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

with one another and to select a 

candidate, within 60 days after the 

receipt of the FDA letter, to serve as the 

nonvoting member to represent industry 

interests for a particular device panel. 

The interested organizations are not 

bound by the list of nominees in 

selecting a candidate. However, if no 

individual is selected within 60 days, 

the Commissioner will select the 

nonvoting member to represent industry 

interests. 

IV. Application Procedure 

Individuals may self-nominate and/or 

an organization may nominate one or 

more individuals to serve as a nonvoting 

industry representative. Nomination 

must include a current, complete 

re ́sume ́ or curriculum vitae for each 

nominee including current business 

address and telephone number, email 

address if available, and a signed copy 

of the Acknowledgement and Consent 

form available at the FDA Advisory 

Committee Membership Nomination 

Portal (see ADDRESSES) within 30 days of 

publication of this document (see 

DATES). Nominations must also specify 

the advisory panel for which the 

nominee is recommended. Nominations 

must also acknowledge that the 

nominee is aware of the nomination 

unless self-nominated. FDA will 

forward all nominations to the 

organizations expressing interest in 

participating in the selection process for 

the particular device panels listed in the 

table. (Persons who nominate 

themselves as nonvoting industry 

representatives will not participate in 

the selection process). 

FDA seeks to include the views of 

women and men, members of all racial 

and ethnic groups, and individuals with 

and without disabilities on its advisory 

committees and, therefore encourages 

nominations of appropriately qualified 

candidates from these groups. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to advisory committees. 

Dated: December 27, 2021. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2021–28453 Filed 12–30–21; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

Statement of Organization, Functions, 

and Delegations of Authority 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration’s (FDA), Office of the 

Commissioner (OC), Office of the Chief 

Scientist (OCS) has modified their 

organizational structure. The new 

organizational structure was approved 

by the Deputy Secretary of Health and 

Human Services and effective on 

November 24, 2021. 

FOR FURTHER INFORMATION CONTACT: 

Yashika Rahaman, Director, Office of 

Planning, Evaluation and Risk 

Management, Office of Finance, Budget, 

Acquisitions and Planning, FDA, 4041 

Powder Mill Road, Beltsville, MD 

20705–4304, 301–796–3843. 

I. Introduction 

Part D, Chapter D–B, (Food and Drug 

Administration), the Statement of 

Organization, Functions and 

Delegations of Authority for the 

Department of Health and Human 

Services (35 FR 3685, February 25, 

1970, 60 FR 56606, November 9, 1995, 

64 FR 36361, July 6, 1999, 72 FR 50112, 

August 30, 2007, 74 FR 41713, August 

18, 2009, 76 FR 45270, July 28, 2011, 

and 84 FR 22854, May 20, 2019) is 

revised to reflect the Food and Drug 

Administration’s reorganization of 

Office of the Chief Scientist. 

The FDA Office of the Commissioner, 

Office of the Chief Scientist (OCS), is 

realigning the FDA Technology Transfer 

Program (FDATT), from the Office of 

Regulatory Science and Innovation 

(ORSI), OCS, to the OCS Immediate 

Office (OCS–IO). This realignment of 

the FDATT program and resources 

intends to further enhance the 

effectiveness of FDA’s partnership 

programs by increasing the FDA-wide 

its efforts to (1) facilitate the 

implementation of authorizing 

legislation for federal technology 

transfer, (2) ensure compliance with 

relevant legal and regulatory 

requirements, and (3) establish/maintain 

related policies and processes. The 

realignment will also increase OCS’s 

effectiveness in driving regulatory 

science research through external 

partnerships and would demonstrate 

FDA’s commitment to strengthening its 

partnership and collaboration 

capabilities, which are key contributors 

to sustaining FDA’s ability to see and be 

at the forefront of biomedical 

advancements in carrying out its public 

health mission. Additionally, OCS is 

abolishing the Division of Science 

Innovation & Critical Path from its 

Office of Regulatory Science and 

Innovation (ORSI). ORSI’s programs 

have evolved away from the need for 

this division. This proposed, formal 

abolishment of the division will serve as 

a corrective action to align ORSI’s 

organizational structure with its current 

programmatic responsibilities that fulfill 

its functions. The Food and Drug 

Administration’s Office of the Chief 

Scientist has been restructured as 

follows: 

DCCF. ORGANIZATION. The Office 

of the Chief Scientist is headed by the 

FDA Chief Scientist, and includes the 

following: 

Office of the Chief Scientist (DCP) 

Advisory Committee Oversight and 

Management Staff (DCP1) 

FDA Technology Transfer Program Staff 

(DCP2) 

Office of Counter-Terrorism and 

Emerging Threats (DCPA) 

Office of Laboratory Safety (DCPB) 

Office of Regulatory Science and 

Innovation (DCPC) 

Office of Scientific Integrity (DCPD) 

Office of Scientific Professional 

Development (DCPE) 

National Center for Toxicological 

Research (DCPF) 

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/Reports

ManualsForms/StaffManualGuides/ 

default.htm. 

Authority: 44 U.S.C. 3101. 

Dated: October 22, 2021. 

Andrea Palm, 

Deputy Secretary of Health and Human 

Services. 

[FR Doc. 2021–28385 Filed 12–30–21; 8:45 am] 

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