Federal Register / Vol. 89, No. 237 / Tuesday, December 10, 2024 / Notices 99265 

the individual under evaluation’s 

separation from employment, or three 

years—whichever occurs first. Longer 

retention is authorized if required for 

business use. 

ADMINISTRATIVE, TECHNICAL, AND PHYSICAL

SAFEGUARDS: 

Paper records are secured by lock and 

key and electronic files are stored on 

secure servers. The system has the 

ability to track individual user actions 

within the system. The audit and 

accountability controls are based on 

National Institute of Standards and 

Technology (NIST) and Board 

standards, which, in turn, are based on 

applicable laws and regulations. The 

controls assist in detecting security 

violations and performance or other 

issues in the system. Access to the 

system is restricted to authorized users 

within the Board who require access for 

official business purposes. Users are 

classified into different roles and 

common access and usage rights are 

established for each role. User roles are 

used to delineate between the different 

types of access requirements such that 

users are restricted to data that is 

required in the performance of their 

duties. Periodic assessments and 

reviews are conducted to determine 

whether users still require access, have 

the appropriate role, and whether there 

have been any unauthorized changes. 

RECORD ACCESS PROCEDURES: 

The Privacy Act allows individuals 

the right to access records maintained 

about them in a Board system of 

records. Your request for access must: 

(1) contain a statement that the request 

is made pursuant to the Privacy Act of 

1974; (2) provide either the name of the 

Board system of records expected to 

contain the record requested or a 

concise description of the system of 

records; (3) provide the information 

necessary to verify your identity; and (4) 

provide any other information that may 

assist in the rapid identification of the 

record you seek. 

Current or former Board employees 

may make a request for access by 

contacting the Board office that 

maintains the record. The Board 

handles all Privacy Act requests as both 

a Privacy Act request and as a Freedom 

of Information Act request. The Board 

does not charge fees to a requestor 

seeking to access or amend his/her 

Privacy Act records. 

You may submit your Privacy Act 

request to the—Secretary of the Board, 

Board of Governors of the Federal 

Reserve System, 20th Street and 

Constitution Avenue NW, Washington, 

DC 20551. 

You may also submit your Privacy Act 

request electronically by filling out the 

required information at: https://

foia.federalreserve.gov/. 

CONTESTING RECORD PROCEDURES: 

The Privacy Act allows individuals to 

seek amendment of information that is 

erroneous, irrelevant, untimely, or 

incomplete and is maintained in a 

system of records that pertains to them. 

To request an amendment to your 

record, you should clearly mark the 

request as a ‘‘Privacy Act Amendment 

Request.’’ You have the burden of proof 

for demonstrating the appropriateness of 

the requested amendment and you must 

provide relevant and convincing 

evidence in support of your request. 

Your request for amendment must: (1) 

provide the name of the specific Board 

system of records containing the record 

you seek to amend; (2) identify the 

specific portion of the record you seek 

to amend; (3) describe the nature of and 

reasons for each requested amendment; 

(4) explain why you believe the record 

is not accurate, relevant, timely, or 

complete; and (5) unless you have 

already done so in a related Privacy Act 

request for access or amendment, 

provide the necessary information to 

verify your identity. 

NOTIFICATION PROCEDURES: 

Same as ‘‘Access procedures’’ above. 

You may also follow this procedure in 

order to request an accounting of 

previous disclosures of records 

pertaining to you as provided for by 5 

U.S.C. 552a(c). 

EXEMPTIONS PROMULGATED FOR THE SYSTEM: 

Certain portions of this system of 

records may be exempted from 5 U.S.C. 

552a(c)(3), (d), (e)(1), (e)(4)(G), (H), and 

(I), and (f) of the Privacy Act pursuant 

to 5 U.S.C. 552a(k)(5). 

HISTORY: 

This SORN was previously published 

in the Federal Register at 73 FR 24984 

at 25003–04 (May 6, 2008). The SORN 

was also amended to incorporate two 

new routine uses required by OMB at 83 

FR 43872 (August 28, 2018). 

Board of Governors of the Federal 

Reserve System. 

Ann E. Misback, 

Secretary of the Board. 

[FR Doc. 2024–28926 Filed 12–9–24; 8:45 am] 

BILLING CODE 6210–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Supplemental Evidence and Data 

Request on Recurrent Nephrolithiasis 

in Adults and Children: Comparative 

Effectiveness of Preventive Medical 

Strategies 

AGENCY: Agency for Healthcare Research 

and Quality (AHRQ), HHS. 

ACTION: Request for supplemental 

evidence and data submission. 

SUMMARY: The Agency for Healthcare 

Research and Quality (AHRQ) is seeking 

scientific information submissions from 

the public. Scientific information is 

being solicited to inform our review on 

Recurrent Nephrolithiasis in Adults and 

Children: Comparative Effectiveness of 

Preventive Medical Strategies, which is 

currently being conducted by the 

AHRQ’s Evidence-based Practice 

Centers (EPC) Program. Access to 

published and unpublished pertinent 

scientific information will improve the 

quality of this review. 

DATES: Submission Deadline on or 

before January 9, 2025. 

ADDRESSES: 

Email submissions: epc@

ahrq.hhs.gov. 

Print submissions: 

Mailing Address: Center for Evidence 

and Practice Improvement, Agency for 

Healthcare Research and Quality, 

ATTN: EPC SEADs Coordinator, 5600 

Fishers Lane, Mail Stop 06E53A, 

Rockville, MD 20857. 

Shipping Address (FedEx, UPS, etc.): 

Center for Evidence and Practice 

Improvement, Agency for Healthcare 

Research and Quality, ATTN: EPC 

SEADs Coordinator, 5600 Fishers 

Lane, Mail Stop 06E77D, Rockville, 

MD 20857. 

FOR FURTHER INFORMATION CONTACT: 

Kelly Carper, Telephone: 301–427–1656 

or Email: epc@ahrq.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Agency for Healthcare Research and 

Quality has commissioned the 

Evidence-based Practice Centers (EPC) 

Program to complete a review of the 

evidence for Recurrent Nephrolithiasis 

in Adults and Children: Comparative 

Effectiveness of Preventive Medical 

Strategies. AHRQ is conducting this 

review pursuant to Section 902 of the 

Public Health Service Act, 42 U.S.C. 

299a. 

The EPC Program is dedicated to 

identifying as many studies as possible 

that are relevant to the questions for 


khammond on DSK9W7S144PROD with NOTICES
99266 Federal Register / Vol. 89, No. 237 / Tuesday, December 10, 2024 / Notices 

each of its reviews. In order to do so, we 

are supplementing the usual manual 

and electronic database searches of the 

literature by requesting information 

from the public (e.g., details of studies 

conducted). We are looking for studies 

that report on Recurrent Nephrolithiasis 

in Adults and Children: Comparative 

Effectiveness of Preventive Medical 

Strategies. The entire research protocol 

is available online at: https://

effectivehealthcare.ahrq.gov/products/ 

kidney-stones/protocol. 

This is to notify the public that the 

EPC Program would find the following 

information on Recurrent 

Nephrolithiasis in Adults and Children: 

Comparative Effectiveness of Preventive 

Medical Strategies helpful: 

D A list of completed studies that 

your organization has sponsored for this 

topic. In the list, please indicate 

whether results are available on 

ClinicalTrials.gov along with the 

ClinicalTrials.gov trial number. 

D For completed studies that do not 

have results on ClinicalTrials.gov, a 

summary, including the following 

elements, if relevant: study number, 

study period, design, methodology, 

indication and diagnosis, proper use 

instructions, inclusion and exclusion 

criteria, primary and secondary 

outcomes, baseline characteristics, 

number of patients screened/eligible/ 

enrolled/lost to follow-up/withdrawn/ 

analyzed, effectiveness/efficacy, and 

safety results. 

D A list of ongoing studies that your 

organization has sponsored for this 

topic. In the list, please provide the 

ClinicalTrials.gov trial number or, if the 

trial is not registered, the protocol for 

the study including, if relevant, a study 

number, the study period, design, 

methodology, indication and diagnosis, 

proper use instructions, inclusion and 

exclusion criteria, and primary and 

secondary outcomes. 

D Description of whether the above 

studies constitute ALL Phase II and 

above clinical trials sponsored by your 

organization for this topic and an index 

outlining the relevant information in 

each submitted file. 

Your contribution is very beneficial to 

the Program. Materials submitted must 

be publicly available or able to be made 

public. Materials that are considered 

confidential; marketing materials; study 

types not included in the review; or 

information on topics not included in 

the review cannot be used by the EPC 

Program. This is a voluntary request for 

information, and all costs for complying 

with this request must be borne by the 

submitter. 

The draft of this review will be posted 

on AHRQ’s EPC Program website and 

available for public comment for a 

period of 4 weeks. If you would like to 

be notified when the draft is posted, 

please sign up for the email list at: 

https://effectivehealthcare.ahrq.gov/ 

email-updates. 

The review will answer the following 

questions. This information is provided 

as background. AHRQ is not requesting 

that the public provide answers to these 

questions. 

Key Questions (KQ) 

KQ 1: What is the comparative 

effectiveness of preventive treatment 

with diet or pharmacologic agents in 

nonpregnant children and adults with 

history of nephrolithiasis? 

a. Does effectiveness vary by stone 

composition, diet assessment, blood or 

urine chemistry, or genetic testing 

performed prior to treatment? 

b. Does effectiveness vary by blood or 

urine chemistry or genetic testing 

performed as followup after treatment is 

initiated? 

KQ 2: What are the comparative 

harms of preventive treatment with diet 

or pharmacologic agents in nonpregnant 

children and adults with history of 

nephrolithiasis? 

a. Do harms vary by stone 

composition, diet assessment, blood or 

urine chemistry, or genetic testing 

performed prior to treatment? 

b. Do harms vary by blood or urine 

chemistry or genetic testing performed 

as followup after treatment is initiated? 

KQ 3: What is the comparative 

effectiveness of surveillance imaging 

strategies in nonpregnant children and 

adults with history of nephrolithiasis? 

a. Does effectiveness vary with 

preventive treatment? 

b. Does effectiveness vary by timing of 

imaging? 

KQ 4: What are the comparative 

harms of surveillance imaging strategies 

in nonpregnant children and adults 

with history of nephrolithiasis? 

a. Do harms vary with preventive 

treatment? 

b. Do harms vary by timing of 

imaging? 

Contextual Question (CQ) 

CQ 1: What is the natural history of 

kidney stone recurrence in children and 

adults? 

PICOTS (Populations, Interventions, 

Comparators, Outcomes, Timing, and 

Setting) 

DETAILED INCLUSION AND EXCLUSION CRITERIA FOR SYSTEMATIC REVIEW

Category Include Exclude 

Populations ............... All KQs: Nonpregnant children and adults with a history of 

nephrolithiasis.

All KQs: Children and adults without a history of 

nephrolithiasis; pregnant persons; persons receiving 

treatment for acute renal colic or for stone removal or 

expulsion. 

Interventions ............. KQ 1, 1a, 1b, 2, 2a, 2b: Dietary and/or pharmacological 

treatment, including dietary supplements and FDA-approved prescription or OTC drugs (Appendix A).

KQ 1a, 2a: Eligible interventions along with evaluation of 

stone composition, dietary intake, genetic testing, or 

blood or urine chemistries before treatment is started.

KQ 1b, 2b: Eligible interventions along with evaluation of 

genetic testing or blood and urine chemistries after treatment initiation.

KQ 3, 3a, 3b, 4, 4a, 4b: Followup imaging when used for 

routine surveillance (CT scan, renal ultrasound, abdominal radiograph) to detect radiographic stone recurrence, 

size, composition, location, or shape.

KQs 1, 2: Nondietary and nonpharmacological interventions, including behavioral interventions aimed to improve treatment adherence; interventions for the acute 

treatment of kidney stones (e.g., surgery, lithotripsy, 

medical expulsion therapy). Prescriptions drugs and OTC 

medications that are not FDA-approved or available in 

the United States. 

KQ 3, 4: Imaging not used specifically for surveillance of 

kidney stones. 

Comparators ............. KQ 1, 1a, 1b, 2, 2a, 2b: Placebo, usual diet, no preventive 

treatment (for effectiveness); other eligible intervention 

(for comparative effectiveness).

All KQs: No comparator (single arm study). 


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Federal Register / Vol. 89, No. 237 / Tuesday, December 10, 2024 / Notices 99267 

DETAILED INCLUSION AND EXCLUSION CRITERIA FOR SYSTEMATIC REVIEW—Continued 

Category Include Exclude 

KQ 3, 3a, 3b, 4, 4a, 4b: Eligible followup imaging for routine surveillance of kidney stones, no followup imaging.

Outcomes ................. All KQs: Patient-centered health outcomes: Incident symptomatic stones, urinary tract obstruction with acute renal 

impairment, end-stage renal disease, urinary tract infection, stone-removal procedures/surgery, procedure-related morbidity, emergency department visits and hospitalizations, quality of life, missed school or work, preventive treatment-related adverse events, imaging-related adverse events, serious adverse events, 

discontinuations due to adverse events.

KQ 1, 1a, 1b, 3, 3a, 3b: Blood or urine chemistry measures, urine supersaturation measures, acute pain. 

Intermediate outcomes: Growth of existing stones, incident 

radiographic stones, radiation exposure, incidental imaging findings.

Timing ....................... KQ 1, 3: Studies that measure outcomes at least 12 

months after baseline.

KQ 2, 4: Followup not limited. 

KQ 1, 3: Studies of less than 12-months duration. 

Setting ...................... Outpatient clinical settings including primary care, urology, 

nephrology, or other specialty stone clinics; countries 

with HDI12 of very high (Appendix B).

Inpatient settings; Countries with HDI other than very high. 

Study Designs, Publication Types, and 

Language.

All KQs: Published in peer-reviewed literature, unpublished 

studies with enough information about methods to determine risk of bias; English language. RCTs; for comparisons lacking sufficient RCT evidence, NRSIs with concurrent comparator group and primary study aim/outcome to assess a dietary or pharmacologic intervention 

or surveillance imaging approach are eligible.

All KQs: Interrupted time series, case series, narrative reviews, editorials, and commentaries are not eligible; systematic reviews are not eligible but will be reviewed to 

determine whether any included studies are eligible. 

Studies with fewer than 30 participants at baseline per 

study arm. Studies published in languages other than 

English. 

KQ 2: Studies designed to report epidemiologic associations between dietary factors and stone incidence. 

CT = computed tomography; FDA = U.S. Food and Drug Administration; HDI = United Nations Development Programme Human Development

Index; KQ = key question; NRSI = nonrandomized study of intervention; OTC = over-the-counter; RCT = randomized controlled trial. 

Dated: December 4, 2024. 

Marquita Cullom, 

Associate Director. 

[FR Doc. 2024–28933 Filed 12–9–24; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Materials; 

Availability for Access 

AGENCY: National Institute of Allergy 

and Infectious Diseases, National 

Institutes of Health, HHS. 

ACTION: Notice. 

SUMMARY: The material listed below is 

owned by an agency of the U.S. 

Government and is available for transfer 

to achieve expeditious use and/or 

commercialization of results of federally 

funded research and development. 

FOR FURTHER INFORMATION CONTACT: 

Access information may be obtained by 

communicating with the Technology 

Transfer and Intellectual Property 

Office, National Institute of Allergy and 

Infectious Diseases, 5601 Fishers Lane, 

Rockville, MD 20852 by contacting 

Benjamin Hurley at 240–669–5092 or 

benjamin.hurley@nih.gov. 

SUPPLEMENTARY INFORMATION: 

Royalty-Free Starting Material (MVAclone 1) for the Clinical Development, 

Evaluation, and Commercialization of a 

Viable Mpox Vaccine 

Worldwide, leading health authorities 

have cited the growing need for a 

commitment to equitable vaccine access 

and its role in curtailing future 

epidemics—a vision that cannot be 

realized without significant 

improvements in the speed, scale, and 

access of vaccine manufacturing and 

deployment in historically underserved 

regions. For at-risk populations and 

those with contraindications to 

commonly deployed vaccines, such 

initiatives are even more vital. 

Modified vaccinia virus Ankara 

(MVA), developed more than 30 years 

ago as a highly attenuated candidate 

smallpox vaccine, was recloned at the 

U.S. National Institute of Allergy and 

Infectious Diseases (NIAID) (referred to 

here as ‘‘MVA clone-1’’) from a 1974- 

originating passage and evaluated for 

safety and immunogenicity in both 

normal and partially immune-deficient 

animals. Subsequent studies verified the 

protective ability of this attenuated 

vaccine against mpox in non-human 

primates, and clinical efforts since have 

resulted in FDA approval and 

availability of a two-dose MVA vaccine 

in the U.S. 

In support of the global humanitarian 

effort to achieve equitable vaccine 

access and in light of the current public 

health emergency of international 

concern (PHEIC) declared by the World 

Health Organization in 2024—which 

has resulted in more than 500 deaths in 

the Democratic Republic of the Congo 

since the beginning of this year—the 

National Institute of Allergy and 

Infectious Diseases (NIAID) is seeking 

inquiries from parties interested in 

independent R&D and/or collaborative 

research to further develop, evaluate, 

and commercialize a viable mpox 

vaccine for distribution (particularly in 

developing nations/regions currently 

having minimal access to mpox 

vaccines) using NIH-provided starting 

material (MVA clone-1). While 

traditional licensing opportunities 

related to mpox detection are also 

available (e.g., antibodies, neutralization 

assays), NIAID will transfer the MVA 

clone-1 material in question on a 

royalty-free basis to qualified partners in 

an effort to combat the current PHEIC. 

In the event that NIAID has limited 

ability to distribute material, or if 

supply approaches exhaustion, priority 

will be given to collaborators with a 

proposed plan demonstrating, in 


khammond on DSK9W7S144PROD with NOTICES