paper https://www.regulations.gov. Follow the submission. You should submit two DEPARTMENT OF HEALTH AND instructions for submitting comments. copies total. One copy will include the HUMAN SERVICES Comments submitted electronically, information you claim to be confidential including attachments, to https:// with a heading or cover note that states Food and Drug Administration www.regulations.gov will be posted to ‘‘THIS DOCUMENT CONTAINS the docket unchanged. Because your CONFIDENTIAL INFORMATION.’’ The 21 CFR Part 4 comment will be made public, you are Agency will review this copy, including solely responsible for ensuring that your the claimed confidential information, in [Docket No. FDA–2008–N–0424] its consideration of comments. The comment does not include any Postmarketing Safety Reporting for confidential information that you or a second copy, which will have the Combination Products; Draft Guidance third party may not wish to be posted, claimed confidential information for Industry and Food and Drug such as medical information, your or redacted/blacked out, will be available Administration Staff; Availability anyone else’s Social Security number, or for public viewing and posted on confidential business information, such https://www.regulations.gov. Submit AGENCY: Food and Drug Administration, both copies to the Dockets Management as a manufacturing process. Please note HHS. Staff. If you do not wish your name and that if you include your name, contact ACTION: Notification of availability. information, or other information that contact information to be made publicly identifies you in the body of your available, you can provide this SUMMARY: The Food and Drug information on the cover sheet and not Administration (FDA or Agency) is comments, that information will be posted on https://www.regulations.gov. in the body of your comments and you announcing the availability of a draft must identify this information as guidance for industry and FDA staff • If you want to submit a comment ‘‘confidential.’’ Any information marked entitled ‘‘Postmarketing Safety with confidential information that you as ‘‘confidential’’ will not be disclosed Reporting for Combination Products.’’ do not wish to be made available to the except in accordance with 21 CFR 10.20 This draft guidance addresses certain public, submit the comment as a and other applicable disclosure law. For means by which applicants may comply written/paper submission and in the more information about FDA’s posting with the final rule on postmarketing manner detailed (see ‘‘Written/Paper of comments to public dockets, see 80 safety reporting (PMSR) requirements Submissions’’ and ‘‘Instructions’’). FR 56469, September 18, 2015, or access for combination products that FDA Written/Paper Submissions the information at: https://www.gpo.gov/ issued on December 20, 2016. fdsys/pkg/FR-2015-09-18/pdf/2015- Combination products are products Submit written/paper submissions as 23389.pdf. composed of two or more different types follows: Docket: For access to the docket to of medical products (drug, device, and/ • Mail/Hand delivery/Courier (for read background documents or the or biological product). Although the written/paper submissions): Dockets electronic and written/paper comments PMSR regulations for drugs, devices, Management Staff (HFA–305), Food and received, go to https:// and biological products share many Drug Administration, 5630 Fishers www.regulations.gov and insert the similarities, each set of regulations Lane, Rm. 1061, Rockville, MD 20852. docket number, found in brackets in the establishes distinct postmarketing • For written/paper comments heading of this document, into the reporting requirements, standards, and submitted to the Dockets Management ‘‘Search’’ box and follow the prompts timeframes. The final rule provides Staff, FDA will post your comment, as and/or go to the Dockets Management clarity on the PMSR requirements for well as any attachments, except for Staff, 5630 Fishers Lane, Rm. 1061, combination products to ensure information submitted, marked and Rockville, MD 20852. consistent and complete reporting while identified, as confidential, if submitted You may submit comments on any avoiding duplication. This draft as detailed in ‘‘Instructions.’’ guidance at any time (see 21 CFR guidance is not final nor is it in effect Instructions: All submissions received 10.115(g)(5)). at this time. must include the Docket No. FDA– Submit written requests for single sradovich on DSK3GMQ082PROD with PROPOSALS DATES: Submit either electronic or 2008–N–0424 for ‘‘Postmarket Safety copies of the draft guidance to the Office written comments on the draft guidance Reporting for Combination Products.’’ of Combination Products, Food and by June 19, 2018 to ensure that the Received comments will be placed in Drug Administration, Bldg. 32, Rm. Agency considers your comment on this the docket and, except for those 5129, 10903 New Hampshire Ave., draft guidance before it begins work on submitted as ‘‘Confidential Silver Spring, MD 20993. Send two self- the final version of the guidance. Submissions,’’ publicly viewable at addressed adhesive label to assist that ADDRESSES: You may submit either https://www.regulations.gov or at the office in processing your requests. See electronic or written comments on any Dockets Management Staff between 9 the SUPPLEMENTARY INFORMATION section VerDate Sep<11>2014 17:00 Mar 20, 2018 Jkt 244001 PO 00000 Frm 00010 Fmt 4702 Sfmt 4702 E:\FR\FM\21MRP1.SGM 21MRP1


Document Created: 2018-03-21 00:45:34
Document Modified: 2018-03-21 00:45:34
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionNotice of proposed rulemaking (NPRM).
DatesComments must be received on or before May 7, 2018.
ContactKenneth Ready, Airspace Policy Group, Office of Airspace Services, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267- 8783.
FR Citation83 FR 12290 
CFR AssociatedAirspace; Incorporation by Reference and Navigation (air)
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