35662 Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices 

the party to whom FDA will send the 

invoice for any fees that are assessed 

under this section. 

C. How much will this fee be? 

The fee is based on the number of 

direct hours spent on such 

reinspections, including time spent 

conducting the physical surveillance 

and/or compliance reinspection at the 

facility, or whatever components of 

such an inspection are deemed 

necessary, making preparations and 

arrangements for the reinspection, 

traveling to and from the facility, 

preparing any reports, analyzing any 

samples or examining any labels if 

required, and performing other activities 

as part of the OAI reinspection until the 

facility is again determined to be in 

compliance. The direct hours spent on 

each such reinspection will be billed at 

the appropriate hourly rate shown in 

table 2 of this document. 

IV. Fees for Non-Compliance With a 

Recall Order Under Section 743(a)(1)(B) 

A. What will cause this fee to be 

assessed? 

The fee will be assessed for not 

complying with a recall order under 

section 423(d) (21 U.S.C. 350l(d)) or 

section 412(f) of the FD&C Act (21 

U.S.C. 350a(f)) to cover food recall 

activities associated with such order 

performed by the Secretary (and by 

delegation, FDA) (section 743(a)(1)(B) of 

the FD&C Act). Non-compliance may 

include the following: (1) Not initiating 

a recall as ordered by FDA; (2) not 

conducting the recall in the manner 

specified by FDA in the recall order; or 

(3) not providing FDA with requested 

information regarding the recall, as 

ordered by FDA. 

B. Who will be responsible for paying 

this fee? 

Section 743(a)(1)(B) of the FD&C Act 

states that the fee is to be paid by the 

responsible party for a domestic facility 

(as defined in section 415(b) of the 

FD&C Act) and an importer who does 

not comply with a recall order under 

section 423 or under section 412(f) of 

the FD&C Act. In other words, the party 

paying the fee would be the party that 

received the recall order. 

C. How much will this fee be? 

The fee is based on the number of 

direct hours spent on taking action in 

response to the firm’s failure to comply 

with a recall order. Types of activities 

could include conducting recall audit 

checks, reviewing periodic status 

reports, analyzing the status reports and 

the results of the audit checks, 

conducting inspections, traveling to and 

from locations, and monitoring product 

disposition. The direct hours spent on 

each such recall will be billed at the 

appropriate hourly rate shown in table 

2 of this document. 

V. How must the fees be paid? 

An invoice will be sent to the 

responsible party for paying the fee after 

FDA completes the work on which the 

invoice is based. Payment must be made 

within 90 days of the invoice date in 

U.S. currency by check, bank draft, or 

U.S. postal money order payable to the 

order of the Food and Drug 

Administration. Detailed payment 

information will be included with the 

invoice when it is issued. 

VI. What are the consequences of not 

paying these fees? 

Under section 743(e)(2) of the FD&C 

Act, any fee that is not paid within 30 

days after it is due shall be treated as a 

claim of the U.S. Government subject to 

provisions of subchapter II of chapter 37 

of title 31, United States Code. 

Dated: July 24, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–16069 Filed 7–26–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meeting of the President’s Council on 

Sports, Fitness, and Nutrition 

AGENCY: President’s Council on Sports, 

Fitness, and Nutrition, Office of the 

Assistant Secretary for Health, Office of 

the Secretary, Department of Health and 

Human Services. 

ACTION: Notice of meeting. 

SUMMARY: As stipulated by the Federal 

Advisory Committee Act, the U.S. 

Department of Health and Human 

Services (HHS) is hereby giving notice 

that the President’s Council on Sports, 

Fitness, and Nutrition (PCSFN) will 

hold its annual meeting. The meeting 

will be open to the public. 

DATES: The meeting will be held on 

September 21, 2018, from 9:30 a.m. to 

12:30 p.m. 

ADDRESSES: Newseum, Knight 

Conference Center 7th Floor, 555 

Pennsylvania Ave. NW, Washington, DC 

20001. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Holli M. Richmond, Executive Director, 

Office of the President’s Council on 

Sports, Fitness, and Nutrition, Tower 

Building, 1101 Wootton Parkway, Suite 

560, Rockville, MD 20852, (240) 276– 

9567. Information about PCSFN, 

including details about the upcoming 

meeting, can be obtained at 

www.fitness.gov. 

SUPPLEMENTARY INFORMATION: The 

primary functions of the PCSFN include 

(1) advising the President, through the 

Secretary, concerning progress made in 

carrying out the provisions of Executive 

Order 13265, as amended by Executive 

Order 13824, and recommending to the 

President, through the Secretary, actions 

to accelerate such progress; (2) 

recommending to the Secretary a 

national strategy to expand children’s 

participation in youth sports, encourage 

regular physical activity, including 

active play and promote good nutrition 

for all Americans. Recommendations 

may address, but are not necessarily 

limited to, increasing awareness of the 

benefits of participation in sports and 

regular physical activity, as well as the 

importance of good nutrition; promoting 

private and public sector strategies to 

increase participation in sports, 

encourage regular physical activity, and 

improve nutrition; developing metrics 

that gauge youth sports participation 

and physical activity to inform efforts 

that will improve participation in sports 

and regular physical activity among 

young Americans; and establishing a 

national and local strategy to recruit 

volunteers who will encourage and 

support youth participation in sports 

and regular physical activity, through 

coaching, mentoring, teaching, or 

administering athletic and nutritional 

programs. The Council’s performance of 

these functions shall take into account 

the Department of Health and Human 

Services’ Physical Activity Guidelines 

for Americans, including consideration 

for youth with disabilities. 

The Council shall meet, at a 

minimum, one time per fiscal year. The 

meeting will be held to (1) assess 

ongoing Council activities; and, (2) 

discuss and plan future projects and 

programs. The agenda for the planned 

meeting is being developed and will be 

posted at www.fitness.gov when it has 

been finalized. 

The meeting that is scheduled to be 

held on September 21, 2018, is open to 

the public and the media. Every effort 

will be made to provide reasonable 

accommodations for persons with 

disabilities and/or special needs who 

wish to attend the meeting. Persons 

with disabilities and/or special needs 

should call (240) 276–9567 no later than 

close of business Monday, September 

10, 2018, to request accommodations. 

Members of the public who wish to 

attend the meeting are asked to preregister by sending an email to 


amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices 35663 

rsvp.fitness@hhs.gov or by calling (240) 

276–9567. Registration for public 

attendance must be completed before 

close of business Wednesday, 

September 12, 2018. 

Dated: July 12, 2018. 

Holli M. Richmond, 

Executive Director, Office of the President’s 

Council on Sports, Fitness, and Nutrition, 

U.S. Department of Health and Human 

Services. 

[FR Doc. 2018–16056 Filed 7–26–18; 8:45 am] 

BILLING CODE 4150–35–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Prospective Grant of Exclusive Patent 

License: Radiotherapeutics Against 

Somatostatin-Receptor Expressing 

Neuroendocrine Tumors 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The National Heart, Lung and 

Blood Institute (NHLBI), National 

Institutes of Health, Department of 

Health and Human Services, is 

contemplating the grant of an exclusive 

patent license to Molecular Targeting 

Technologies, Inc. (MTTI); a Delaware 

corporation, with its principle place of 

business in West Chester, Pennsylvania, 

to practice the inventions embodied in 

the patent application listed in the 

SUPPLEMENTARY INFORMATION section of 

this notice. 

DATES: Only written comments and/or 

applications for a license which are 

received by the NHLBI Office of 

Technology Transfer and Development 

August 27, 2018 will be considered. 

ADDRESSES: Requests for copies of the 

patent applications, inquiries, and 

comments relating to the contemplated 

exclusive patent license should be 

directed to: Michael Shmilovich, Esq., 

Senior Licensing and Patent Manager, 

31 Center Drive, Room 4A29, MSC2479, 

Bethesda, MD 20892–2479, phone 

number 301–435–5019, or shmilovm@

mail.nih.gov. 

SUPPLEMENTARY INFORMATION: The 

following and all continuing U.S. and 

foreign patents/patent applications 

thereof are the intellectual properties to 

be licensed under the prospective 

agreement to MTTI: HHS Ref. E–150– 

2016–1–PCT–01, International Patent 

Application PCT/US2017/054863 filed 

October 3, 2017, entitled ‘‘Chemical 

Conjugates of Evans Blue Derivatives 

and Their Use As Radiotherapy And 

Imaging Agents.’’ 

The patent rights in these inventions 

have been assigned to the Government 

of the United States of America. The 

prospective patent license will be 

granted worldwide and in a field of use 

not broader than radiotherapeutics for 

somatostatin-receptor expressing 

neuroendocrine tumors. 

The invention pertains to a 

radiotherapeutic against neuroendocrine 

tumors that express somatostatin 

receptor. Radionuclide therapies 

directed against tumors that express 

somatostatin receptors (SSTRs) have 

proven effective for the treatment of 

advanced, low- to intermediate-grade 

neuroendocrine tumors. The subject 

radiotherapeutic covered by the subject 

patent estate includes a somatostatin 

(SST) peptide derivative like octreotate 

(TATE), conjugated to an Evans Blue 

(EB) analog, and further chelated via 

DOTA to therapeutic radionuclide 

177Lu, a beta emitter. The EB analog 

reversibly binds to circulating serum 

albumin and improves the 

pharmacokinetics of SST peptide 

derivatives and reduce peptide-receptor 

radionuclide therapy toxicity. EB analog 

conjugated to octreotate (EBDOTATATE) has been shown by the 

inventors to provide reversible albumin 

binding in vivo and extended half-life in 

circulation. When EB-TATE is slowly 

released into the tumor 

microenvironment, tumor uptake and 

internalization into SSTR positive 

tumors resulted in delivery of 

radioactive particles and tumor cell 

killing. EB-TATE displayed significantly 

more favorable pharmacokinetics than 

TATE alone by achieving higher tumor 

to non-tumor penetration as evidenced 

by positron emission tomography. 

This notice is made in accordance 

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

The prospective exclusive patent license 

will be royalty bearing and may be 

granted unless within fifteen (15) days 

from the date of this published notice, 

the NHLBI 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. 

Complete applications for a license in 

the prospective field of use that are 

timely filed in response to this notice 

will be treated as objections to the grant 

of the contemplated exclusive patent 

license. 

Comments and objections submitted 

to this notice will not be made available 

for public inspection and, to the extent 

permitted by law, will not be released 

under the Freedom of Information Act, 

5 U.S.C. 552. 

Dated: July 20, 2018. 

Michael A. Shmilovich, 

Senior Licensing and Patenting Manager, 

National Heart, Lung, and Blood Institute, 

Office of Technology Transfer and 

Development. 

[FR Doc. 2018–16065 Filed 7–26–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; 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 grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; U01 SEP: 

Glycobiologists Alliance for Cancer Research. 

Date: August 30, 2018. 

Time: 10:00 a.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Cancer Institute, Shady 

Grove, 9609 Medical Center Drive, Room 

7W102, Rockville, MD 20850 (Telephone 

Conference Call). 

Contact Person: Shakeel Ahmad, Ph.D., 

Scientific Review Officer, Research 

Technology and Contract Review Branch, 

Division of Extramural Activities, National 

Cancer Institute, NIH, 9609 Medical Center 

Drive, Room 7W102, Bethesda, MD 20892– 

9750, 240–276–6349, ahmads@mail.nih.gov. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel; NCI 

Program Project IV (P01). 

Date: September 27–28, 2018. 

Time: 4:00 p.m. to 5:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda North Marriott Hotel & 

Conference Center, 5701 Marinelli Road, 

North Bethesda, MD 20852. 

Contact Person: Sanita Bharti, Ph.D., 

Scientific Review Officer, Research Program 

Review Branch, Division of Extramural 

Activities, National Cancer Institute, NIH, 

9609 Medical Center Drive, Room 7W122, 

Bethesda, MD 20892–9750, 240–276–5909, 

sanitab@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 


amozie on DSK3GDR082PROD with NOTICES1