92 Federal Register / Vol. 87, No. 1 / Monday, January 3, 2022 / Notices 

Division of Health Technology V B 

(DCCFGB) 

Office of Health Technology VI (DCCFH) 

Division of Health Technology VI A 

(DCCFHA) 

Division of Health Technology VI B 

(DCCFHB) 

Division of Health Technology VI C 

(DCCFHC) 

Office of Health Technology VII (DCCFI) 

Division of Chemistry and Toxicology 

(DCCFIA) 

Division of Immunology and 

Hematology (DCCFIB) 

Division of Microbiology (DCCFIC) 

Division of Program Management and 

Operations (DCCFIE) 

Division of Molecular Genetics and 

Pathology (DCCFIG) 

Office of Health Technology VIII 

(DCCFJ) 

Division of Health Technology VIII A 

(DCCFJA) 

Division of Health Technology VIII B 

(DCCFJB) 

Division of Health Technology VIII C 

(DCCFJC) 

DCFF. Organization. The Center for 

tobacco Product’s Office of Compliance 

and Enforcement is headed by the 

Director, Office of Compliance and 

Enforcement and includes the 

following: 

Division of Enforcement and 

Manufacturing (DCFFA) 

Division of Promotion, Advertising, and 

Labeling (DCFFB) 

Division of State Programs (DCFFC) 

Division of Business Operations 

(DCFFD) 

Division of External Programs and 

Resource Management (DCFFE) 

Division of Product Compliance 

(DCFFF) 

DCFD. Organization. The Center for 

tobacco Product’s Office of Science is 

headed by the Director, Office of 

Science and includes the following: 

Division of Regulatory Project 

Management (DCFDA) 

Division of Regulatory Science 

Informatics (DCFDB) 

Division of Product Science (DCFDC) 

Division of Individual Health Science 

(DCFDD) 

Division of Population Health Science 

(DCFDE) 

Division of Non-Clinical Sciences 

(DCFDF) 

Division of Research and Knowledge 

Integration (DCFDG) 

II. Delegations of Authority 

Pending further delegation, directives, 

or orders by the Commissioner of Food 

and Drugs, all delegations and 

redelegations of authority made to 

officials and employees of affected 

organizational components will 

continue in them or their successors 

pending further redelegations, provided 

they are consistent with this 

reorganization. 

III. Electronic Access 

This reorganization is reflected in 

FDA’s Staff Manual Guide (SMG). 

Persons interested in seeing the 

complete Staff Manual Guide can find it 

on FDA’s website at: https://

www.fda.gov/AboutFDA/ 

ReportsManualsForms/ 

StaffManualGuides/default.htm. 

Authority: 44 U.S.C. 3101. 

Dated: October 22, 2021. 

Andrea Palm, 

Deputy Secretary of Health and Human 

Services. 

[FR Doc. 2021–28386 Filed 12–30–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–1243] 

Prospective Grant of an Exclusive 

Patent License: A Diagnostic Tool 

Based Upon Magnetic Resonance 

Spectroscopy Pre-Processing and 

Renormalization 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is contemplating 

the grant of an Exclusive Patent License 

to practice the invention embodied in 

the U.S. Patent listed in the 

SUPPLEMENTARY INFORMATION section of 

this notice to Voxel Systems, LLC 

located in Houston, Texas. 

DATES: Only written comments and/or 

applications for a license that are 

received by FDA’s Technology Transfer 

Office on or before January 18, 2022, 

will be considered. 

ADDRESSES: Inquiries and comments 

relating to the contemplated Exclusive 

Patent License should be directed to: 

Ken Millburne, Food and Drug 

Administration Technology Transfer 

Office, Bldg. 1, Rm. 4213, Silver Spring, 

MD 20993, 240–478–1662; email: 

Kenneth.Millburne@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Intellectual Property 

FDA Reference No.: E–2009–011/US–04: 

‘‘System for Magnetic Resonance 

Spectroscopy of Brain Tissue for 

Pattern-Based Diagnostics’’ 

I. U.S. Non-Provisional Application 

13/509,539, filed November 12, 2010 

(FDA Reference No.: E–2009–011/US– 

04). 

II. U.S. Patent granted November 4, 

2014: U.S. Patent 8,880,354 B2 (FDA 

Reference No. E–2009–011/US–04). 

The patent rights in this invention 

have been assigned to the Government 

of the United States of America. 

The prospective exclusive license 

territory may be worldwide and in fields 

of use that may be limited to: (1) Any 

and all in vivo use, application, or 

developmental activity related to the 

software, processing algorithm, and 

Licensed Processes and Products; (2) all 

human and animal diagnostics, in preclinical, or clinical utilizations for any 

and all maladies; (3) all human research 

applications for expanded magnetic 

resonance imaging (MRI) utilization, 

application development, drug 

development tools, molecular 

compound characterization, algorithms, 

and biomarker identification and 

development; and (4) all animal or other 

research applications and translational 

studies for ultra high-field MRI 

investigations, drug development, 

metabolite, and biomarker 

identification. 

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. The prospective 

exclusive license may be granted unless, 

within 15 days from the date of this 

published notice, FDA 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 

confidentially, and may be made 

publicly available. 

License applications submitted in 

response to this notice will be presumed 

to contain business confidential 

information and any release of 

information in these license 

applications will be made only as 

required and upon a request under the 

Freedom of Information Act, 5 U.S.C. 

552. 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 1 / Monday, January 3, 2022 / Notices 93 

Dated December 27, 2021. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2021–28397 Filed 12–30–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0008] 

Request for Nominations on Public 

Advisory Panels of the Medical 

Devices Advisory Committee 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is requesting that 

any industry organizations interested in 

participating in the selection of 

nonvoting industry representatives to 

serve on certain panels of the Medical 

Devices Advisory Committee (MDAC or 

Committee) in the Center for Devices 

and Radiological Health (CDRH) notify 

FDA in writing. FDA is also requesting 

nominations for nonvoting industry 

representatives to serve on certain 

device panels of the MDAC in the 

CDRH. A nominee may either be selfnominated or nominated by an 

organization to serve as a nonvoting 

industry representative. Nominations 

will be accepted for current and 

upcoming vacancies effective with this 

notice. 

DATES: Any industry organization 

interested in participating in the 

selection of an appropriate nonvoting 

member to represent industry interests 

must send a letter stating that interest to 

the FDA by February 2, 2022 (see 

sections I and II of this document for 

further details). Concurrently, 

nomination materials for prospective 

candidates should be sent to FDA by 

February 2, 2022. 

ADDRESSES: All statements of interest 

from industry organizations interested 

in participating in the selection process 

of nonvoting industry representative 

nomination should be sent to Margaret 

Ames (see FOR FURTHER INFORMATION

CONTACT). All nominations for 

nonvoting industry representatives 

should be submitted electronically by 

accessing the FDA Advisory Committee 

Membership Nomination Portal: https:// 

www.accessdata.fda.gov/scripts/ 

FACTRSPortal/FACTRS/index.cfm or by 

mail to Advisory Committee Oversight 

and Management Staff, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5103, Silver Spring, 

MD 20993–0002. Information about 

becoming a member of an FDA advisory 

committee can also be obtained by 

visiting FDA’s website at https://

www.fda.gov/AdvisoryCommittees/ 

default.htm. 

FOR FURTHER INFORMATION CONTACT: 

Margaret Ames, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5213, Silver Spring, 

MD 20993, 301–796–5960, email: 

margaret.ames@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Agency is requesting nominations for 

nonvoting industry representatives to 

the panels listed in the table in this 

document. 

I. Medical Devices Advisory Committee 

The Committee reviews and evaluates 

data on the safety and effectiveness of 

marketed and investigational devices 

and makes recommendations for their 

regulation. The panels engage in a 

number of activities to fulfill the 

functions the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) envisions for 

device advisory panels. With the 

exception of the Medical Devices 

Dispute Resolution Panel, each panel, 

according to its specialty area, advises 

the Commissioner of Food and Drugs 

(the Commissioner) regarding 

recommended classification or 

reclassification of devices into one of 

three regulatory categories; advises on 

any possible risks to health associated 

with the use of devices; advises on 

formulation of product development 

protocols; reviews premarket approval 

applications for medical devices; 

reviews guidelines and guidance 

documents; recommends exemption of 

certain devices from the application of 

portions of the FD&C Act; advises on the 

necessity to ban a device; and responds 

to requests from the agency to review 

and make recommendations on specific 

issues or problems concerning the safety 

and effectiveness of devices. With the 

exception of the Medical Devices 

Dispute Resolution Panel, each panel, 

according to its specialty area, may also 

make appropriate recommendations to 

the Commissioner on issues relating to 

the design of clinical studies regarding 

the safety and effectiveness of marketed 

and investigational devices. The 

Committee also provides 

recommendations to the Commissioner 

or designee on complexity 

categorization of in vitro diagnostics 

under the Clinical Laboratory 

Improvement Amendments of 1988. 

Panels Function 

Circulatory System Devices Panel ..................................... Reviews and evaluate data concerning the safety and effectiveness of marketed and 

investigational devices for use in the circulatory and vascular systems and makes 

appropriate recommendations to the Commissioner of Food and Drugs. 

Obstetrics and Gynecology Devices Panel ....................... Reviews and evaluates data concerning the safety and effectiveness of marketed 

and investigational devices for use in obstetrics and gynecology and makes appropriate recommendations to the Commissioner of Food and Drugs. 

Radiological Devices Panel ............................................... Reviews and evaluates data concerning the safety and effectiveness of marketed 

and investigational diagnostic or therapeutic radiological and nuclear medicine devices and makes appropriate recommendations to the Commissioner of Food and 

Drugs. 

II. Qualifications 

Persons nominated for the device 

panels should be full-time employees of 

firms that manufacture products that 

would come before the panel, or 

consulting firms that represent 

manufacturers, or have similar 

appropriate ties to industry. 

III. Selection Procedure 

Any industry organization interested 

in participating in the selection of an 

appropriate nonvoting member to 

represent industry interests should send 

a letter stating that interest to the FDA 

contact (see FOR FURTHER INFORMATION

CONTACT) within 30 days of publication 

of this document (see DATES). Within the 

subsequent 30 days, FDA will send a 

letter to each organization that has 

expressed an interest, attaching a 

complete list of all such organizations; 

and a list of all nominees along with 

their current resumes. The letter will 

also state that it is the responsibility of 

the interested organizations to confer 


khammond on DSKJM1Z7X2PROD with NOTICES