Federal Register / Vol. 89, No. 8 / Thursday, January 11, 2024 / Notices 1921 

nationally representative survey data to 

learn more about where parents look for 

and find information about Child Care 

and Early Education (CCEE); how 

parents assess the people, places, or 

things that may offer CCEE information; 

what types of CCEE information parents 

look for; and how parents use 

information to make CCEE selections. 

The study aims to gather information 

that may be used by Child Care Lead 

Agencies to inform their consumer 

education efforts. 

DATES: Comments due within 30 days of 

publication. OMB must make a decision 

about the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. You can also obtain 

copies of the proposed collection of 

information by emailing 

OPREinfocollection@acf.hhs.gov. 

Identify all requests by the title of the 

information collection. 

SUPPLEMENTARY INFORMATION: 

Description: ACF has contracted with 

NORC to implement this study, which 

is part of the Consumer Education and 

Parental Choice in Early Care and 

Education (CEPC) project. The study 

will select a nationally representative 

sample from NORC’s probability-based 

AmeriSpeak panel. The AmeriSpeak 

panel provides sample coverage of 

approximately 97 percent of the U.S. 

population. It currently contains 48,900 

panel members age 13 and over residing 

in over 40,000 households. U.S. 

households are randomly selected with 

a known, non-zero probability from the 

NORC National Frame, and then 

recruited by mail, telephone, and by 

field interviewers face-to-face. NORC’s 

in-person recruitment enhances 

representativeness for young adults, 

lower socio-economic households, noninternet households, and other 

households that are typically hard to 

reach for statistical surveys of the 

population. 

We will collect information about (a) 

where parents look for and find 

information about CCEE; (b) how 

parents assess the people, places, or 

things that may offer CCEE information; 

(c) how easy or hard it is for parents to 

find CCEE information, (d) the types of 

CCEE information that parents look for 

and say are helpful in choosing CCEE; 

(e) information about the last time 

parents made a decision about CCEE 

and what information they tried to learn 

about at that time; (f) parent’s 

assessments of the CCEE options at the 

time they made their last CCEE 

decision; (g) how well parents’ CCEE 

decision met their family’s needs; and 

(h) demographic information about 

families. 

Respondents: AmeriSpeak panelists 

who indicated that they have a young 

child in the household will be invited 

to complete the survey if they are at 

least 18 years of age. If a household has 

two or more panel members who reside 

in a household with a young child, one 

will be selected at random to complete 

the survey, with preference given to 

parents/legal guardians. Selected 

panelists will be asked questions to 

confirm eligibility for the survey, 

including that the household has at least 

one child under the age of 6 but not in 

kindergarten. 

Annual Burden Estimates: 

Instrument 

Number of 

respondents 

(total over 

request 

period) 

Number of 

responses per 

respondent 

(total over 

request 

period) 

Average 

burden per 

response 

(in hours) 

Total/annual 

burden 

(in hours) 

Parent Survey Questionnaire (Section AE Only) ............................................ 2,100 1 .08 168 

Parent Survey Questionnaire (Section A–DA) ................................................ 1,500 1 .25 375 

Estimated Total Annual Burden 

Hours: 543. 

Authority: Child Care and 

Development Block Grant (CCDBG) Act 

of 1990, as amended (42 U.S.C. 9857 et 

seq.). 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2024–00395 Filed 1–10–24; 8:45 am] 

BILLING CODE 4184–23–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–3743] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Electronic 

Records; Electronic Signatures 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) 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 February 

12, 2024. 

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 0910–0303. 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 


ddrumheller on DSK120RN23PROD with NOTICES1
1922 Federal Register / Vol. 89, No. 8 / Thursday, January 11, 2024 / Notices 

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. 

Electronic Records; Electronic 

Signatures—21 CFR Part 11 

OMB Control Number 0910–0303— 

Revision 

This information collection supports 

implementation of statutory and 

regulatory authorities that govern 

criteria for the acceptance of electronic 

records, electronic signatures, and 

handwritten signatures executed to 

electronic records as equivalent to paper 

records. Agency regulations in part 11 

(21 CFR part 11) provide for the 

submission of records and reports and 

establish that information may be 

submitted to FDA electronically 

provided that we have stated our ability 

to accept the records electronically in an 

Agency-established public docket and 

that the other requirements of part 11 

are met. The regulations apply to 

records in electronic form that are 

created, modified, maintained, archived, 

retrieved, or transmitted, under any 

records requirements set forth in 

Agency regulations and to electronic 

records submitted under requirements 

of the Federal Food, Drug, and Cosmetic 

Act and the Public Health Service Act, 

even if such records are not specifically 

identified in Agency regulations. 

Regulations in part 11, subpart B 

(§§ 11.10 through 11.70) require the 

establishment of standard operating 

procedures to ensure appropriate use of 

and precautions for systems using 

electronic records and signatures, 

including the following: (1) § 11.10 

specifies procedures and controls for 

persons who use closed systems to 

create, modify, maintain, or transmit 

electronic records; (2) § 11.30 specifies 

procedures and controls for persons 

who use open systems to create, modify, 

maintain, or transmit electronic records; 

and (3) § 11.50 specifies procedures and 

controls for persons who use electronic 

signatures. 

Regulations in subpart C (§§ 11.100 

through 11.300) require specific controls 

to ensure the security and integrity of 

electronic signatures based upon use of 

identification codes in combination 

with passwords. 

On March 2, 2023 (88 FR 13018) 

(Docket No. FDA–2019–N–0646), we 

revised the regulations. Before using an 

electronic signature in an electronic 

record required by FDA, a person must 

submit a letter of nonrepudiation to 

FDA (§ 11.100(c)). Letters of 

nonrepudiation are required under 

§ 11.100(c)(1) to certify that a person’s 

electronic signatures are intended to be 

the legally binding equivalent of 

traditional handwritten signatures. The 

regulations were amended to update the 

address for submission of a certification 

in paper form and to provide an option 

for electronic submission. The 

regulations were also amended to 

communicate that information on where 

to submit the certification may be found 

on FDA’s website, currently available at: 

https://www.fda.gov/industry/aboutesg/appendix-g-letters-non-repudiationagreement. 

In the Federal Register of September 

19, 2023 (88 FR 64441), we published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. 

We estimate the burden of this 

collection of information as follows: 

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 

§ 11.100; submission of nonrepudiation letters ................... 5,000 1 5,000 1 5,000 

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

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR section Number of 

recordkeepers 

Number of 

record per 

recordkeepers 

Total annual 

records 

Average burden 

per 

recordkeeping 

Total hours 

§ 11.10; controls for closed systems ..... 2,500 1 2,500 20 50,000 

§ 11.30; controls for open systems ........ 2,500 1 2,500 20 50,000 

§ 11.50; signature manifestations .......... 5,000 1 5,000 20 100,000 

§ 11.300; controls for identifications and 

passwords .......................................... 5,000 1 5,000 20 100,000 

Total ................................................ .............................. .............................. .............................. .............................. 300,000 

1 There 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 have increased our 

estimated burden. We assume 5,000 

nonrepudiation letters will be submitted 

annually. We arrived at this figure by 

looking at the average number of 

nonrepudiation letters received through 

March 2023. We further assume that 

half of the estimated respondents will 

establish controls for open systems and 

half will establish controls for closed 

systems. Finally, we assume all 

respondents will establish controls for 

the remaining technical specifications 

required by the regulations. 

Dated: January 8, 2024. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2024–00406 Filed 1–10–24; 8:45 am] 

BILLING CODE 4164–01–P 


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