Administrative Actions for Noncompliance; Lesser Administrative Actions; Confirmation of Effective Date, 47288 [2016-17186]

Download as PDF 47288 Federal Register / Vol. 81, No. 140 / Thursday, July 21, 2016 / Rules and Regulations Food and Drug Administration 21 CFR Part 56 [Docket No. FDA–2015–N–5052] Administrative Actions for Noncompliance; Lesser Administrative Actions; Confirmation of Effective Date AGENCY: Food and Drug Administration, HHS. Direct final rule; confirmation of effective date. ACTION: The Food and Drug Administration (FDA) is confirming the effective date of August 17, 2016, for the direct final rule that appeared in the Federal Register of April 4, 2016. The direct final rule amends the regulations describing lesser administrative actions that may be imposed on an Institutional Review Board (IRB) that has failed to comply with applicable regulations. We are taking this action to ensure clarity and improve the accuracy of the regulations. This document confirms the effective date of the direct final rule. DATES: Effective date of final rule published in the Federal Register of April 4, 2016 (81 FR 19033), confirmed: August 17, 2016. FOR FURTHER INFORMATION CONTACT: Sheila Brown, Office of Good Clinical Practice, Office of Special Medical Programs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993–0002, 301–796–6563. SUMMARY: In the Federal Register of April 4, 2016 (81 FR 19033), FDA solicited comments concerning the direct final rule for a 75day period ending June 20, 2016. FDA stated that the effective date of the direct final rule would be on August 17, 2016, no later than 60 days after the end of the comment period, unless any significant adverse comment was submitted to FDA during the comment period. FDA did not receive any significant adverse comments. SUPPLEMENTARY INFORMATION: DEPARTMENT OF HEALTH AND HUMAN SERVICES Authority: 21 U.S.C. 321, 343, 346, 346a, 348, 350a, 350b, 351, 352, 353, 355, 360, 360c–360f, 360h, 360i, 360j, 360hh–360ss, 371, 379e, 381; 42 U.S.C. 216, 241, 262. Accordingly, the amendment issued thereby is effective. Dated: July 15, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–17186 Filed 7–20–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF THE INTERIOR Bureau of Indian Affairs 25 CFR Part 23 [K00103 12/13 A3A10; 134D0102DR– DS5A300000–DR.5A311.IA000113] RIN 1076–AF25 Indian Child Welfare Act Proceedings Bureau of Indian Affairs, Interior. ACTION: Announcement of training sessions. AGENCY: The Department of the Interior (Department) is hosting training SUMMARY: Time Monday, August 15, 2016 ......... 2:00 p.m.–4:00 p.m. (ET) ......... Webinar Tuesday, August 16, 2016 ........ 2:00 p.m.–4:00 p.m. (ET) ......... Webinar Thursday, August 18, 2016 ....... 8:30 a.m.–4:00 Time). 8:30 a.m.–4:00 Time). p.m. (Local On-Site ... p.m. (Local On-Site ... 8:30 a.m.–4:00 Time). 8:30 a.m.–4:00 Time). 8:30 a.m.–4:00 Time). 8:30 a.m.–4:00 Time). 8:30 a.m.–4:00 Time). p.m. (Local On-Site ... p.m. (Local On-Site ... p.m. (Local On-Site ... p.m. (Local On-Site ... p.m. (Local On-Site ... 9:30 a.m.–5:00 p.m. (Local Time). 2:00 p.m.–4:00 p.m. (ET) ......... On-Site ... Wednesday, September 7, 2016 Thursday, September 15, 2016 Thursday, September 22, 2016 Lhorne on DSK30JT082PROD with RULES Wednesday, October 5, 2016 .... Wednesday, October 19, 2016 .. Wednesday, November 2, 2016 Tuesday, November 15, 2016 ... VerDate Sep<11>2014 14:56 Jul 20, 2016 Jkt 238001 PO 00000 DATES: See the SUPPLEMENTARY INFORMATION section of this document for dates of the training sessions. ADDRESSES: See the SUPPLEMENTARY INFORMATION section of this document for addresses of the training sessions. Ms. Debra Burton, ICWA Specialist, Office of Indian Services, Bureau of Indian Affairs, (202) 513–7610, debra.burton@ bia.gov, or Ms. Elizabeth Appel, Office of Regulatory Affairs & Collaborative Action—Indian Affairs, (202) 273–4680; elizabeth.appel@bia.gov. FOR FURTHER INFORMATION CONTACT: On June 14, 2016, the Department published a final rule on Indian Child Welfare Act proceedings, in implementation of ICWA. See 81 FR 38778. To help those affected by the final rule—in particular States courts, State agencies, Tribes, private agencies—to prepare for the December 12, 2016, effective date of the final rule, the Department is offering several training sessions on the final rule. The following chart shows the current schedule for training sessions. Please check the following Web site for updates: http://www.bia.gov/ WhoWeAre/BIA/OIS/HumanServices/ index.htm. This Web site also includes the training materials and the full text of the regulation. SUPPLEMENTARY INFORMATION: Date Wednesday, August 24, 2016 ... sessions on its regulations implementing the Indian Child Welfare Act (ICWA) for federally recognized Indian Tribes and for State court and child welfare agency personnel. This document announces the dates and locations of the training sessions. Type Frm 00004 Webinar Fmt 4700 Sfmt 4700 Location Please see Web site listed above for call-in and log-in information. Please see Web site listed above for call-in and log-in information. St. Paul, Minnesota—Doubletree St. Paul, 411 Minnesota Street, St. Paul, MN 55101. Oklahoma City, OK—Supreme Court of Oklahoma, Judicial Center Auditorium, 2100 North Lincoln, Suite 3, Oklahoma City, OK 73105. Sacramento, CA—Secretary of State Auditorium, 1500 11th Street, Sacramento, CA 95814. Albany, NY—Empire State Plaza Convention Center, Meeting Rooms 2 & 3, Albany, NY 12242. Pierre, SD—Best Western Ramkota Hotel & Convention Center, Amphitheater II, 920 West Sioux Ave., Pierre, SD 57501. Anchorage, AK—Embassy Suites Hilton, Imagine Ballroom, 600 E. Benson Blvd., Anchorage, AK 99503. Olympia, WA—Legislative Building on the Capitol Campus, Columbia Room, Sid Snyder and Cherry Lane SW., Olympia, WA 98504–1034. Phoenix, AZ—Burton Barr Central Library, The Pulliam Auditorium, 1221 N. Central Avenue, Phoenix, AZ 85004. Please see Web site listed above for call-in and log-in information. E:\FR\FM\21JYR1.SGM 21JYR1

Agencies

[Federal Register Volume 81, Number 140 (Thursday, July 21, 2016)]
[Rules and Regulations]
[Page 47288]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17186]



[[Page 47288]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 56

[Docket No. FDA-2015-N-5052]


Administrative Actions for Noncompliance; Lesser Administrative 
Actions; Confirmation of Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule; confirmation of effective date.

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SUMMARY: The Food and Drug Administration (FDA) is confirming the 
effective date of August 17, 2016, for the direct final rule that 
appeared in the Federal Register of April 4, 2016. The direct final 
rule amends the regulations describing lesser administrative actions 
that may be imposed on an Institutional Review Board (IRB) that has 
failed to comply with applicable regulations. We are taking this action 
to ensure clarity and improve the accuracy of the regulations. This 
document confirms the effective date of the direct final rule.

DATES: Effective date of final rule published in the Federal Register 
of April 4, 2016 (81 FR 19033), confirmed: August 17, 2016.

FOR FURTHER INFORMATION CONTACT: Sheila Brown, Office of Good Clinical 
Practice, Office of Special Medical Programs, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver 
Spring, MD 20993-0002, 301-796-6563.

SUPPLEMENTARY INFORMATION: In the Federal Register of April 4, 2016 (81 
FR 19033), FDA solicited comments concerning the direct final rule for 
a 75-day period ending June 20, 2016. FDA stated that the effective 
date of the direct final rule would be on August 17, 2016, no later 
than 60 days after the end of the comment period, unless any 
significant adverse comment was submitted to FDA during the comment 
period. FDA did not receive any significant adverse comments.

    Authority: 21 U.S.C. 321, 343, 346, 346a, 348, 350a, 350b, 351, 
352, 353, 355, 360, 360c-360f, 360h, 360i, 360j, 360hh-360ss, 371, 
379e, 381; 42 U.S.C. 216, 241, 262. Accordingly, the amendment 
issued thereby is effective.

    Dated: July 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-17186 Filed 7-20-16; 8:45 am]
BILLING CODE 4164-01-P