35100 Federal Register / Vol. 86, No. 124 / Thursday, July 1, 2021 / Notices 

and gender influences on mechanisms 

and outcomes of chronic diseases are 

incomplete, reducing the specificity, 

sensitivity, and efficacy of diagnostic 

tests and treatments for women. 

Research on rare diseases that are more 

prevalent in women or only occur in 

women faces similar challenges. 

3. Stagnant Cervical Cancer Survival 

Rates 

In the United States it is estimated 

approximately 12,000 new cases of 

cervical cancer occur each year. Human 

papillomavirus (HPV) is the cause of 

cervical cancer as well as a large 

percentage of cancers of the vulva, 

vagina, penis, anus, rectum, and 

oropharynx.13 Despite cancer 

prevention efforts through HPV 

vaccination and cervical cancer 

screening, incidence and mortality from 

this malignancy have been stable for the 

last two decades. Communities 

historically under-represented in 

medicine are disproportionately 

burdened by this disease. The incidence 

rate of cervical cancer is 30 percent 

higher in Black women 14 and Black 

women persistently present at later 

stages at diagnosis.15 The overall 5-year 

relative survival rate for cervical cancer 

among Black women is 56 percent, 

compared with 68 percent among White 

women.14

Information Requested 

This Request for Information (RFI) 

invites the scientific community, health 

professionals, professional societies, 

and the general public to provide 

comments and testimonies on research 

gaps, pitfalls in clinical practices, and 

obtaining real-life testimonial 

experiences (direct or indirect) related 

to any or all of the listed public health 

issues. Responses are welcome from 

associations and professional 

organizations as well as individuals. 

This RFI is for planning purposes 

only and should not be construed as a 

solicitation or an obligation on the 

federal government, the National 

Institutes of Health, or individual NIH 

Institutes or Centers. Responses to this 

RFI Notice are voluntary. The NIH will 

use the information submitted in 

response to this RFI at its discretion. 

NIH will analyze the information 

submitted and may share it internally or 

in reports. The information may or may 

not be reflected in future solicitations, 

as appropriate and at the government’s 

discretion. NIH advises respondents the 

government is under no obligation to 

acknowledge receipt of the information 

provided and will not provide feedback 

to respondents. The federal government 

will not pay for the preparation of any 

information submitted or for the 

government’s use. NIH will not consider 

submitted information confidential. 

Additionally, the government cannot 

guarantee the confidentiality of the 

information provided. 

References 

1. Hoyert DL. Maternal Mortality Rates in the 

United States, 2019. NCHS Health EStats. 2021. 

2. Collier AY, Molina RL. Maternal Mortality 

in the United States: Updates on Trends, 

Causes, and Solutions. Neoreviews. 

2019;20(10):e561-e574. 

3. Raghupathi W, Raghupathi V. An 

Empirical Study of Chronic Diseases in 

the United States: A Visual Analytics 

Approach. Int J Environ Res Public 

Health. 2018;15(3). 

4. Gaffney DK, Hashibe M, Kepka D, Maurer 

KA, Werner TL. Too many women are 

dying from cervix cancer: Problems and 

solutions. Gynecol Oncol. 

2018;151(3):547–554. 

5. National Institutes of Health, Office of 

Research on Women’s Health. Maternal 

Morbidity and Mortality What do we 

Know? How are we Addressing it? 20– 

OD–80692020:1–16. 

6. Petersen EE DN, Goodman D, et al. Vital 

Signs: Pregnancy-Related Deaths, United 

States, 2011–2015, and Strategies for 

Prevention, 13 States, 2013–2017. 

MMWR Morb Mortal Wkly Rep 

2019(68):423–429. 

7. GDB 2015 Maternal Mortality 

Collaborators. Global, regional, and 

national levels of maternal mortality, 

1990–2015: A systematic analysis for the 

Global Burden of Disease Study 2015. 

Lancet. 2016;388(10053):1775–1812. 

8. New York City Department of Health and 

Mental Hygiene Bureau of Maternal, 

Infant, and Reproductive Health. 

Pregnancy-Associated Mortality, New 

York City, 2006–2010. 

9. Howell EA, Egorova NN, Balbierz A, 

Zeitlin J, Hebert PL. Site of delivery 

contribution to black-white severe 

maternal morbidity disparity. American 

Journal of Obstetrics and Gynecology. 

2016;215(2):143–152. 

10. National Center for Chronic Disease 

Prevention and Health Promotion. 

Chronic Diseases in America. https://

www.cdc.gov/chronicdisease/resources/ 

infographic/chronic-diseases.htm. 

Updated 1/12/2021. 

11. Bade BC, DeRycke EC, Ramsey C, et al. 

Sex Differences in Veterans Admitted to 

the Hospital for Chronic Obstructive 

Pulmonary Disease Exacerbation. Ann 

Am Thorac Soc. 2019;16(6):707–714. 

12. De Bellis A, De Angelis G, Fabris E, 

Cannata A, Merlo M, Sinagra G. Genderrelated differences in heart failure: 

Beyond the ‘‘one-size-fits-all’’ paradigm. 

Heart Fail Rev. 2020;25(2):245–255. 

13. Viens LJ HS, Watson M, et al. Human 

Papillomavirus–Associated Cancers— 

United States, 2008–2012. Weekly 

2016(65):661–666. 

14. DeSantis CE, Miller KD, Goding Sauer A, 

Jemal A, Siegel RL. Cancer statistics for 

African Americans, 2019. CA Cancer J 

Clin. 2019;69(3):211–233. 

15. Benard VB, Watson M, Saraiya M, et al. 

Cervical cancer survival in the United 

States by race and stage (2001–2009): 

Findings from the CONCORD–2 study. 

Cancer. 2017;123 Suppl 24(Suppl 

24):5119–5137. 

Dated: June 25, 2021. 

Lawrence A. Tabak, 

Principal Deputy Director, National Institutes 

of Health. 

[FR Doc. 2021–14151 Filed 6–30–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The invention listed below is 

owned by an agency of the U.S. 

Government and is available for 

licensing to achieve expeditious 

commercialization of results of 

federally-funded research and 

development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing. 

FOR FURTHER INFORMATION CONTACT: 

David Yang at 240–695–6406 or 

yangp3@mail.nih.gov. Licensing 

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; tel. 301–496– 

2644. A signed Confidential Disclosure 

Agreement will be required to receive 

copies of unpublished information 

related to the invention. 

SUPPLEMENTARY INFORMATION: 

Technology description follows: 

Pre-Biotic Formulation of Topical 

Chemicals for Use on Human Skin 

Description of Technology: Atopic 

dermatitis (AD) is a common, recurrent, 

chronic inflammatory skin disease that 

is a cause of considerable economic and 

social burden. It is one of the most 

prevalent skin disorders, affecting ∼25% 

of children in developed and 

developing countries and is expected to 

continue to escalate. This increased rate 

of incidence has changed the focus of 

research on AD toward epidemiology, 

prevention, and treatment. 


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Federal Register / Vol. 86, No. 124 / Thursday, July 1, 2021 / Notices 35101 

Scientists at NIAID have developed 

novel topical formulations that promote 

the growth of health-associated strains 

of commensal bacteria and inhibit 

disease-associated bacteria, thereby 

enhancing skin health. 

This technology is available for 

licensing 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. 

Potential Commercial Applications: 

• Over-the-counter formulations—this 

invention could be readily 

incorporated into popular body 

lotions or other skincare products to 

make ‘‘enhanced’’/‘‘microbiomefriendly’’ versions that promote the 

growth of health associated bacterial 

Competitive Advantages: 

• Benign safety profile with multiple 

mechanisms of action 

• Proven enhancement of beneficial 

microbiota 

• Can be readily incorporated into 

existing products 

Development Stage: 

• Pre-clinical 

Inventors: Carlos Castillo and Ian 

Myles, MD, MPH, both of NIAID. 

Publications: Castillo, Carlos, et al. 

‘‘Assessing the effects of common 

topical exposures on skin bacteria 

associated with atopic dermatitis’’, Skin 

Health and Disease, 2021.05.07. 

Intellectual Property: HHS Reference 

No. E–100–2021–0; US provisional 

application No. 63/175,368 filed on 

April 15, 2021. 

Licensing Contact: To license this 

technology, please contact David Yang 

at 240–695–6406 or yangp3@

mail.nih.gov and reference E–100– 

2021–0. 

Collaborative Research Opportunity: 

The National Institute of Allergy and 

Infectious Diseases is seeking statements 

of capability or interest from parties 

interested in collaborative research to 

further develop, evaluate or 

commercialize this technology. For 

collaboration opportunities, please 

contact David Yang at 240–695–6406 or 

yangp3@mail.nih.gov. 

Dated: June 24, 2021. 

Surekha Vathyam, 

Deputy Director, Technology Transfer and 

Intellectual Property Office, National Institute 

of Allergy and Infectious Diseases. 

[FR Doc. 2021–14129 Filed 6–30–21; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of Exclusive 

License, Inter-Institutional AgreementInstitution Lead: Biomarkers and 

Immunogenic Compositions for Filarial 

Parasites 

AGENCY: National Institutes of Health, 

National Institute of Allergy and 

Infectious Diseases, HHS. 

ACTION: Notice. 

SUMMARY: The National Institute of 

Allergy and Infectious Diseases, an 

institute of the National Institutes of 

Health, Department of Health and 

Human Services, is contemplating the 

grant of an exclusive, sublicensable 

patent license to New York Blood 

Center, Inc. (‘‘NYBC’’), located in New 

York, New York, in its rights to the 

technologies and patent applications 

listed in the SUPPLEMENTARY

INFORMATION section of this notice. 

DATES: Only written comments and/or 

applications for a license which are 

received by the Technology Transfer 

and Intellectual Property Office, 

National Institute of Allergy and 

Infectious Diseases, on or before July 16, 

2021 will be considered. 

ADDRESSES: Requests for copies of the 

patent applications, inquiries, and 

comments relating to the contemplated 

Exclusive License should be directed to: 

Theodoric Mattes, Ph.D., Technology 

Transfer and Patent Specialist, 

Technology Transfer and Intellectual 

Property Office, National Institute of 

Allergy and Infectious Diseases, 5601 

Fishers Lane, Suite 6D, MSC9804, 

Rockville, MD 20852–9804, phone 

number 240–627–3827, or 

theodoric.mattes@nih.gov. 

SUPPLEMENTARY INFORMATION: The 

following and all continuing U.S. 

patents/patent applications thereof are 

the intellectual properties to be licensed 

under the prospective agreement to 

NYBC: United States Provisional Patent 

Application Number 62/317,342, filed 

May 1, 2016, the title of which is 

‘‘Biomarkers and Immunogenic 

Compositions for Filarial Parasites’’ 

(HHS Reference No. E–288–2016–0–US– 

01); PCT Patent Application Number 

PCT/US2017/025554, filed March 31, 

2017, the title of which is ‘‘Biomarkers 

and Immunogenic Compositions for 

Filarial Parasites’’ (HHS Reference No. 

E–288–2016–00–PCT–02); United States 

Patent Application Number 16/090,013, 

filed September 28, 2018, the title of 

which is ‘‘Biomarkers and Immunogenic 

Compositions for Filarial Parasites’’ 

(HHS Reference No. E–288–2016–0–US– 

03); and United States Patent 

Application Number 17/076,616, filed 

October 21, 2020, the title of which is 

‘‘Biomarkers and Immunogenic 

Compositions for Filarial Parasites’’ 

(HHS Reference No. E–288–2016–0–US– 

04). 

The patent rights to this technology 

have been assigned to New York Blood 

Center, Inc. and the Government of the 

United States of America as represented 

by the Secretary, Department of Health 

& Human Services, by each institution’s 

respective inventors. 

The prospective patent license will be 

for the purpose of consolidating the 

patent rights to New York Blood Center, 

Inc., for the development and 

commercialization of the technology. 

Consolidation of these co-owned 

rights is intended to expedite 

development of the technology, 

consistent with the goals of the BayhDole Act codified as 35 U.S.C. 200–212. 

The prospective interinstitutional 

agreement may include an exclusive 

license for NIAID’s rights in these 

jointly owned patents. It will be 

sublicensable, and any sublicenses 

granted by NYBC will be subject to the 

provisions of 37 CFR part 404. NIAID 

will retain its rights to non-exclusively 

license its rights to the patent 

applications to third parties for internal 

research use. 

In the subject technology, researchers 

at NIAID and NYBC isolated and 

analyzed the transcriptome and 

proteome of the parasite at various life 

stages as well as its Wolbachia sp. 

endosymbiont to identify potential 

biomarkers for diagnostic assays and 

vaccine candidates. In all, they 

identified forty-seven (47) biomarkers. 

The associated patents claim the use of 

two or more of these biomarkers in 

conjunction with an adjuvant as an 

immunological composition, or the 

detection of any of these biomarkers in 

a serological-type assay. 

This notice is made in accordance 

with 35 U.S.C. 209 and 37 CFR part 404. 

The prospective exclusive license will 

be royalty bearing, and may be granted 

unless within fifteen (15) days from the 

date of this published notice the 

National Institute of Allergy and 

Infectious Diseases receives written 

evidence and argument that establishes 

that the grant of the license would not 

be consistent with the requirements of 

35 U.S.C. 209 and 37 CFR part 404. 

In response to this Notice, the public 

may file comments or objections. 

Comments and objections, other than 

those in the form of a license 

application, will not be treated 


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