82 FR 58815 - Public Workshop on Safety Assessment for Investigational New Drug Safety Reporting; Correction

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 239 (December 14, 2017)

Page Range		58815-58815
FR Document		2017-26938

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 The document announced a public workshop to engage external stakeholders in discussions related to finalizing the draft guidance entitled ``Safety Assessment for IND Safety Reporting.''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.

Federal Register, Volume 82 Issue 239 (Thursday, December 14, 2017)

[Federal Register Volume 82, Number 239 (Thursday, December 14, 2017)]
[Notices]
[Page 58815]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-26938]


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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.

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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external stakeholders in discussions related to finalizing the draft 
guidance entitled ``Safety Assessment for IND Safety Reporting.''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

Federal Register / Vol. 82, No. 239 / Thursday, December 14, 2017 / Notices 58815

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN (MEDICAL GASES) 1
Average
Number of
Number of Total annual burden per
21 CFR section/activity records per Total hours
recordkeepers records recordkeeping
recordkeeper (in hours) 1

SOP Maintenance ................................................................ 2,284 0.65 1,485 25 37,125
New startup SOPs ............................................................... 100 25 2,500 20 50,000
211.34—Consultants ............................................................ 2,284 0.25 571 0.5 286
211.67(c)—Equipment cleaning and maintenance .............. 2,284 32.5 74,230 0.25 18,558
211.68—Changes in master production and control
records or other records ................................................... 2,284 2 4,568 1 4,568
211.68(a)—Automatic, mechanical, and electronic equip-
ment .................................................................................. 2,284 10 22,840 0.5 11,420
211.68(b)—Computer or related systems ........................... 2,284 5 11,420 0.25 2,855
211.72—Filters ..................................................................... 2,284 0.25 571 1 571
211.80(d)—Components and drug product containers or
closures ............................................................................ 2,284 0.25 571 0.1 57
211.100(b)—Production and process controls .................... 2,284 3 6,382 2 13,704
211.105(b)—Equipment identification .................................. 2,284 0.25 571 0.25 143
211.122(c)—Labeling and packaging material .................... 2,284 50 114,200 0.25 28,550
211.130(e)—Labeling and packaging facilities .................... 2,284 50 114,200 0.25 28,550
211.132(c)—Tamper-evident packaging .............................. 2,284 20 45,680 0.5 22,840
211.132(d)—Tamper-evident packaging ............................. 2,284 0.2 457 0.5 229
211.137—Expiration dating .................................................. 2,284 3.25 7,423 0.33 2,450
211.160(a)—Laboratory controls ......................................... 2,284 2 4,568 1 4,568
211.165(e)—Test methodology ........................................... 2,284 1 2,284 1 2,284
211.166—Stability testing .................................................... 2,284 1.3 2,969 0.33 980
211.173—Laboratory animals .............................................. 2,284 1 2,284 0.25 571
211.180(e)—Production, control, and distribution records .. 2,284 0.2 457 0.25 114
211.180(f)—Procedures for notification of regulatory ac-
tions .................................................................................. 2,284 0.2 457 1 457
211.182—Equipment cleaning and use log ......................... 2,284 1.3 2,969 0.16 475
211.184—Component, drug product container, closure,
and labeling records ......................................................... 2,284 1.95 4,454 0.33 1,470
211.186—Master production and control records ............... 2,284 10 22,840 2 45,680
211.188—Batch production and control records ................. 2,284 16.25 37,115 1.3 48,250
211.192—Discrepancies in drug product production and
control records .................................................................. 2,284 2 4,568 1 4,568
211.194—Laboratory records .............................................. 2,284 25 57,100 0.5 28,550
211.196—Distribution records ............................................. 2,284 25 57,100 0.25 14,275
211.198—Complaint files ..................................................... 2,284 5 11,420 1 11,420
211.204—Returned drug products ...................................... 2,284 10 22,840 0.5 11,420

Total .............................................................................. ........................ ........................ ........................ ........................ 396,988
1 Burden 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. Investigational New Drug Safety held on January 11, 2018, from 9 a.m.
Leslie Kux, Reporting; Public Workshop’’ that to 4 p.m., Eastern Time.’’ is corrected to
Associate Commissioner for Policy. appeared in the Federal Register of read ‘‘The public workshop will be held
[FR Doc. 2017–26932 Filed 12–13–17; 8:45 am] November 27, 2017. The document on March 8, 2018, from 9 a.m. to 4 p.m.,
BILLING CODE 4164–01–P
announced a public workshop to engage Eastern Time.’’
external stakeholders in discussions
Dated: December 8, 2017.
related to finalizing the draft guidance
entitled ‘‘Safety Assessment for IND Leslie Kux,
DEPARTMENT OF HEALTH AND
HUMAN SERVICES Safety Reporting.’’ The date of the Associate Commissioner for Policy.
meeting has changed. [FR Doc. 2017–26938 Filed 12–13–17; 8:45 am]
Food and Drug Administration
FOR FURTHER INFORMATION CONTACT: BILLING CODE 4164–01–P

[Docket No. FDA–2015–D–4562] Lauren Wedlake, Center for Drug
Evaluation and Research, Food and
Public Workshop on Safety Drug Administration, 10903 New
Assessment for Investigational New Hampshire Ave., Bldg. 51, Rm. 6362,
Drug Safety Reporting; Correction Silver Spring, MD 20993, 301–796–
sradovich on DSK3GMQ082PROD with NOTICES

AGENCY: Food and Drug Administration, 2728, Lauren.Wedlake@fda.hhs.gov.
HHS. In the Federal Register of Monday,
ACTION: Notice; correction. November 27, 2017, in FR Doc. 2017–
25454, the following correction is made:
SUMMARY: The Food and Drug 1. On page 56036, in the first column,
Administration is correcting a notice in the first sentence of the DATES
entitled ‘‘Safety Assessment for section, ‘‘The public workshop will be

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Document Created: 2018-10-25 10:52:45
Document Modified: 2018-10-25 10:52:45

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		Notices
Action		Notice; correction.
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]
FR Citation		82 FR 58815

82 FR 58815 - Public Workshop on Safety Assessment for Investigational New Drug Safety Reporting; Correction

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 239 (December 14, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration