77220 Federal Register / Vol. 85, No. 231 / Tuesday, December 1, 2020 / Notices 

and include information collection 

provisions. 

Part 58 requires testing facilities 

engaged in conducting toxicological 

studies to retain, and make available to 

regulatory officials, records regarding 

compliance with GLPs. Records are 

maintained on file at each testing 

facility and examined there periodically 

by FDA inspectors. The GLP regulations 

require that, for each nonclinical 

laboratory study, a final report be 

prepared that documents the results of 

quality assurance unit inspections, test 

and control article characterization, 

testing of mixtures of test and control 

articles with carriers, and an overall 

interpretation of nonclinical laboratory 

studies. The GLP regulations also 

require written records pertaining to: (1) 

Personnel job descriptions and 

summaries of training and experience; 

(2) master schedules, protocols and 

amendments thereto, inspection reports, 

and SOPs; (3) equipment inspection, 

maintenance, calibration, and testing 

records; (4) documentation of feed and 

water analyses and animal treatments; 

(5) test article accountability records; 

and (6) study documentation and raw 

data. 

In the Federal Register of July 24, 

2020 (85 FR 44900), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. 

One comment was received that 

encouraged implementation of 

automated collection methods and 

analytical software to evaluate results. 

FDA appreciates this comment and 

continually seek ways to employ 

efficient collection methods using our 

limited resources. The comment 

suggested no revision to our burden 

estimate. 

FDA estimates the burden of this 

information collection as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR part Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

58.35(b)(7); Quality assurance unit ................................ 300 60.25 18,075 1 18,075 

58.185; Reporting of nonclinical laboratory study results 300 60.25 18,075 27.65 499,774 

Total ......................................................................... ........................ .......................... ........................ ........................... 517,849 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR part Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

58.29(b); Personnel .......................................................... 300 20 6,000 .21 (13 minutes) 1,260 

58.35(b)(1)–(6) and (c); Quality assurance unit ............... 300 270.76 81,228 3.36 .................. 272,926 

58.63(b) and (c); Maintenance and calibration of equipment.300 60 18,000 .09 (5 minutes) 1,620 

58.81(a)–(c); SOPs ........................................................... 300 301.80 90,540 .14 (8 minutes) 12,676 

58.90(c) and (g); Animal care ........................................... 300 62.70 18,810 .13 (8 minutes) 2,445 

58.105(a) and (b); Test and control article characterization.300 5 1,500 11.8 .................. 17,700 

58.107(d); Test and control article handling ..................... 300 1 300 4.25 .................. 1,275 

58.113(a); Mixtures of articles with carriers ..................... 300 15.33 4,599 6.8 .................... 31,273 

58.120; Protocol ................................................................ 300 15.38 4,614 32.7 .................. 150,878 

58.195; Retention of records ............................................ 300 251.50 75,450 3.9 .................... 294,255 

Total ........................................................................... ........................ ........................ ........................ ........................... 786,308 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Based on a review of the information 

collection since our last request for 

OMB approval, FDA has made no 

adjustments to our burden estimate. 

Dated: November 24, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–26502 Filed 11–30–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–N–1845] 

Fixed-Quantity Unit-of-Use Blister 

Packaging for Certain ImmediateRelease Opioid Analgesics for 

Treatment of Acute Pain; 

Establishment of a Public Docket; 

Request for Comments; Reopening of 

the Comment Period and Provision of 

Additional Information and Analysis 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; reopening of the 

comment period. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

reopening the comment period for and 

providing additional information and 

analysis regarding the notice entitled 

‘‘Fixed-Quantity Unit-of-Use Blister 

Packaging for Certain ImmediateRelease Opioid Analgesics for 

Treatment of Acute Pain; Establishment 

of a Public Docket; Request for 

Comments’’ that appeared in the 

Federal Register of May 31, 2019. The 

Agency is taking this action to provide 

additional information and to allow 


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Federal Register / Vol. 85, No. 231 / Tuesday, December 1, 2020 / Notices 77221 

interested persons additional time to 

submit comments. 

DATES: FDA is reopening the comment 

period for the notice published on May 

31, 2019 (84 FR 25283). Submit either 

electronic or written comments on the 

notice by February 1, 2021. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before February 1, 

2021. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of February 1, 2021. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2019–N–1845 for ‘‘Fixed-Quantity Unitof-Use Blister Packaging for Certain 

Immediate-Release Opioid Analgesics 

for Treatment of Acute Pain.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), will be placed 

in the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Patrick Raulerson, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6260, 

Silver Spring, MD 20993, 301–796– 

3522, Patrick.Raulerson@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of May 31, 2019 (84 FR 

25283), FDA published a notice entitled 

‘‘Fixed-Quantity Unit-of-Use Blister 

Packaging for Certain ImmediateRelease Opioid Analgesics for 

Treatment of Acute Pain; Establishment 

of a Public Docket; Request for 

Comments’’ with a 60-day comment 

period. The notice described a potential 

modification to the Opioid Analgesic 

Risk Evaluation and Mitigation Strategy 

(REMS) to require that certain solid, oral 

dosage forms of immediate-release 

opioid analgesics commonly prescribed 

for treatment of acute pain be made 

available in fixed-quantity unit-of-use 

blister packaging for outpatient 

dispensing. The intent would be to 

reduce the amount of unused opioid 

analgesics, thereby reducing 

opportunities for misuse, abuse, 

inappropriate access, and overdose, and 

possibly reducing the development of 

new opioid addiction. Prescribers 

would continue to exercise their clinical 

judgement to prescribe opioid 

analgesics in the quantity appropriate 

for a given patient. That is, the blister 

packaging configurations under 

consideration would not be required to 

be the only packaging option available 

for these products. 

Following an initial review of 

comments received, FDA held a series 

of listening sessions with stakeholders, 

which included an FDA slide 

presentation containing additional 

information and analysis regarding this 

potential REMS modification. FDA is 

now reopening the comment period to 

obtain additional written comments 

from stakeholders and to add to the 

docket this slide presentation. The 

comment period will be open until 

February 1, 2021. The Agency believes 

that an additional 60 days will allow 

adequate time for interested persons to 

submit comments. 

Dated: November 24, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–26504 Filed 11–30–20; 8:45 am] 

BILLING CODE 4164–01–P 


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