Good Guidance Practices; Technical Amendment, 13415-13416 [2018-06252]

Download as PDF Federal Register / Vol. 83, No. 61 / Thursday, March 29, 2018 / Rules and Regulations Issued in Washington, DC on March 9, 2018. John S. Duncan, Director, Flight Standards Service. ODPs, effective at 0901 UTC on the dates specified, as follows: PART 97—STANDARD INSTRUMENT APPROACH PROCEDURES Adoption of the Amendment 1. The authority citation for part 97 continues to read as follows: ■ Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal regulations, Part 97, (14 CFR part 97), is amended by amending Standard Instrument Approach Procedures and Takeoff Minimums and AIRAC Date State Authority: 49 U.S.C. 106(f), 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721–44722. 2. Part 97 is amended to read as follows: ■ City Airport §§ 97.23, 97.25, 97.27, 97.29, 97.31, 97.33, 97.35 [Amended] By amending: § 97.23 VOR, VOR/ DME, VOR or TACAN, and VOR/DME or TACAN; § 97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; § 97.27 NDB, NDB/DME; § 97.29 ILS, ILS/DME, MLS, MLS/DME, MLS/RNAV; § 97.31 RADAR SIAPs; § 97.33 RNAV SIAPs; and § 97.35 COPTER SIAPs, Identified as follows: * * * Effective Upon Publication FDC No. FDC Date 26–Apr–18 .... 26–Apr–18 .... 26–Apr–18 .... WA OR CA Seattle ..................... Roseburg ................ Los Angeles ............ Seattle-Tacoma Intl ................. Roseburg Rgnl ........................ Los Angeles Intl ...................... 7/2572 7/4908 7/5971 3/1/18 2/20/18 3/1/18 26–Apr–18 .... CA Los Angeles ............ Los Angeles Intl ...................... 7/5981 3/1/18 26–Apr–18 26–Apr–18 26–Apr–18 26–Apr–18 26–Apr–18 .... .... .... .... .... MN MN MS IL CO Chandler Field ......................... Chandler Field ......................... Panola County ......................... General Downing—Peoria Intl Northern Colorado Rgnl .......... 7/9368 8/0189 8/0713 8/1895 8/2900 3/1/18 3/1/18 2/20/18 3/1/18 3/1/18 26–Apr–18 .... TX Alexandria ............... Alexandria ............... Batesville ................ Peoria ..................... Fort Collins/ Loveland. Crosbyton ............... Crosbyton Muni ....................... 8/3493 3/1/18 26–Apr–18 .... MI Lapeer ..................... Dupont-Lapeer ........................ 8/3495 3/1/18 26–Apr–18 .... TN Tri-Cities .................................. 8/3742 2/20/18 26–Apr–18 .... OH Bristol/Johnson/ Kingsport. Wooster .................. Wayne County ......................... 8/3745 3/1/18 26–Apr–18 .... KS Eureka .................... Lt William M Milliken ............... 8/3753 3/1/18 26–Apr–18 .... 26–Apr–18 .... MA ND New Bedford ........... Oakes ..................... New Bedford Rgnl ................... Oakes Muni ............................. 8/3764 8/3892 2/20/18 3/1/18 26–Apr–18 .... NV Reno ....................... Reno/Tahoe Intl ....................... 8/4030 2/20/18 26–Apr–18 .... NV Reno ....................... Reno/Tahoe Intl ....................... 8/4031 2/20/18 26–Apr–18 .... 26–Apr–18 .... MA WA Vineyard Haven ...... Pasco ...................... Martha’s Vineyard ................... Tri-Cities .................................. 8/5969 8/5970 3/1/18 3/1/18 BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 10 rmajette on DSKBCKNHB2PROD with RULES [Docket No. FDA–2018–N–1097] Good Guidance Practices; Technical Amendment AGENCY: Food and Drug Administration, HHS. Final rule; technical amendment. ACTION: VerDate Sep<11>2014 15:09 Mar 28, 2018 Jkt 244001 The Food and Drug Administration (FDA or Agency) is amending its good guidance practices regulation to inform the public on how to electronically submit a draft of a proposed guidance to the Agency. This technical amendment is nonsubstantive. DATES: This rule is effective March 29, 2018. FOR FURTHER INFORMATION CONTACT: Megan Velez, Office of Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4254, Silver Spring, MD 20993–0002, 301– 796–9301. SUPPLEMENTARY INFORMATION: FDA is amending 21 CFR 10.115(f)(3), good guidance regulations, by adding language on how the public can electronically submit drafts of proposed guidance documents to participate in SUMMARY: [FR Doc. 2018–06009 Filed 3–28–18; 8:45 am] PO 00000 Frm 00041 Fmt 4700 Sfmt 4700 13415 Subject ILS OR LOC RWY 34L, Amdt 1E VOR–A, Amdt 6 ILS OR LOC RWY 24L, Amdt 27A RNAV (GPS) Y RWY 24L, Amdt 5 VOR RWY 22, Amdt 15 RNAV (GPS) RWY 22 , Orig RNAV (GPS) RWY 19, Amdt 1 ILS OR LOC RWY 13, Amdt 6F Takeoff Minimums and Obstacle DP, Amdt 5 Takeoff Minimums and Obstacle DP, Orig Takeoff Minimums and Obstacle DP, Amdt 3 RNAV (GPS) RWY 23, Amdt 1C Takeoff Minimums and Obstacle DP, Amdt 1 Takeoff Minimums and Obstacle DP, Orig RNAV (GPS) RWY 14, Orig-B Takeoff Minimums and Obstacle DP, Amdt 1 ILS X OR LOC X RWY 16R, Orig-A ILS Z OR LOC Z RWY 16R, Orig-A ILS OR LOC RWY 24, Amdt 3A ILS OR LOC/DME RWY 21R, Amdt 13 the development and issuance of guidance documents. The amendment provides an option for submitting the draft of a proposed guidance to the Agency electronically through https:// www.regulations.gov at Docket No. FDA–2013–S–0610. Publication of this document constitutes final action on the change under the Administrative Procedure Act (5 U.S.C. 553). This technical amendment is nonsubstantive. FDA therefore, for good cause, has determined that notice and public comment are unnecessary under 5 U.S.C. 553(b)(3)(B). Further, this rule places no burden on affected parties for which such parties would need a reasonable time to prepare for the effective date of the rule. Accordingly, FDA, for good cause, has determined E:\FR\FM\29MRR1.SGM 29MRR1 13416 Federal Register / Vol. 83, No. 61 / Thursday, March 29, 2018 / Rules and Regulations this technical amendment to be exempt under 5 U.S.C. 553(d)(3) and that the rule can become effective upon publication. List of Subjects in 21 CFR Part 10 Administrative practice and procedure, News media. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 10 is amended as follows: PART 10—ADMINISTRATIVE PRACTICES AND PROCEDURES 1. The authority citation for part 10 continues to read as follows: ■ Authority: 5 U.S.C. 551–558, 701–706; 15 U.S.C. 1451–1461; 21 U.S.C. 141–149, 321– 397, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, 262, 263b, 264. 2. In § 10.115, add two sentences to the end of paragraph (f)(3) to read as follows: ■ § 10.115 Good guidance practices. * * * * * (f) * * * (3) * * * If you wish to submit the draft of a proposed guidance document electronically, submit it through https:// www.regulations.gov at Docket No. FDA–2013–S–0610. It is only necessary to submit one copy. * * * * * Dated: March 20, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–06252 Filed 3–28–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HOMELAND SECURITY Federal Emergency Management Agency 44 CFR Part 64 [Docket ID FEMA–2018–0002; Internal Agency Docket No. FEMA–8523] Suspension of Community Eligibility Federal Emergency Management Agency, DHS. ACTION: Final rule. AGENCY: This rule identifies communities where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP) that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain rmajette on DSKBCKNHB2PROD with RULES SUMMARY: VerDate Sep<11>2014 15:09 Mar 28, 2018 Jkt 244001 management requirements of the program. If the Federal Emergency Management Agency (FEMA) receives documentation that the community has adopted the required floodplain management measures prior to the effective suspension date given in this rule, the suspension will not occur and a notice of this will be provided by publication in the Federal Register on a subsequent date. Also, information identifying the current participation status of a community can be obtained from FEMA’s Community Status Book (CSB). The CSB is available at https:// www.fema.gov/national-floodinsurance-program-community-statusbook. DATES: The effective date of each community’s scheduled suspension is the third date (‘‘Susp.’’) listed in the third column of the following tables. FOR FURTHER INFORMATION CONTACT: If you want to determine whether a particular community was suspended on the suspension date or for further information, contact Adrienne L. Sheldon, PE, CFM, Federal Insurance and Mitigation Administration, Federal Emergency Management Agency, 400 C Street SW, Washington, DC 20472, (202) 212–3966. SUPPLEMENTARY INFORMATION: The NFIP enables property owners to purchase Federal flood insurance that is not otherwise generally available from private insurers. In return, communities agree to adopt and administer local floodplain management measures aimed at protecting lives and new construction from future flooding. Section 1315 of the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits the sale of NFIP flood insurance unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed in this document no longer meet that statutory requirement for compliance with program regulations, 44 CFR part 59. Accordingly, the communities will be suspended on the effective date in the third column. As of that date, flood insurance will no longer be available in the community. We recognize that some of these communities may adopt and submit the required documentation of legally enforceable floodplain management measures after this rule is published but prior to the actual suspension date. These communities will not be suspended and will continue to be eligible for the sale of NFIP flood insurance. A notice withdrawing the suspension of such communities will be published in the Federal Register. PO 00000 Frm 00042 Fmt 4700 Sfmt 4700 In addition, FEMA publishes a Flood Insurance Rate Map (FIRM) that identifies the Special Flood Hazard Areas (SFHAs) in these communities. The date of the FIRM, if one has been published, is indicated in the fourth column of the table. No direct Federal financial assistance (except assistance pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act not in connection with a flood) may be provided for construction or acquisition of buildings in identified SFHAs for communities not participating in the NFIP and identified for more than a year on FEMA’s initial FIRM for the community as having flood-prone areas (section 202(a) of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against certain types of Federal assistance becomes effective for the communities listed on the date shown in the last column. The Administrator finds that notice and public comment procedures under 5 U.S.C. 553(b), are impracticable and unnecessary because communities listed in this final rule have been adequately notified. Each community receives 6-month, 90-day, and 30-day notification letters addressed to the Chief Executive Officer stating that the community will be suspended unless the required floodplain management measures are met prior to the effective suspension date. Since these notifications were made, this final rule may take effect within less than 30 days. National Environmental Policy Act. FEMA has determined that the community suspension(s) included in this rule is a non-discretionary action and therefore the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.) does not apply. Regulatory Flexibility Act. The Administrator has determined that this rule is exempt from the requirements of the Regulatory Flexibility Act because the National Flood Insurance Act of 1968, as amended, Section 1315, 42 U.S.C. 4022, prohibits flood insurance coverage unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed no longer comply with the statutory requirements, and after the effective date, flood insurance will no longer be available in the communities unless remedial action takes place. Regulatory Classification. This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, E:\FR\FM\29MRR1.SGM 29MRR1

Agencies

[Federal Register Volume 83, Number 61 (Thursday, March 29, 2018)]
[Rules and Regulations]
[Pages 13415-13416]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06252]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 10

[Docket No. FDA-2018-N-1097]


Good Guidance Practices; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is amending 
its good guidance practices regulation to inform the public on how to 
electronically submit a draft of a proposed guidance to the Agency. 
This technical amendment is nonsubstantive.

DATES: This rule is effective March 29, 2018.

FOR FURTHER INFORMATION CONTACT: Megan Velez, Office of Policy, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4254, 
Silver Spring, MD 20993-0002, 301-796-9301.

SUPPLEMENTARY INFORMATION: FDA is amending 21 CFR 10.115(f)(3), good 
guidance regulations, by adding language on how the public can 
electronically submit drafts of proposed guidance documents to 
participate in the development and issuance of guidance documents. The 
amendment provides an option for submitting the draft of a proposed 
guidance to the Agency electronically through https://www.regulations.gov at Docket No. FDA-2013-S-0610.
    Publication of this document constitutes final action on the change 
under the Administrative Procedure Act (5 U.S.C. 553). This technical 
amendment is nonsubstantive. FDA therefore, for good cause, has 
determined that notice and public comment are unnecessary under 5 
U.S.C. 553(b)(3)(B). Further, this rule places no burden on affected 
parties for which such parties would need a reasonable time to prepare 
for the effective date of the rule. Accordingly, FDA, for good cause, 
has determined

[[Page 13416]]

this technical amendment to be exempt under 5 U.S.C. 553(d)(3) and that 
the rule can become effective upon publication.

List of Subjects in 21 CFR Part 10

    Administrative practice and procedure, News media.

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

PART 10--ADMINISTRATIVE PRACTICES AND PROCEDURES

0
1. The authority citation for part 10 continues to read as follows:

    Authority:  5 U.S.C. 551-558, 701-706; 15 U.S.C. 1451-1461; 21 
U.S.C. 141-149, 321-397, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 
U.S.C. 201, 262, 263b, 264.


0
2. In Sec.  10.115, add two sentences to the end of paragraph (f)(3) to 
read as follows:


Sec.  10.115   Good guidance practices.

* * * * *
    (f) * * *
    (3) * * * If you wish to submit the draft of a proposed guidance 
document electronically, submit it through https://www.regulations.gov 
at Docket No. FDA-2013-S-0610. It is only necessary to submit one copy.
* * * * *

    Dated: March 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06252 Filed 3-28-18; 8:45 am]
 BILLING CODE 4164-01-P

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