Federal Register / Vol. 83, No. 140 / Friday, July 20, 2018 / Notices 34599 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002; or Office of Communication, 

Outreach and Development, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

3128, Silver Spring, MD 20993–0002. 

Send one self-addressed adhesive label 

to assist the office in processing your 

requests. The draft guidance may also be 

obtained by mail by calling CBER at 1– 

800–835–4709 or 240–402–8010. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Richard Lostritto, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 4132, 

Silver Spring, MD 20993, 301–796– 

1697, Richard.Lostritto@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of April 19, 

2018 (83 FR 17420), FDA announced the 

availability of a draft guidance for 

industry entitled ‘‘Metered Dose Inhaler 

and Dry Powder Inhaler Drug 

Products—Quality Considerations; Draft 

Guidance for Industry.’’ Interested 

persons were originally given until June 

18, 2018, to comment on the draft 

guidance. The Agency believes that 

reopening the comment period for an 

additional 60 days from the date of 

publication of this notice will allow 

adequate time for interested persons to 

submit comments without significantly 

delaying Agency decision making on 

these important issues. 

II. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm, https://

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/default.htm, or https://

www.regulations.gov. 

Dated: July 16, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–15508 Filed 7–19–18; 8:45 am] 

BILLING CODE 4164–01–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 inventions listed below 

are owned by an agency of the U.S. 

Government and are 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: 

Chris Kornak, 240–627–3705, 

chris.kornak@nih.gov. Licensing 

information and copies of the U.S. 

patent applications listed below may be 

obtained by communicating with the 

indicated licensing contact at the 

Technology Transfer and Intellectual 

Property Office (TTIPO), 5601 Fishers 

Lane, Suite 6D, MSC 9804, Rockville, 

MD 20892, tel: 301–496–2644, fax: 240– 

627–3117. A signed Confidential 

Disclosure Agreement will be required 

to receive copies of unpublished patent 

applications. 

SUPPLEMENTARY INFORMATION: 

Technology description follows. 

Inhibition of CD300f Function on 

Dendritic Cells Promotes Tumor 

Destruction 

Description of Technology: Cancer 

immunotherapy aims to enhance the 

ability of a patient’s own immune 

response to destroy tumors. The 

magnitude of the immune response is 

determined by the balance between 

immune activating signals and negative 

inhibitory signals. Checkpoint receptors 

are negative regulators that normally 

deliver inhibitory signals which limit 

immune activation. Blockade of 

immune checkpoints represents an 

effective strategy to enhance the 

immune response against cancer cells. 

NIAID researchers have discovered 

that blocking CD300f function in 

dendritic cells markedly enhances their 

ability to phagocytose and process 

apoptotic tumor cells, leading to 

substantial inhibition of tumor growth. 

In this light, CD300f may be viewed as 

a dendritic cell checkpoint receptor 

analogous to T cell checkpoint receptors 

like PD–1 and CTLA–4. As a result, 

inhibiting CD300f function on dendritic 

cells could be a promising anti-cancer 

therapy, especially in the settings where 

blocking of T cell checkpoint receptors 

has been ineffective. 

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: 

• Cancer immunotherapy 

Competitive Advantages: 

• A novel approach 

Development Stage: 

• Pre-Clinical 

• Proof-of-concept studies in mouse 

models 

Inventors: John E. Coligan, Konrad 

Krzewski, Linjie Tian, Ha-Na Lee, all of 

NIAID, NIH. 

Publications: Tian, L. et al., Enhanced 

efferocytosis by dendritic cells underlies 

memory T-cell expansion and 

susceptibility to autoimmune disease in 

CD300f-deficient mice. Cell Death and 

Differ (2016) 23, 1086–1096. 

Intellectual Property: HHS Reference 

No. E–257–2016/0—U.S. Patent 

Application No. 62/408,596 filed on 10/ 

14/2016;—PCT/US2017/056192 filed on 

10/11/2017. 

Licensing Contact: Chris Kornak, 240– 

627–3705, Chris.Kornak@nih.gov. 

Collaborative Research Opportunity: 

The Technology Transfer and 

Intellectual Property Office (TTIPO) is 

not seeking parties interested in 

collaborative research to further develop 

the technology. 

Dated: July 9, 2018. 

Suzanne M. Frisbie, 

Deputy Director, Technology Transfer and 

Intellectual Property Office, National Institute 

of Allergy and Infectious Diseases. 

[FR Doc. 2018–15489 Filed 7–19–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; 60-Day Comment 

Request; Generic Clearance To 

Conduct Voluntary Customer/Partner 

Surveys (NLM) 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995 to provide 

opportunity for public comment on 

proposed data collection projects, the 


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