Public Workshop on Safety Assessment for Investigational New Drug Safety Reporting; Correction, 58815 [2017-26938]

Download as PDF 58815 Federal Register / Vol. 82, No. 239 / Thursday, December 14, 2017 / Notices TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN (MEDICAL GASES) 1 Number of recordkeepers 21 CFR section/activity SOP Maintenance ................................................................ New startup SOPs ............................................................... 211.34—Consultants ............................................................ 211.67(c)—Equipment cleaning and maintenance .............. 211.68—Changes in master production and control records or other records ................................................... 211.68(a)—Automatic, mechanical, and electronic equipment .................................................................................. 211.68(b)—Computer or related systems ........................... 211.72—Filters ..................................................................... 211.80(d)—Components and drug product containers or closures ............................................................................ 211.100(b)—Production and process controls .................... 211.105(b)—Equipment identification .................................. 211.122(c)—Labeling and packaging material .................... 211.130(e)—Labeling and packaging facilities .................... 211.132(c)—Tamper-evident packaging .............................. 211.132(d)—Tamper-evident packaging ............................. 211.137—Expiration dating .................................................. 211.160(a)—Laboratory controls ......................................... 211.165(e)—Test methodology ........................................... 211.166—Stability testing .................................................... 211.173—Laboratory animals .............................................. 211.180(e)—Production, control, and distribution records .. 211.180(f)—Procedures for notification of regulatory actions .................................................................................. 211.182—Equipment cleaning and use log ......................... 211.184—Component, drug product container, closure, and labeling records ......................................................... 211.186—Master production and control records ............... 211.188—Batch production and control records ................. 211.192—Discrepancies in drug product production and control records .................................................................. 211.194—Laboratory records .............................................. 211.196—Distribution records ............................................. 211.198—Complaint files ..................................................... 211.204—Returned drug products ...................................... Total .............................................................................. 1 Burden BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Total hours 0.65 25 0.25 32.5 1,485 2,500 571 74,230 25 20 0.5 0.25 37,125 50,000 286 18,558 2,284 2 4,568 1 4,568 2,284 2,284 2,284 10 5 0.25 22,840 11,420 571 0.5 0.25 1 11,420 2,855 571 2,284 2,284 2,284 2,284 2,284 2,284 2,284 2,284 2,284 2,284 2,284 2,284 2,284 0.25 3 0.25 50 50 20 0.2 3.25 2 1 1.3 1 0.2 571 6,382 571 114,200 114,200 45,680 457 7,423 4,568 2,284 2,969 2,284 457 0.1 2 0.25 0.25 0.25 0.5 0.5 0.33 1 1 0.33 0.25 0.25 57 13,704 143 28,550 28,550 22,840 229 2,450 4,568 2,284 980 571 114 2,284 2,284 0.2 1.3 457 2,969 1 0.16 457 475 2,284 2,284 2,284 1.95 10 16.25 4,454 22,840 37,115 0.33 2 1.3 1,470 45,680 48,250 2,284 2,284 2,284 2,284 2,284 2 25 25 5 10 4,568 57,100 57,100 11,420 22,840 1 0.5 0.25 1 0.5 4,568 28,550 14,275 11,420 11,420 ........................ ........................ ........................ ........................ 396,988 FOR FURTHER INFORMATION CONTACT: [Docket No. FDA–2015–D–4562] sradovich on DSK3GMQ082PROD with NOTICES Average burden per recordkeeping (in hours) 1 2,284 100 2,284 2,284 Investigational New Drug Safety Reporting; Public Workshop’’ that appeared in the Federal Register of November 27, 2017. The document announced a public workshop to engage external stakeholders in discussions related to finalizing the draft guidance entitled ‘‘Safety Assessment for IND Safety Reporting.’’ The date of the meeting has changed. [FR Doc. 2017–26932 Filed 12–13–17; 8:45 am] Public Workshop on Safety Assessment for Investigational New Drug Safety Reporting; Correction Food and Drug Administration, HHS. ACTION: Total annual records estimates of less than 1 hour are expressed as a fraction of an hour in the format ‘‘[number of minutes per response]/60’’. Dated: December 8, 2017. Leslie Kux, Associate Commissioner for Policy. AGENCY: Number of records per recordkeeper Notice; correction. The Food and Drug Administration is correcting a notice entitled ‘‘Safety Assessment for SUMMARY: VerDate Sep<11>2014 21:28 Dec 13, 2017 Jkt 244001 held on January 11, 2018, from 9 a.m. to 4 p.m., Eastern Time.’’ is corrected to read ‘‘The public workshop will be held on March 8, 2018, from 9 a.m. to 4 p.m., Eastern Time.’’ Dated: December 8, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–26938 Filed 12–13–17; 8:45 am] BILLING CODE 4164–01–P Lauren Wedlake, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6362, Silver Spring, MD 20993, 301–796– 2728, Lauren.Wedlake@fda.hhs.gov. In the Federal Register of Monday, November 27, 2017, in FR Doc. 2017– 25454, the following correction is made: 1. On page 56036, in the first column, in the first sentence of the DATES section, ‘‘The public workshop will be PO 00000 Frm 00024 Fmt 4703 Sfmt 9990 E:\FR\FM\14DEN1.SGM 14DEN1

Agencies

[Federal Register Volume 82, Number 239 (Thursday, December 14, 2017)]
[Notices]
[Page 58815]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26938]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-4562]


Public Workshop on Safety Assessment for Investigational New Drug 
Safety Reporting; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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

SUMMARY: The Food and Drug Administration is correcting a notice 
entitled ``Safety Assessment for Investigational New Drug Safety 
Reporting; Public Workshop'' that appeared in the Federal Register of 
November 27, 2017. The document announced a public workshop to engage 
external stakeholders in discussions related to finalizing the draft 
guidance entitled ``Safety Assessment for IND Safety Reporting.'' The 
date of the meeting has changed.

FOR FURTHER INFORMATION CONTACT: Lauren Wedlake, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6362, Silver Spring, MD 20993, 301-796-
2728, [email protected].
    In the Federal Register of Monday, November 27, 2017, in FR Doc. 
2017-25454, the following correction is made:
    1. On page 56036, in the first column, in the first sentence of the 
DATES section, ``The public workshop will be held on January 11, 2018, 
from 9 a.m. to 4 p.m., Eastern Time.'' is corrected to read ``The 
public workshop will be held on March 8, 2018, from 9 a.m. to 4 p.m., 
Eastern Time.''

    Dated: December 8, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26938 Filed 12-13-17; 8:45 am]
BILLING CODE 4164-01-P