Federal Register / Vol. 89, No. 236 / Monday, December 9, 2024 / Notices 97623 

Authority: 22 U.S.C. 7105. 

Mary C. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2024–28819 Filed 12–6–24; 8:45 am] 

BILLING CODE 4184–47–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for Office of Management 

and Budget Review; Child Support 

Portal Registration (Office of 

Management and Budget #: 0970–0370) 

AGENCY: Office of Child Support 

Services, Administration for Children 

and Families, U.S. Department of Health 

and Human Services. 

ACTION: Request for public comments. 

SUMMARY: The Office of Child Support 

Services (OCSS), Administration for 

Children and Families (ACF), is 

requesting the federal Office of 

Management and Budget (OMB) 

approve the ‘‘Child Support Portal 

Registration,’’ with minor revisions, for 

an additional three years. The OCSS 

Child Support Portal (‘‘Portal’’) contains 

applications to help state child support 

agencies administer their programs. 

Authorized Portal users must register 

with OCSS to access Portal applications 

and provide OCSS with certain Portal 

application preferences. The current 

OMB approval expires on February 28, 

2025. 

DATES: Comments due January 8, 2025. 

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 infocollection@

acf.hhs.gov. Identify all emailed 

requests by the title of the information 

collection. 

SUPPLEMENTARY INFORMATION: 

Description: OCSS maintains the 

Portal, which contains various 

applications through which authorized 

users may view, update, upload, or 

download information for child support 

purposes. Authorized users must 

register to access the Portal. The OCSS 

Portal authenticates registrants and then 

creates secure profiles for authorized 

users for employers, insurers, and 

financial institutions based on 

information provided in the Employer 

Services Profile and Insurance Match 

Debt Inquiry Portal Agreement and 

Profile forms. Information provided in 

the electronic National Medical Support 

Notice (e-NMSN), the electronic 

Incoming Withholding Order (e-IWO), 

and the Federally Assisted State 

Transmitted (FAST) Levy Financial 

Institution Profile forms gives OCSS the 

necessary information to set up the 

respective program user’s process and 

capture preferences. State child support 

agencies manage and authenticate 

authorization for individual users via 

the state proxy server; therefore, a Portal 

Registration form is not required. State 

users must, however, provide OCSS 

with their respective Portal preferences. 

The information OCSS collects for the 

Portal registration and profiles remains 

the same but they underwent minor 

clarification revisions and edits to 

update ‘‘Office of Child Support 

Enforcement (OCSE)’’ to ‘‘Office of 

Child Support Services (OCSS).’’ OCSS 

revised the ‘‘Registration Screen’’ 

burden after the 60-day notice 

published to correctly reflect the current 

number of respondents and removed 

‘‘agreement’’ from the Employer 

Services Profile form. OCSS also 

removed the e-NMSN Plan 

Administrator form because there are no 

respondents. 

Respondents: Employers, Financial 

Institutions, Insurers, and State Child 

Support Agencies. 

ANNUAL BURDEN ESTIMATES

Information collection instrument 

Total annual 

estimated 

number of 

respondents 

Total annual 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Total annual 

burden hours 

Portal Registration Screens ............................................................................. 16,268 1 0.15 2,440.20 

Employer Services Profile ................................................................................ 20,040 1 0.08 1,603.20

e-NMSN: Employer Profile ............................................................................... 20 1 0.22 4.40 

e-NMSN: State Profile ..................................................................................... 4 1 0.22 0.88 

e-IWO Employer/Payroll Provider Profile ........................................................ 117 1 0.08 9.36 

Insurance Match Debt Inquiry Agreement and Profile .................................... 6 1 0.08 0.48 

FAST Levy Financial Institution Profile ............................................................ 2 1 0.08 0.16 


ddrumheller on DSK120RN23PROD with NOTICES1
97624 Federal Register / Vol. 89, No. 236 / Monday, December 9, 2024 / Notices 

Estimated Total Annual Burden 

Hours: 4,058.68. 

Authority: 42 U.S.C. 653(m)(2) and 44 

U.S.C. 3554. 

Mary C. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2024–28761 Filed 12–6–24; 8:45 am] 

BILLING CODE 4184–41–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–0481] 

Standardized Format for Electronic 

Submission of Marketing Application 

Content for the Planning of 

Bioresearch Monitoring Inspections for 

Center for Drug Evaluation and 

Research Submissions; Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing the availability of the 

guidance for industry entitled 

‘‘Standardized Format for Electronic 

Submission of NDA and BLA Content 

for the Planning of Bioresearch 

Monitoring (BIMO) Inspections for 

CDER Submissions.’’ This guidance 

describes the electronic submission of 

certain data and information in 

standardized formats. This information 

is used by the Center for Drug 

Evaluation and Research (CDER) in the 

planning of, and by FDA’s Office of 

Inspections and Investigations (OII) in 

the conduct of, BIMO inspections. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on December 9, 2024. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

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– 

2018–D–0481 for ‘‘Standardized Format 

for Electronic Submission of NDA and 

BLA Content for the Planning of 

Bioresearch Monitoring (BIMO) 

Inspections for CDER Submissions.’’ 

Received comments will be placed in 

the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

http://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 

‘‘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. 

You may submit comments on any 

guidance at any time ((see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of this guidance to the Division 

of Drug Information, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Emily Gebbia, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993–0002, 240–402–0980. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Standardized Format for Electronic 

Submission of NDA and BLA Content 

for the Planning of Bioresearch 

Monitoring Inspections (BIMO) for 

CDER Submissions.’’ This guidance 

describes the electronic submission of 

certain data and information in 

standardized formats. CDER uses the 

data and information described in the 

guidance to plan BIMO inspections. The 

guidance addresses major (i.e., pivotal) 

studies used to support safety and 

efficacy claims in new drug applications 

(NDAs), biologic license applications 

(BLAs) regulated by CDER, as well as 

supplements containing new clinical 

study reports. 


ddrumheller on DSK120RN23PROD with NOTICES1