83 FR 13415 - Good Guidance Practices; Technical Amendment

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 61 (March 29, 2018)

Page Range		13415-13416
FR Document		2018-06252

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.

Federal Register, Volume 83 Issue 61 (Thursday, March 29, 2018)

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


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

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

Federal Register / Vol. 83, No. 61 / Thursday, March 29, 2018 / Rules and Regulations 13415

Issued in Washington, DC on March 9, ODPs, effective at 0901 UTC on the §§ 97.23, 97.25, 97.27, 97.29, 97.31, 97.33,
2018. dates specified, as follows: 97.35 [Amended]
John S. Duncan, By amending: § 97.23 VOR, VOR/
PART 97—STANDARD INSTRUMENT
Director, Flight Standards Service. DME, VOR or TACAN, and VOR/DME
APPROACH PROCEDURES
Adoption of the Amendment or TACAN; § 97.25 LOC, LOC/DME,
■ 1. The authority citation for part 97 LDA, LDA/DME, SDF, SDF/DME;
Accordingly, pursuant to the continues to read as follows: § 97.27 NDB, NDB/DME; § 97.29 ILS,
authority delegated to me, Title 14, ILS/DME, MLS, MLS/DME, MLS/RNAV;
Authority: 49 U.S.C. 106(f), 106(g), 40103,
Code of Federal regulations, Part 97, (14 40106, 40113, 40114, 40120, 44502, 44514,
§ 97.31 RADAR SIAPs; § 97.33 RNAV
CFR part 97), is amended by amending 44701, 44719, 44721–44722. SIAPs; and § 97.35 COPTER SIAPs,
Standard Instrument Approach Identified as follows:
■ 2. Part 97 is amended to read as
Procedures and Takeoff Minimums and follows: * * * Effective Upon Publication

AIRAC Date State City Airport FDC No. FDC Date Subject

26–Apr–18 .... WA Seattle ..................... Seattle-Tacoma Intl ................. 7/2572 3/1/18 ILS OR LOC RWY 34L, Amdt 1E
26–Apr–18 .... OR Roseburg ................ Roseburg Rgnl ........................ 7/4908 2/20/18 VOR–A, Amdt 6
26–Apr–18 .... CA Los Angeles ............ Los Angeles Intl ...................... 7/5971 3/1/18 ILS OR LOC RWY 24L, Amdt
27A
26–Apr–18 .... CA Los Angeles ............ Los Angeles Intl ...................... 7/5981 3/1/18 RNAV (GPS) Y RWY 24L, Amdt
5
26–Apr–18 .... MN Alexandria ............... Chandler Field ......................... 7/9368 3/1/18 VOR RWY 22, Amdt 15
26–Apr–18 .... MN Alexandria ............... Chandler Field ......................... 8/0189 3/1/18 RNAV (GPS) RWY 22 , Orig
26–Apr–18 .... MS Batesville ................ Panola County ......................... 8/0713 2/20/18 RNAV (GPS) RWY 19, Amdt 1
26–Apr–18 .... IL Peoria ..................... General Downing—Peoria Intl 8/1895 3/1/18 ILS OR LOC RWY 13, Amdt 6F
26–Apr–18 .... CO Fort Collins/ Northern Colorado Rgnl .......... 8/2900 3/1/18 Takeoff Minimums and Obstacle
Loveland. DP, Amdt 5
26–Apr–18 .... TX Crosbyton ............... Crosbyton Muni ....................... 8/3493 3/1/18 Takeoff Minimums and Obstacle
DP, Orig
26–Apr–18 .... MI Lapeer ..................... Dupont-Lapeer ........................ 8/3495 3/1/18 Takeoff Minimums and Obstacle
DP, Amdt 3
26–Apr–18 .... TN Bristol/Johnson/ Tri-Cities .................................. 8/3742 2/20/18 RNAV (GPS) RWY 23, Amdt 1C
Kingsport.
26–Apr–18 .... OH Wooster .................. Wayne County ......................... 8/3745 3/1/18 Takeoff Minimums and Obstacle
DP, Amdt 1
26–Apr–18 .... KS Eureka .................... Lt William M Milliken ............... 8/3753 3/1/18 Takeoff Minimums and Obstacle
DP, Orig
26–Apr–18 .... MA New Bedford ........... New Bedford Rgnl ................... 8/3764 2/20/18 RNAV (GPS) RWY 14, Orig-B
26–Apr–18 .... ND Oakes ..................... Oakes Muni ............................. 8/3892 3/1/18 Takeoff Minimums and Obstacle
DP, Amdt 1
26–Apr–18 .... NV Reno ....................... Reno/Tahoe Intl ....................... 8/4030 2/20/18 ILS X OR LOC X RWY 16R,
Orig-A
26–Apr–18 .... NV Reno ....................... Reno/Tahoe Intl ....................... 8/4031 2/20/18 ILS Z OR LOC Z RWY 16R,
Orig-A
26–Apr–18 .... MA Vineyard Haven ...... Martha’s Vineyard ................... 8/5969 3/1/18 ILS OR LOC RWY 24, Amdt 3A
26–Apr–18 .... WA Pasco ...................... Tri-Cities .................................. 8/5970 3/1/18 ILS OR LOC/DME RWY 21R,
Amdt 13

[FR Doc. 2018–06009 Filed 3–28–18; 8:45 am] SUMMARY: The Food and Drug the development and issuance of
BILLING CODE 4910–13–P Administration (FDA or Agency) is guidance documents. The amendment
amending its good guidance practices provides an option for submitting the
regulation to inform the public on how draft of a proposed guidance to the
to electronically submit a draft of a Agency electronically through https://
DEPARTMENT OF HEALTH AND proposed guidance to the Agency. This www.regulations.gov at Docket No.
HUMAN SERVICES technical amendment is nonsubstantive. FDA–2013–S–0610.
DATES: This rule is effective March 29, Publication of this document
Food and Drug Administration 2018. constitutes final action on the change
FOR FURTHER INFORMATION CONTACT: under the Administrative Procedure Act
21 CFR Part 10 Megan Velez, Office of Policy, Food and (5 U.S.C. 553). This technical
Drug Administration, 10903 New amendment is nonsubstantive. FDA
[Docket No. FDA–2018–N–1097] Hampshire Ave., Bldg. 32, Rm. 4254, therefore, for good cause, has
Silver Spring, MD 20993–0002, 301– determined that notice and public
Good Guidance Practices; Technical
rmajette on DSKBCKNHB2PROD with RULES

796–9301. comment are unnecessary under 5
Amendment
SUPPLEMENTARY INFORMATION: FDA is U.S.C. 553(b)(3)(B). Further, this rule
AGENCY: Food and Drug Administration, amending 21 CFR 10.115(f)(3), good places no burden on affected parties for
HHS. guidance regulations, by adding which such parties would need a
language on how the public can reasonable time to prepare for the
Final rule; technical
ACTION:
electronically submit drafts of proposed effective date of the rule. Accordingly,
amendment.
guidance documents to participate in FDA, for good cause, has determined

VerDate Sep<11>2014 15:09 Mar 28, 2018 Jkt 244001 PO 00000 Frm 00041 Fmt 4700 Sfmt 4700 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 management requirements of the In addition, FEMA publishes a Flood
under 5 U.S.C. 553(d)(3) and that the program. If the Federal Emergency Insurance Rate Map (FIRM) that
rule can become effective upon Management Agency (FEMA) receives identifies the Special Flood Hazard
publication. documentation that the community has Areas (SFHAs) in these communities.
adopted the required floodplain The date of the FIRM, if one has been
List of Subjects in 21 CFR Part 10 management measures prior to the published, is indicated in the fourth
Administrative practice and effective suspension date given in this column of the table. No direct Federal
procedure, News media. rule, the suspension will not occur and financial assistance (except assistance
Therefore, under the Federal Food, a notice of this will be provided by pursuant to the Robert T. Stafford
Drug, and Cosmetic Act and under publication in the Federal Register on a Disaster Relief and Emergency
authority delegated to the Commissioner subsequent date. Also, information Assistance Act not in connection with a
of Food and Drugs, 21 CFR part 10 is identifying the current participation flood) may be provided for construction
amended as follows: status of a community can be obtained or acquisition of buildings in identified
from FEMA’s Community Status Book SFHAs for communities not
PART 10—ADMINISTRATIVE (CSB). The CSB is available at https:// participating in the NFIP and identified
PRACTICES AND PROCEDURES www.fema.gov/national-flood- for more than a year on FEMA’s initial
insurance-program-community-status- FIRM for the community as having
■ 1. The authority citation for part 10 book. flood-prone areas (section 202(a) of the
continues to read as follows: Flood Disaster Protection Act of 1973,
DATES: The effective date of each
Authority: 5 U.S.C. 551–558, 701–706; 15 community’s scheduled suspension is 42 U.S.C. 4106(a), as amended). This
U.S.C. 1451–1461; 21 U.S.C. 141–149, 321– the third date (‘‘Susp.’’) listed in the prohibition against certain types of
397, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 third column of the following tables. Federal assistance becomes effective for
U.S.C. 201, 262, 263b, 264. the communities listed on the date
FOR FURTHER INFORMATION CONTACT: If
■ 2. In § 10.115, add two sentences to you want to determine whether a shown in the last column. The
the end of paragraph (f)(3) to read as particular community was suspended Administrator finds that notice and
follows: on the suspension date or for further public comment procedures under 5
information, contact Adrienne L. U.S.C. 553(b), are impracticable and
§ 10.115 Good guidance practices. unnecessary because communities listed
Sheldon, PE, CFM, Federal Insurance
* * * * * and Mitigation Administration, Federal in this final rule have been adequately
(f) * * * Emergency Management Agency, 400 C notified.
(3) * * * If you wish to submit the Street SW, Washington, DC 20472, (202) Each community receives 6-month,
draft of a proposed guidance document 212–3966. 90-day, and 30-day notification letters
electronically, submit it through https:// addressed to the Chief Executive Officer
SUPPLEMENTARY INFORMATION: The NFIP
www.regulations.gov at Docket No. stating that the community will be
enables property owners to purchase
FDA–2013–S–0610. It is only necessary suspended unless the required
Federal flood insurance that is not
to submit one copy. floodplain management measures are
otherwise generally available from
* * * * * private insurers. In return, communities met prior to the effective suspension
Dated: March 20, 2018. agree to adopt and administer local date. Since these notifications were
Leslie Kux, floodplain management measures aimed made, this final rule may take effect
Associate Commissioner for Policy. at protecting lives and new construction within less than 30 days.
from future flooding. Section 1315 of National Environmental Policy Act.
[FR Doc. 2018–06252 Filed 3–28–18; 8:45 am]
the National Flood Insurance Act of FEMA has determined that the
BILLING CODE 4164–01–P
1968, as amended, 42 U.S.C. 4022, community suspension(s) included in
prohibits the sale of NFIP flood this rule is a non-discretionary action
insurance unless an appropriate public and therefore the National
DEPARTMENT OF HOMELAND body adopts adequate floodplain Environmental Policy Act of 1969 (42
SECURITY management measures with effective U.S.C. 4321 et seq.) does not apply.
Federal Emergency Management enforcement measures. The Regulatory Flexibility Act. The
Agency communities listed in this document no Administrator has determined that this
longer meet that statutory requirement rule is exempt from the requirements of
44 CFR Part 64 for compliance with program the Regulatory Flexibility Act because
regulations, 44 CFR part 59. the National Flood Insurance Act of
[Docket ID FEMA–2018–0002; Internal Accordingly, the communities will be 1968, as amended, Section 1315, 42
Agency Docket No. FEMA–8523] suspended on the effective date in the U.S.C. 4022, prohibits flood insurance
third column. As of that date, flood coverage unless an appropriate public
Suspension of Community Eligibility body adopts adequate floodplain
insurance will no longer be available in
AGENCY: Federal Emergency the community. We recognize that some management measures with effective
Management Agency, DHS. of these communities may adopt and enforcement measures. The
ACTION: Final rule. submit the required documentation of communities listed no longer comply
legally enforceable floodplain with the statutory requirements, and
SUMMARY: This rule identifies management measures after this rule is after the effective date, flood insurance
rmajette on DSKBCKNHB2PROD with RULES

communities where the sale of flood published but prior to the actual will no longer be available in the
insurance has been authorized under suspension date. These communities communities unless remedial action
the National Flood Insurance Program will not be suspended and will continue takes place.
(NFIP) that are scheduled for to be eligible for the sale of NFIP flood Regulatory Classification. This final
suspension on the effective dates listed insurance. A notice withdrawing the rule is not a significant regulatory action
within this rule because of suspension of such communities will be under the criteria of section 3(f) of
noncompliance with the floodplain published in the Federal Register. Executive Order 12866 of September 30,

VerDate Sep<11>2014 15:09 Mar 28, 2018 Jkt 244001 PO 00000 Frm 00042 Fmt 4700 Sfmt 4700 E:\FR\FM\29MRR1.SGM 29MRR1

Document Created: 2018-03-29 00:25:10
Document Modified: 2018-03-29 00:25:10

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule; technical amendment.
Dates		This rule is effective March 29, 2018.
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.
FR Citation		83 FR 13415
CFR Associated		Administrative Practice and Procedure and News Media

83 FR 13415 - Good Guidance Practices; Technical Amendment

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 61 (March 29, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration