43026 Federal Register / Vol. 82, No. 176 / Wednesday, September 13, 2017 / Notices 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2017–D–5297 for ‘‘Microdose 

Radiopharmaceutical Diagnostic Drugs: 

Nonclinical Study Recommendations; 

Draft Guidance for Industry; 

Availability.’’ Received comments will 

be placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). Submit written requests 

for single copies of the draft guidance to 

the Division of Drug Information, Center 

for Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Adebayo Laniyonu, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 5400, 

Silver Spring, MD 20993–0002, 301– 

796–1392. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Microdose Radiopharmaceutical 

Diagnostic Drugs: Nonclinical Study 

Recommendations.’’ This draft guidance 

is intended to assist developers of 

microdose radiopharmaceutical 

diagnostic drugs on the nonclinical 

studies recommended to support human 

clinical trials and marketing 

authorization. The draft guidance 

discusses how to refine nonclinical 

study recommendations for this class of 

drug given its unique characteristics. 

This draft guidance is intended to 

provide recommendations for a pathway 

to full drug development (marketing 

authorization) for microdose 

radiopharmaceutical diagnostic drugs. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on nonclinical studies recommended for 

microdose radiopharmaceutical 

diagnostic drugs. It does not establish 

any rights for any person and is not 

binding on FDA or the public. You can 

use an alternative approach if it satisfies 

the requirements of the applicable 

statutes and regulations. This guidance 

is not subject to Executive Order 12866. 

II. The Paperwork Reduction Act of 

1995 

This guidance refers to previously 

approved collections of information that 

are subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in 21 CFR parts 312 and 

314 have been approved under OMB 

control numbers 0910–0014 and 0910– 

0001, respectively. The collection of 

information for radioactive drug 

research committees in 21 CFR 361.1 

has been approved under OMB control 

number 0910–0053. The collection of 

information for the regulations on in 

vivo radiopharmaceuticals used for 

diagnosis and monitoring in 21 CFR 

315.4, 315.5, and 315.6 has been 

approved under OMB control number 

0910–0409. 

II. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm or https://

www.regulations.gov. 

Dated: September 7, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–19435 Filed 9–12–17; 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, 

Department of Health and Human 

Services. 

ACTION: Notice. 

SUMMARY: Government owned 

intellectual property covering HIV-1 

reverse transcriptase inhibitors available 

for licensing and commercialization. 

FOR FURTHER INFORMATION CONTACT: 

Licensing information and copies of the 

patent applications listed below may be 

obtained by emailing the indicated 

licensing contact at the National Heart, 

Lung, and Blood, Office of Technology 

Transfer and Development Office of 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 82, No. 176 / Wednesday, September 13, 2017 / Notices 43027 

Technology Transfer, 31 Center Drive 

Room 4A29, MSC2479, Bethesda, MD 

20892–2479; telephone: 301–402–5579. 

A signed Confidential Disclosure 

Agreement may be required to receive 

copies of the patent applications. 

SUPPLEMENTARY INFORMATION: The 

inventions listed below are owned by an 

agency of the U.S. Government and are 

available for licensing in the U.S. in 

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

CFR part 404 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. A description of the 

technology available for licensing 

follows. 

Pyrophosphate Analog HIV-1 Reverse 

Transcriptase Inhibitors 

Description of Technology: The 

invention relates to compounds that 

inhibit HIV-1 DNA synthesis mediated 

by reverse transcriptase (RT). HIV-1 

DNA synthesis by RT utilizes 

deoxynucleoside 5′-triphosphate (dNTP) 

as substrate and like many other 

enzymes, the reaction is reversible. 

Pyrophosphate analogs like 

imidodiphosphate strongly promote 

reverse reaction dNTP products 

containing the imidodiphosphate group 

instead of the naturally occurring 

pyrophosphate group. This 

imidodiphosphate-containing dNTP was 

found to be a potent inhibitor of the 

forward RT reaction. Whereas 

pyrophosphorolysis is limited by a 

nonchemical step, replacing the 

bridging oxygen of pyrophosphate with 

an imido group resulted in a change in 

the rate-limiting step, so that the 

imidodiphosphate-dependent reverse 

reaction was limited by chemistry. 

There exists, then, the potential to use 

pyrophosphate analogs therapeutically. 

Potential Commercial Applications: 

• Anti-microbial. 

• HIV therapeutic. 

Development Stage: 

• In vitro data available. 

Inventors: Samuel Wilson, William 

Beard, David Dion Shock (all of NIEHS). 

Intellectual Property: HHS Reference 

No. E–210–2017/0–US–01. 

• U.S. Provisional Patent Application 

62/542,600 filed August 8, 2017. 

Licensing Contact: Michael 

Shmilovich, Esq, CLP; 301–435–5019; 

shmilovm@nih.gov. 

Collaborative Research Opportunity: 

The National Institute of Environmental 

Health Sciences seeks statements of 

capability or interest from parties 

interested in collaborative research to 

further develop and evaluate, please 

contact Sally E. Tilotta, Ph.D., Director, 

Office of Technology Transfer, National 

Institute of Environmental Health 

Sciences, Phone: (919) 316–4526; 

sally.tilotta@nih.gov. 

Dated: September 7, 2017. 

Michael Shmilovich, 

Senior Licensing and Patenting Manager, 

National Heart, Lung, and Blood Institute, 

Office of Technology Transfer and 

Development. 

[FR Doc. 2017–19315 Filed 9–12–17; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel Shared 

Instruments: NMR spectrometers and X-ray 

crystallography/scattering. 

Date: October 3, 2017. 

Time: 11:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: David R Jollie, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4150, 

MSC 7806, Bethesda, MD 20892, (301) 435– 

1722, jollieda@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel Shared 

Instruments: NMR spectrometers and X-ray 

crystallography/scattering. 

Date: October 3, 2017. 

Time: 3:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: James W Mack, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4154, 

MSC 7806, Bethesda, MD 20892, (301) 435– 

2037, mackj2@csr.nih.gov. 

Name of Committee: Healthcare Delivery 

and Methodologies Integrated Review Group 

Community Influences on Health Behavior 

Study Section. 

Date: October 4–5, 2017. 

Time: 8:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Washington Plaza Hotel, 10 Thomas 

Circle, NW., Washington, DC 20005. 

Contact Person: Tasmeen Weik, DRPH, 

MPH, Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3141, 

Bethesda, MD 20892, 301–827–6480, weikts@

mail.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel Lymphatics 

in Health and Disease in the Digestive 

System, Kidney and Urinary Tract. 

Date: October 4, 2017. 

Time: 2:00 p.m. to 3:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Jianxin Hu, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 2156, 

Bethesda, MD 20892, 301–827–4417, 

jianxinh@csr.nih.gov. 

Name of Committee: Molecular, Cellular 

and Developmental Neuroscience Integrated 

Review Group Neurogenesis and Cell Fate 

Study Section. 

Date: October 5, 2017. 

Time: 8:00 a.m. to 6:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hyatt Regency Crystal City, 2799 

Jefferson Davis Highway, Arlington, VA 

22202. 

Contact Person: Joanne T Fujii, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4184, 

MSC 7850, Bethesda, MD 20892, (301) 435– 

1178, fujiij@csr.nih.gov. 

Name of Committee: Oncology 2— 

Translational Clinical Integrated Review 

Group Developmental Therapeutics Study 

Section. 

Date: October 5–6, 2017. 

Time: 8:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Embassy Suites Alexandria Old 

Town, 1900 Diagonal Road, Alexandria, VA 

22314. 

Contact Person: Sharon K Gubanich, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6214, 

MSC 7804, Bethesda, MD 20892, (301) 408– 

9512, gubanics@csr.nih.gov. 

Name of Committee: Interdisciplinary 

Molecular Sciences and Training Integrated 

Review Group Enabling Bioanalytical and 

Imaging Technologies Study Section. 

Date: October 5–6, 2017. 


sradovich on DSK3GMQ082PROD with NOTICES