104188 Federal Register / Vol. 89, No. 245 / Friday, December 20, 2024 / Notices 

620 and the average burden hours per 

response increased from 0.17 to 0.33. 

• Key Personnel Minimum 

Qualifications Checklist and Attestation 

(Form A–14) 

Æ Revise the introductory text to the 

form to remove repetition and improve 

readability. 

Æ Revise Section D: Candidate 

Minimum Qualifications to: 

■ Reorganize how the minimum 

qualifications for each position are 

displayed to make it easier for the 

respondent to understand the 

requirements. 

■ Change the ‘‘Candidate does not 

meet minimum qualification’’ checkbox 

into a question that asks ‘‘Does the 

candidate meet the minimum 

qualification?’’ with yes/no options so 

that the respondent may more clearly 

communicate whether the candidate 

meets minimum qualifications. 

■ Update the qualifications for each 

position and add two new positions 

(Background Check Specialist and Lead 

Medical Coordinator) to reflect revisions 

that are under consideration for ORR’s 

residential services cooperative 

agreement. 

Æ Revise the burden estimate to 

account for an increase in the number 

of care provider facilities, a decrease in 

the number of forms submitted, and 

more accurately reflect how long it takes 

to complete the form. The annual 

number of respondents increased from 

235 to 300, the annual number of 

responses per respondent decreased 

from nine to six, and the average burden 

hours per response increased from 0.17 

to 0.42. 

• ORR Waiver Request (Form A–15) 

Æ Add a burden statement at the top 

of the form. 

Æ Break the form into several sections 

to make it more digestible for 

respondents. 

Æ Rephrase several field labels for 

clarity and succinctness. 

Æ Add a field for the respondent to 

specify whether they are a care provider 

facility or a home study or post-release 

service provider. 

Æ Change the ‘‘Type of Facility/ 

Provider’’ field label to ‘‘Level of Care’’ 

and update the related checkbox options 

to better reflect care provider facility 

levels of care. 

Æ Add a place where respondents can 

upload a supervision or training plan 

when applicable for their request. 

Æ Revise the burden estimate to 

account for an increase in the number 

of care provider facilities. The annual 

number of respondents increased from 

235 to 300. 

Revisions to Burden Estimates Only for 

Existing Forms 

• Authorization for Release of 

Records (Form A–5) 

Æ Revise the burden estimate to 

account for an increase in the number 

records requests submitted and more 

accurately reflect how long it takes to 

complete the form. The annual number 

of respondents increased from 4,000 to 

9,620 and the average burden hours per 

response increased from 0.25 to 0.5. 

Respondents: ORR grantee and 

contractor staff; advocacy groups, faithbased organizations, researchers, and 

government officials; attorneys, legal 

service providers, child advocates, and 

government agencies; and other 

stakeholders. 

Annual Burden Estimates: 

Form 

Annual 

number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden hours 

per response 

Annual total 

burden hours 

Care Provider Facility Tour Request (Form A–1A) ......................................... 620 1 0.33 205 

Notice to Unaccompanied Children for Flores Visits (Forms A–4 and A–4s) 20 1 0.25 5 

Authorization for Release of Records (Form A–5) .......................................... 9,620 1 0.50 4,810 

Key Personnel Minimum Qualifications Checklist and Attestation (Form A– 

14) ................................................................................................................ 300 6 0.42 756 

ORR Waiver Request (Form A–15) ................................................................. 300 2 0.33 198 

Estimated Annual Burden Hours Total: .................................................... ........................ ........................ ........................ 5,974 

Comments: The Department 

specifically requests comments on (a) 

whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Consideration will be given 

to comments and suggestions submitted 

within 60 days of this publication. 

Authority: 6 U.S.C. 279; 8 U.S.C. 

1232; 45 CFR 410; Flores v. Reno 

Settlement Agreement, No. CV85–4544– 

RJK (C.D. Cal. 1996) 

Mary C. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2024–30384 Filed 12–19–24; 8:45 am] 

BILLING CODE 4184–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–3902] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Registration of 

Producers of Drugs and Listing of 

Drugs in Commercial Distribution and 

Related Collections of Information 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) 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 January 21, 

2025. 

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 0910–0045. Also include 

the FDA docket number found in 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 245 / Friday, December 20, 2024 / Notices 104189 

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. 

Registration of Producers of Drugs and 

Listing of Drugs in Commercial 

Distribution and Related Collections of 

Information 

OMB Control Number 0910–0045— 

Revision 

This information collection supports 

implementation of requirements related 

to drug establishment registration and 

listing governed by section 510 of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 360), including 

registrant reporting under section 

510(j)(3) of the FD&C Act with respect 

to listed drugs. The information 

collection also supports implementation 

of section 510(j)(3)(B) of the FD&C Act, 

which authorizes the Secretary of 

Health and Human Services (the 

Secretary), by order, to exempt from 

some or all of the section 510(j)(3) 

reporting requirements certain 

biological products or categories of 

biological products regulated under 

section 351 of the Public Health Service 

(PHS) Act if the Secretary determines 

that such reporting is not necessary to 

protect the public health. Agency 

regulations implementing drug 

establishment and registration 

provisions are found in part 207 (21 

CFR part 207) and include reporting and 

recordkeeping requirements. 

The information collection utilizes 

guidance documents intended to 

facilitate reporting and recordkeeping 

provided for by section 510 of the FD&C 

Act. All Agency guidance documents 

are issued consistent with our good 

guidance practice regulations in 21 CFR 

10.115, which provide for public 

comment at any time. To search 

available FDA guidance documents, 

visit the FDA guidance web page at 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments. Because FDA relies on 

establishment registration and drug 

listing information for several of its 

programs, complete, accurate, and upto-date information is essential to FDA’s 

role in ensuring public health. 

Respondents to the collection of 

information are domestic establishments 

that manufacture, repack, relabel, or 

salvage a drug, or an animal feed 

bearing or containing a new animal 

drug, and foreign establishments that 

manufacture, repack, relabel, or salvage 

a drug, or an animal feed bearing or 

containing a new animal drug, that is 

imported or offered for import into the 

United States. As set forth in the 

applicable regulations, when operations 

are conducted at more than one 

establishment and common ownership 

and control among all the 

establishments exists, the parent, 

subsidiary, or affiliate company may 

submit registration information for all 

establishments. Establishment 

registration information helps FDA 

identify who is manufacturing, 

repacking, relabeling, and salvaging 

drugs and where those operations are 

performed. 

Consistent with provisions in § 207.61 

(21 CFR 207.61), except as provided in 

§ 207.65 (21 CFR 207.65), all registration 

and listing information must be 

transmitted to FDA using FDA’s 

electronic drug registration and listing 

system in an electronic format that we 

can process, review, and archive. For 

more information regarding FDA’s 

Electronic Drug Registration and Listing 

System (eDRLS), including ‘‘Latest 

News’’ updates, we encourage 

respondents to visit our website at 

https://www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

electronic-drug-registration-and-listingsystem-edrls. Updated daily, a 

registration database we also maintain 

that includes a publication of currently 

registered establishments is on our 

website at https://www.fda.gov/drugs/ 

drug-approvals-and-databases/drugestablishments-current-registration-site. 

Since our last evaluation of the 

information collection, we have made 

the following modifications as a result 

of the Coronavirus Aid, Relief, and 

Economic Security (CARES) Act (Pub. L. 

116–136): 

• The scope of activity for the 

information collection now reflects 

exemptions from reporting under 

section 510(j)(3) of the FD&C Act 

applicable to: (1) blood and blood 

components for transfusion and (2) cell 

and gene therapy products, where one 

lot treats a single patient, as announced 

in the Federal Register of April 13, 2023 

(88 FR 22454) (April 2023 final order). 

• We have added recommendations 

from the guidance document entitled 

‘‘Planning for the Effects of High 

Absenteeism to Ensure Availability of 

Medically Necessary Drug Products’’ 

(March 2011) (available at https://

www.fda.gov/media/120092/download), 

to the scope of activity included in the 

collection of information. The guidance 

document is intended to encourage 

manufacturers of drug and therapeutic 

biological products, and any raw 

materials and components used in those 

products, to develop a written 

Emergency Plan (Plan) for maintaining 

an adequate supply of medically 

necessary drug products during an 

emergency that results in high employee 

absenteeism. The guidance document 

discusses the elements that should be 

covered by such a Plan and 

recommends notifications to FDA’s 

Center for Drug Evaluation and Research 

(CDER) when activating or deactivating 

a Plan. 

• Section 510(j)(3) of the FD&C Act 

requires that registrants annually report 

the amount of each listed drug that they 

manufacture, prepare, propagate, 

compound, or process (hereinafter 

manufacture) for commercial 

distribution. Section 510(j)(3) of the 

FD&C Act also authorizes the Secretary 

to require that the information be 

reported in an electronic format as 

determined by the Secretary, and that it 

be reported at the time a public health 

emergency is declared. To provide 

instruction in this regard, we issued the 

guidance document entitled ‘‘Reporting 

Amount of Listed Drugs and Biological 

Products Under Section 510(j)(3) of the 

FD&C Act’’ (February 2024) (available at 

https://www.fda.gov/media/175933/ 

download). In addition to supporting 

FDA’s response to drug shortages, the 

guidance document is also intended to 

facilitate FDA’s access to information 

useful in making decisions regarding the 

appropriate level of drug facility 

surveillance. 

• As we continue to receive similar 

information regarding animal drug 

shortages, we developed and issued the 

guidance document ‘‘Reporting and 

Mitigating Animal Drug Shortages’’ 

(Center for Veterinary Medicine GFI 

#271) (May 2023) (available at https://

www.fda.gov/media/137722/download). 

The guidance document is intended to 

assist respondents in notifying FDA 

about changes in the production of 

animal drugs that will, in turn, help the 

Agency in its efforts to prevent or 

mitigate shortages of animal drugs. 

In the Federal Register of September 

5, 2024 (89 FR 72403), we published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. On our own initiative 

however, we are noting some 

clarifications and modifications with 

regard to the information collection and 


ddrumheller on DSK120RN23PROD with NOTICES1
104190 Federal Register / Vol. 89, No. 245 / Friday, December 20, 2024 / Notices 

are therefore recharacterizing this action 

as a revision rather than an extension. 

First, we have removed the 

information collection element 

exclusively attributable to the 

development of standard operating 

procedures for providing regulatory 

submissions in an electronic format. 

The requirement to submit registration 

and listing information to FDA 

electronically has been in effect for 

more than 10 years and is now standard 

business practice. We assume that most, 

if not all, respondents to the information 

collection now implement and utilize 

electronic data systems compatible with 

FDA and invite comment on our 

assumption. FDA uses a structured 

product labeling (SPL) standard to 

support submissions through our 

electronic submission gateway (ESG). 

On our website at https://www.fda.gov/ 

industry/fda-data-standards-advisoryboard/structured-product-labelingresources, we provide informational 

resources regarding the SPL format 

standard, including Agency guidance, 

intended to assist respondents with 

technological considerations in 

submitting regulatory information to 

FDA. 

Additionally, CDER continues to 

develop and refine submission tools that 

utilize interactive data submission 

technology for a number of its programs. 

We believe most, if not all, respondents 

to the collection of information use 

these platforms to submit required drug 

registration and listing information and 

invite comment on our assumption. 

We are also clarifying that submission 

of the unique facility identifier (UFI) 

and the accompanying data elements 

referenced in section 510(b), (c), and (i) 

of the FD&C Act is included among the 

scope of activity covered by the 

information collection. The procedural 

guidance document entitled 

‘‘Specification of the Unique Facility 

Identifier (UFI) System for Drug 

Establishment Registration,’’ (November 

2014), explains that FDA’s currently 

preferred UFI for a drug establishment 

is the Data Universal Numbering System 

D–U–N–S (DUNS) number, assigned 

and managed by Dun and Bradstreet. 

FDA has been using the DUNS number 

as a registration number for drug 

establishments since its implementation 

of electronic drug registration and 

listing. The guidance document is 

available for download from our website 

at https://www.fda.gov/media/89926/ 

download. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Collection activity; authority to collect information Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden per 

response Total hours 

Initial establishment registration; §§ 207.17, 207.21, 

and 207.25.

593 2 1,186 1 ............................... 1,186 

Annual review and update of registration information (including expedited updates); § 207.29.10,480 3 31,440 0.5 (30 minutes) ....... 15,720 

Initial listing (including National Drug Code (NDC)); 

§§ 207.33, 207.41, 207.45, 207.49, 207.53, 

207.54, and 207.55.

3,040 7.28 22,130 1.5 ............................ 33,197 

June and December review and update (or certification) of listing; §§ 207.35 and 207.57.5,153 20 103,060 0.75 (45 minutes) ..... 77,295 

Waiver requests; § 207.65 ......................................... 1 1 1 0.5 (30 minutes) ....... 1 

Public disclosure exemption request; § 207.81(c) .... 30 1 30 1 ............................... 30 

Manufacturing amount information; FD&C Act section 510(j)(3).8,700 22.5 195,750 1 ............................... 195,750 

Maintenance of, and notifications associated with, 

plans to ensure availability of medically necessary drug products during emergency; FDA 

topic-specific guidance, section III.F.

2 1 2 16 ............................. 32 

Reporting and Mitigating Animal Drug Shortages; 

FDA topic-specific Guidance, section III.

30 2 60 1 ............................... 60 

Total ................................................................... ........................ ........................ 353,659 .................................. 323,271 

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

Although we denote that table 1 

reflects reporting activity, we include 

the retention and maintenance of 

corresponding records in our 

calculation and assessment of burden. 

While there are 10,480 establishments 

currently registered with FDA, 

registration and listing data is subject to 

frequent fluctuation as a result of the 

volume of activity. 

Based on our experience with the 

information collection, we estimate 593 

respondents will submit 1,186 new 

establishment registrations annually 

using the CDER Direct submission 

platform. We assume an average of 1 

hour is necessary for this activity. 

Similarly, we estimate that 10,480 

registrants will provide 31,440 annual 

reviews and updates of registration 

information (including expedited 

updates) or reviews and certifications 

that no changes have occurred. Our 

estimate includes the registration of 

establishments for both domestic and 

foreign manufacturers, repackers, 

relabelers, and drug product salvagers, 

and registration information submitted 

by anyone acting as an authorized agent 

for an establishment that manufactures, 

repacks, relabels, or salvages drugs. The 

estimate also includes an additional 80 

positron emission tomography drug 

producers who are not exempt from 

registration and approximately 30 

manufacturers of plasma derivatives. 

We assume 30 minutes is necessary for 

each annual review and update of 

registration information (including any 

expedited updates) or each review and 

certification that no changes have 

occurred. 

Although we have not received a 

request for waiver as provided for in 

§ 207.65, we retain a placeholder of 1 for 

such activity and assume 30 minutes is 

necessary to prepare and make the 

submission. Relatedly, we reduced our 

estimate of requests for exemption from 

public disclosure the information 

submitted in accordance with § 207.81 

from 100 to 30 to reflect a decrease of 

activity. 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 245 / Friday, December 20, 2024 / Notices 104191 

The reporting of manufacturing 

amount information under section 

510(j)(3) of the FD&C Act is a new 

element to the information collection. 

We assume it takes 1 hour to prepare 

and submit the necessary reporting 

information and estimate an average of 

22.5 reports will be submitted annually 

from 8,700 registrants. We exclude 

1,780 respondents from the 10,480 

registrants, (accounting for both 

biological product and drug product 

registrants) to reflect the reporting 

exemptions implemented under section 

510(j)(3)(B). Also, based on informal 

communications, we have increased the 

estimate of burden we attribute to 

preparing and submitting the requisite 

information from 15 minutes to 1 hour. 

Similarly, intending to ensure the 

availability of medically necessary drug 

products during emergencies that might 

result in high absenteeism at production 

facilities, we account for burden 

associated with the development of a 

manufacturing contingency plan as 

recommended in Agency guidance 

‘‘Planning for the Effects of High 

Absenteeism to Ensure Availability of 

Medically Necessary Drug Products,’’ 

(March 2011), referenced above. We 

assume that most respondents have 

already developed a Plan as 

recommended by the guidance 

document as a usual and customary 

business practice, and limit therefore, 

our current burden estimate to updates, 

maintenance, and the reporting to FDA 

of the activation and deactivation of the 

Plan. We assume two notifications (for 

purposes of this analysis, we consider 

an activation and a deactivation 

notification to equal one notification) 

will be submitted to CDER annually, 

and estimate each notification requires 

an average of 16 hours to prepare and 

submit. 

Finally, animal drug shortage 

information is also a new element to the 

information collection. Although not 

statutorily required, we estimate that 30 

respondents will provide 2 notifications 

annually and that it will take 1 hour to 

prepare and submit each notification as 

recommended in the guidance 

document entitled ‘‘Reporting and 

Mitigating Animal Drug Shortages,’’ 

referenced above. 

Cumulatively, these adjustments and 

modifications result in a decrease of 

67,004 responses and an increase of 

87,413 burden hours, annually. We have 

removed burden we attributed to 

developing and implementing electronic 

data systems as we now regard this 

activity as usual and customary, 

however we have increased our estimate 

of the time needed for some of the 

activities to account for corresponding 

record maintenance. 

Dated: December 16, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–30355 Filed 12–19–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

National Vaccine Injury Compensation 

Program; List of Petitions Received 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: HRSA is publishing this 

notice of petitions received under the 

National Vaccine Injury Compensation 

Program (the Program), as required by 

the Public Health Service (PHS) Act, as 

amended. While the Secretary of HHS is 

named as the respondent in all 

proceedings brought by the filing of 

petitions for compensation under the 

Program, the United States Court of 

Federal Claims is charged by statute 

with responsibility for considering and 

acting upon the petitions. 

FOR FURTHER INFORMATION CONTACT: For 

information about requirements for 

filing petitions, and the Program in 

general, contact Lisa L. Reyes, Clerk of 

Court, United States Court of Federal 

Claims, 717 Madison Place NW, 

Washington, DC 20005, (202) 357–6400. 

For information on HRSA’s role in the 

Program, contact the Director, National 

Vaccine Injury Compensation Program, 

5600 Fishers Lane, Room 8W–25A, 

Rockville, Maryland 20857; (301) 443– 

6593, or visit our website at: http://

www.hrsa.gov/vaccinecompensation/ 

index.html. 

SUPPLEMENTARY INFORMATION: The 

Program provides a system of no-fault 

compensation for certain individuals 

who have been injured by specified 

childhood vaccines. Subtitle 2 of title 

XXI of the PHS Act, 42 U.S.C. 300aa– 

10 et seq., provides that those seeking 

compensation are to file a petition with 

the United States Court of Federal 

Claims and to serve a copy of the 

petition to the Secretary of HHS, who is 

named as the respondent in each 

proceeding. The Secretary has delegated 

this responsibility under the Program to 

HRSA. The Court is directed by statute 

to appoint special masters who take 

evidence, conduct hearings as 

appropriate, and make initial decisions 

as to eligibility for, and amount of, 

compensation. 

A petition may be filed with respect 

to injuries, disabilities, illnesses, 

conditions, and deaths resulting from 

vaccines described in the Vaccine Injury 

Table (the Table) set forth at 42 CFR 

100.3. This Table lists for each covered 

childhood vaccine the conditions that 

may lead to compensation and, for each 

condition, the time period for 

occurrence of the first symptom or 

manifestation of onset or of significant 

aggravation after vaccine 

administration. Compensation may also 

be awarded for conditions not listed in 

the Table and for conditions that are 

manifested outside the time periods 

specified in the Table, but only if the 

petitioner shows that the condition was 

caused by one of the listed vaccines. 

Section 2112(b)(2) of the PHS Act, 42 

U.S.C. 300aa–12(b)(2), requires that 

‘‘[w]ithin 30 days after the Secretary 

receives service of any petition filed 

under section 2111 the Secretary shall 

publish notice of such petition in the 

Federal Register.’’ Set forth below is a 

list of petitions received by HRSA on 

October 1, 2024, through October 31, 

2024. This list provides the name of the 

petitioner, city, and State of vaccination 

(if unknown then the city and State of 

the person or attorney filing the claim), 

and case number. In cases where the 

Court has redacted the name of a 

petitioner and/or the case number, the 

list reflects such redaction. 

Section 2112(b)(2) also provides that 

the special master ‘‘shall afford all 

interested persons an opportunity to 

submit relevant, written information’’ 

relating to the following: 

1. The existence of evidence ‘‘that 

there is not a preponderance of the 

evidence that the illness, disability, 

injury, condition, or death described in 

the petition is due to factors unrelated 

to the administration of the vaccine 

described in the petition,’’ and 

2. Any allegation in a petition that the 

petitioner either: 

a. ‘‘[S]ustained, or had significantly 

aggravated, any illness, disability, 

injury, or condition not set forth in the 

Vaccine Injury Table but which was 

caused by’’ one of the vaccines referred 

to in the Table, or 

b. ‘‘[S]ustained, or had significantly 

aggravated, any illness, disability, 

injury, or condition set forth in the 

Vaccine Injury Table the first symptom 

or manifestation of the onset or 

significant aggravation of which did not 

occur within the time period set forth in 

the Table but which was caused by a 

vaccine’’ referred to in the Table. 


ddrumheller on DSK120RN23PROD with NOTICES1