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All KQs: Published in peer-reviewed literature, unpublished 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
99268 Federal Register / Vol. 89, No. 237 / Tuesday, December 10, 2024 / Notices 

NIAID’s sole judgment, the ability to 

develop a viable vaccine. Potential 

collaborators considered equally 

competitive in terms of capacity will 

also be evaluated based on their plans 

and intent to distribute in areas with 

immediate need, followed by the 

likelihood of the proposed plan 

contributing to the achievement of a 

self-sustaining vaccine ecosystem in 

developing nations. 

This material is available for access 

for commercial development in 

accordance with 35 U.S.C. 209 and 37 

CFR part 404, as well as for further 

development and evaluation under a 

research collaboration agreement. 

Potential Commercial Applications: 

• Prophylaxis against mpox in normal 

or high-risk populations 

• Vaccine research 

Competitive Advantages: 

• MVA clone-1 material is believed to 

be functionally and genetically 

similar to FDA-approved vaccine 

material 

• Identification of vaccine candidates 

that can elicit protective antibodies 

against mpox in normal or high-risk 

populations 

• Royalty-free access for vaccine 

development and/or research 

Development Stage: 

• Pre-clinical 

NIH Contributor: Bernard Moss, MD, 

Ph.D. 

Publications: 

• Earl PL, et al. (2004) 

Immunogenicity of a highly attenuated 

MVA smallpox vaccine and protection 

against monkeypox. Nature. 428:182. 

• Wyatt LS, et al. (2004) Highly 

attenuated smallpox vaccine protects 

mice with and without immune 

deficiencies against pathogenic vaccinia 

virus challenge. Proc Nat Acad Sci 

USA.101:4590. 

• Earl PL, et al. (2003) Development 

and use of a vaccinia virus 

neutralization assay based on flow 

cytometric detection of green 

fluorescent protein. J Virol. 77:10684. 

Intellectual Property: N/A. 

Technology Transfer Specialist: To 

discuss access to this technology, please 

contact Benjamin Hurley at 

(benjamin.hurley@nih.gov). 

Collaborative Research Opportunity: 

The National Institute of Allergy and 

Infectious Diseases 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 using this material. 

Please contact Benjamin Hurley at 240– 

669–5092 or benjamin.hurley@nih.gov. 

Dated: December 4, 2024. 

Jeremiah D. Mitzelfelt, 

Acting Deputy Director, Technology Transfer 

and Intellectual Property Office, National 

Institute of Allergy and Infectious Diseases. 

[FR Doc. 2024–28924 Filed 12–9–24; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF THE INTERIOR 

Bureau of Land Management 

[LLHQ430000.L12200000.PM0000; OMB 

Control No. 1004–0217] 

Agency Information Collection 

Activities; Submission to the Office of 

Management and Budget for Review 

and Approval; Surveys and Focus 

Groups To Support OutcomesFocused Management (Recreation 

Survey and Focus Groups) 

AGENCY: Bureau of Land Management, 

Interior. 

ACTION: Notice of information collection; 

request for comment. 

SUMMARY: In accordance with the 

Paperwork Reduction Act of 1995 

(PRA), the Bureau of Land Management 

(BLM) has submitted an information 

collection request (ICR) to the Office of 

Management and Budget (OMB) for 

review. 

DATES: Interested persons are invited to 

submit comments on or before January 

9, 2025. 

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. 

FOR FURTHER INFORMATION CONTACT: To 

request additional information about 

this ICR, contact Matt Blocker, Outdoor 

Recreation Planner, by email at 

mblocker@blm.gov, or by telephone at 

(385) 341–3403. Individuals who are 

hearing or speech impaired may call the 

Federal Relay Service at 1–800–877– 

8339 for TTY assistance. You may also 

view the ICR at http://www.reginfo.gov/ 

public/do/PRAMain. 

SUPPLEMENTARY INFORMATION: In 

accordance with the PRA (44 U.S.C. 

3501 et seq.) and 5 CFR 1320.8(d)(1)), 

we provide the general public and other 

Federal agencies with an opportunity to 

comment on new, proposed, revised, 

and continuing collections of 

information. This helps us assess the 

impact of our information collection 

requirements and minimize the public’s 

reporting burden. It also helps the 

public understand our information 

collection requirements and provide the 

requested data in the desired format. 

A Federal Register notice with a 60- 

day public comment period soliciting 

comments on this collection of 

information was published on July 5, 

2024 (89 FR 55653). No comments were 

received. 

As part of our continuing effort to 

reduce paperwork and respondent 

burdens, we are again soliciting 

comments from the public and other 

Federal agencies on the proposed ICR 

that is described below. We are 

especially interested in public comment 

addressing the following: 

(1) Whether the collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information will have practical utility; 

(2) The accuracy of our estimate of the 

burden for this collection of 

information, including the validity of 

the methodology and assumptions used; 

(3) Ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and 

(4) How might the agency minimize 

the burden of the collection of 

information on those who are to 

respond, including through the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology, e.g., permitting 

electronic submission of response. 

Comments that you submit in 

response to this notice are a matter of 

public record. Before including your 

address, phone number, email address, 

or other personal identifying 

information in your comment, you 

should be aware that your entire 

comment—including your personal 

identifying information—may be made 

publicly available at any time. While 

you can ask us in your comment to 

withhold your personal identifying 

information from public review, we 

cannot guarantee that we will be able to 

do so. 

Abstract: Information will be 

collected from visitors of public lands 

and community members near public 

lands. Information gathered from 

visitors and local community residents 

will be used to inform planning 

decisions in support of BLM’s Planning 

for Recreation and Visitor Services 

Handbook H–8320–1. This request is for 

OMB to renew these surveys and focus 

groups for three (3) years. 

Title of Collection: Surveys and Focus 

Groups to Support Outcomes-Focused 


khammond on DSK9W7S144PROD with NOTICES