82906 Federal Register / Vol. 88, No. 226 / Monday, November 27, 2023 / Notices 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden per 

response Total hours 

Focus groups ........................................................... 3,000 1 3,000 1.75 ........................... 5,250 

Customer comment cards/forms .............................. 1,500 1 1,500 0.25 (15 minutes) ...... 375 

Small discussion groups .......................................... 800 1 800 1.75 ........................... 1,400 

Customer satisfaction surveys ................................. 20,000 1 20,000 0.33 (20 minutes) ...... 6,600 

Usability studies ....................................................... 1,100 1 1,100 1 ................................ 1,100 

Total .................................................................. ........................ ........................ ........................ .................................... 14,725 

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, we increased the 

number of respondents for focus groups, 

customer comment cards/forms, 

customer satisfaction surveys, and 

usability studies. This adjustment 

results in an overall burden increase of 

6,234 hours. 

Dated: November 21, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–26043 Filed 11–24–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–2894] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Good Laboratory 

Practice Requirements for Nonclinical 

Laboratory Studies 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, we, or the 

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 

27, 2023. 

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 

Requirements 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, 

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. 

Description of Respondents: 

Respondents to the collection of 

information are sponsors of nonclinical 

laboratory studies that support or are 

intended to support applications for 

research or marketing permits for 

products regulated by FDA. 

In the Federal Register of August 8, 

2023 (88 FR 53492), we published a 60- 

day notice soliciting comment on the 

proposed collection of information. One 

comment was received underscoring the 

critical nature of language translations 

in information exchange between 

international communities but did not 

suggest any modifications to our burden 

estimates. 

We estimate the burden of this 

collection of information as follows: 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 88, No. 226 / Monday, November 27, 2023 / Notices 82907 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section 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 BURDEN1

21 CFR section 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 an evaluation of the 

information collection, we are retaining 

the currently approved estimates. Our 

assumptions made regarding the time 

needed for the respective activities is 

based on our experience with the 

information collection and informal 

communications with respondents. 

Dated: November 21, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–26044 Filed 11–24–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Notice of Declaration Under the Public 

Readiness and Emergency 

Preparedness Act for 

Countermeasures Against Ebolavirus 

and/or Ebola Disease and 

Marburgvirus and/or Marburg Disease 

ACTION: Notice of amendment. 

SUMMARY: The Secretary issues this 

amendment pursuant to section 319F–3 

of the Public Health Service Act to 

amend the Declaration for 

Countermeasures against Marburgvirus 

and/or Marburg Disease to cover both 

Ebolaviruses and Marburgviruses and 

republishes the declaration, as 

amended. The amended republished 

Declaration clarifies that the disease 

threat includes Ebolaviruses and 

Marburgviruses, updates the title of the 

Declaration, expands the Covered 

Countermeasures, and extends the 

effective time period. 

DATES: The amendment is effective as of 

January 1, 2024. 

FOR FURTHER INFORMATION CONTACT: L. 

Paige Ezernack, Office of the Assistant 

Secretary for Preparedness and 

Response, Office of the Secretary, U.S. 

Department of Health and Human 

Services, 200 Independence Avenue 

SW, Washington, DC 20201; 202–260– 

0365, PREPAct@hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Public Readiness and Emergency 

Preparedness Act (PREP Act) authorizes 

the Secretary of the U.S. Department of 

Health and Human Services (the HHS 

Secretary) to issue a Declaration to 

provide liability immunity to certain 

individuals and entities (Covered 

Persons) against any claim of loss 

caused by, arising out of, relating to, or 

resulting from the manufacture, 

distribution, administration, or use of 

medical countermeasures (Covered 

Countermeasures), except for claims 

involving ‘‘willful misconduct’’ as 

defined in the PREP Act. Under the 

PREP Act, a Declaration may be 

amended as circumstances warrant. 

The PREP Act was enacted on 

December 30, 2005, as Public Law 109– 

148, Division C, 2. It amended the 

Public Health Service (PHS) Act, adding 

section 319F–3, which addresses 

liability immunity, and section 319F–4, 

which creates a compensation program. 

These sections are codified at 42 U.S.C. 

247d–6d and 42 U.S.C. 247d–6e, 

respectively. Section 319F–3 of the PHS 

Act has been amended by the Pandemic 

and All-Hazards Preparedness 

Reauthorization Act (PAHPRA), Public 

Law 113–5, enacted on March 13, 2013, 

and the Coronavirus Aid, Relief, and 

Economic Security (CARES) Act, Public 

Law 116–136, enacted on March 27, 

2020, to expand Covered 

Countermeasures under the PREP Act. 

The PREP Act Declaration for 

Countermeasures Against Marburgvirus 

and/or Marburg Disease was first issued 

effective November 25, 2020. (85 FR 

79198 (December 9, 2020)). The PREP 

Act Declaration for Ebola Virus Disease 

Vaccines was first issued December 3, 

2014 (79 FR 73315 (Dec.10, 2014)), and 

amended December 3, 2015 (80 FR 

76541 (Dec. 9, 2015)), December 3, 2016 

(81 FR 89471 (Dec. 12, 2016)), and 

December 1, 2018 (84 FR 764 (Jan. 31, 

2019)). The Declaration for Ebola Virus 


khammond on DSKJM1Z7X2PROD with NOTICES