Federal Register / Vol. 85, No. 231 / Tuesday, December 1, 2020 / Notices 77219 

Finally, the National Adult Protective 

Services Association (NAPSA) 

conducted a survey of State APS 

programs in 2012, and the National 

Association of State Units on Aging and 

Disability (NASUAD) fielded a survey to 

its members, which are not APS 

programs, in January 2018 intended to 

update findings from the NAPSA 2012 

survey. Since the survey replicates the 

original NAPSA survey, the questions in 

it are not focused on APS practice and 

are not directed at the same respondents 

as the proposed survey. As noted, a few 

topics in the original survey overlap 

with the proposed instrument, but the 

wording and focus of the few questions 

on similar topics are different. From this 

analysis, we conclude the proposed APS 

Practice Survey will yield vital 

information on APS practice not 

available from other sources. 

Proposed Collection Efforts 

The APS Practice Survey will collect 

state- and territory-specific practices for 

all aspects of APS casework practice, 

including staffing, intake, investigation, 

service planning and delivery, and 

quality assurance. Across these areas, 

the survey will collect information on 

practices such as community 

partnerships and use of assessment 

tools. 

The APS Practice Survey will be 

administered online using 

SurveyMonkey or a similar commercial 

survey-programming tool. The online 

survey will include data validation 

routines to minimize errors or 

unintentional omissions and will 

include appropriate skip patterns to 

reduce burden. Respondents will be 

state and territory APS agencies, 

including APS agencies in the District of 

Columbia, Puerto Rico, Guam, Northern 

Marianas Islands, Virgin Islands, and 

American Samoa. No personally 

identifiable information will be 

collected. 

A pilot version of The APS Practice 

Survey was tested in nine (9) diverse 

states between July and September 

2017. Following their pretest of the 

survey instrument, pilot respondents 

participated in focus groups in which 

they provided recommendations on data 

collection procedures, views on the 

availability of data being requested, and 

estimates of the burden to each state and 

territory for completion of the survey. It 

is assumed that nearly every state and 

territory will participate and that time to 

develop a response will be similar to the 

experience of states during the pilot test. 

ACL has calculated the following 

burden estimates based on the results of 

the survey pilot test. 

To review and comment on the 

proposed data collection, please visit 

the ACL public input site at https://

www.acl.gov/about-acl/public-input. 

Estimated Program Burden 

ACL estimates the annual burden 

associated with this collection of 

information as follows: 

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total burden 

hours 

APS Practice Survey ....................................................................................... 56 1 3.50 196 

Estimated Total Annual Burden 

Hours: 196. 

Dated: November 25, 2020. 

Lance Robertson, 

Administrator and Assistant Secretary for 

Aging. 

[FR Doc. 2020–26514 Filed 11–30–20; 8:45 am] 

BILLING CODE 4154–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–1671] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Good Laboratory 

Practice for Nonclinical Laboratory 

Studies 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by December 

31, 2020. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0119. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Good Laboratory Practice for 

Nonclinical Laboratory Studies—21 

CFR Part 58 

OMB Control Number 0910–0119— 

Extension 

Sections 409, 505, 512, and 515 of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 348, 355, 360b, and 360e) and 

related statutes require manufacturers of 

food additives, human drugs and 

biological products, animal drugs, and 

medical devices to demonstrate the 

safety and utility of their product by 

submitting applications to FDA for 

research or marketing permits. Such 

applications contain, among other 

important items, full reports of all 

studies done to demonstrate product 

safety in man and/or other animals. In 

order to ensure adequate quality control 

for these studies and to provide an 

adequate degree of consumer protection, 

the Agency issued good laboratory 

practice (GLP) regulations for 

nonclinical laboratory studies in part 58 

(21 CFR part 58). The regulations 

specify minimum standards for the 

proper conduct of safety testing and 

contain sections on facilities, personnel, 

equipment, standard operating 

procedures (SOPs), test and control 

articles, quality assurance, protocol and 

conduct of a safety study, records and 

reports, and laboratory disqualification, 


khammond on DSKJM1Z7X2PROD with NOTICES4
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 


khammond on DSKJM1Z7X2PROD with NOTICES4