Request for Nominations on Public Advisory Panels of the Medical Devices Advisory Committee, 65832-65833 [2020-22911]

Download as PDF 65832 Federal Register / Vol. 85, No. 201 / Friday, October 16, 2020 / Notices section 413(a) of the FD&C Act provides that the dietary supplement containing the NDI is deemed to be adulterated under section 402(f) of the FD&C Act (21 U.S.C. 342(f)). Even if the notification is submitted as required, the dietary supplement containing the NDI is adulterated under section 402(f) of the FD&C Act unless there is a history of use or other evidence of safety establishing that the NDI, when used under the conditions recommended or suggested in the labeling of the dietary supplement, will reasonably be expected to be safe. This requirement is separate from and additional to the requirement to submit a premarket notification for the NDI. FDA’s regulation on NDI notifications, § 190.6(a), requires the manufacturer or distributor of the dietary supplement or of the NDI to submit to FDA the information that forms the basis for its conclusion that a dietary supplement containing the NDI will reasonably be expected to be safe. Thus, § 190.6 only requires the manufacturer or distributor to extract and summarize information that should have already been developed to meet the safety requirement in section 413(a)(2) of the FD&C Act. Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate. Dated: October 9, 2020. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2020–22930 Filed 10–15–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–N–3179] Request for Nominations on Public Advisory Panels of the Medical Devices Advisory Committee AGENCY: Food and Drug Administration, HHS. jbell on DSKJLSW7X2PROD with NOTICES ACTION: Notice. 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 FDA by November 16, 2020 (see sections I and II of this document for further details). Concurrently, nomination materials for prospective candidates should be sent to FDA by November 16, 2020. 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 SUMMARY: Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5213, Silver Spring, MD 20993, 301–796–5960, email: margaret.ames@fda.hhs.gov. The Agency is requesting nominations for nonvoting industry representatives to the panels listed in the table in this document. SUPPLEMENTARY INFORMATION: 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 (the 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 Anesthesiology and Respiratory Therapy Devices Panel. Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational devices for use in anesthesiology and respiratory therapy and makes appropriate recommendations to the Commissioner. Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational products for use in dentistry, endodontics or bone physiology relative to the oral and maxillofacial area and makes appropriate recommendations to the Commissioner. Dental Products Panel (one representative—to represent the dental drug industry). VerDate Sep<11>2014 18:59 Oct 15, 2020 Jkt 253001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\16OCN1.SGM 16OCN1 Federal Register / Vol. 85, No. 201 / Friday, October 16, 2020 / Notices Panels Function Medical Devices Dispute Resolution Panel ........ Provides advice to the Center Director on complex or contested scientific issues between FDA and medical device sponsors, applicants, or manufacturers relating to specific products, marketing applications, regulatory decisions and actions by FDA, and Agency guidance and policies. Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational in vitro diagnostic devices for use in clinical laboratory medicine including microbiology, virology, and infectious disease and makes recommendations to the Commissioner. Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational in vitro devices for use in clinical laboratory medicine including clinical and molecular genetics and makes appropriate recommendations to the Commissioner. Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational devices for use in the neurological system and makes appropriate recommendations to the Commissioner. 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. Microbiology Devices Panel ............................... Molecular and Clinical Genetics Panel ............... Neurological Devices Panel ................................ Radiological Devices Panel ................................ 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 re´sume´s. The letter will also state that it is the responsibility of the interested organizations to confer 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. 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: October 9, 2020. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2020–22911 Filed 10–15–20; 8:45 am] BILLING CODE 4164–01–P IV. Application Procedure jbell on DSKJLSW7X2PROD with NOTICES 65833 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 VerDate Sep<11>2014 18:59 Oct 15, 2020 Jkt 253001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Comment Request Information Collection Request Title: Survey of Eligible Users of the National Practitioner Data Bank, OMB No. 0915– 0366—Reinstatement With Change Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice. AGENCY: In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR. DATES: Comments on this ICR should be received no later than December 15, 2020. ADDRESSES: Submit your comments to paperwork@hrsa.gov or mail the HRSA Information Collection Clearance Officer, Room 14N136B, 5600 Fishers Lane, Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call Lisa Wright-Solomon, the HRSA Information Collection Clearance Officer at (301) 443–1984. SUPPLEMENTARY INFORMATION: When submitting comments or requesting information, please include the SUMMARY: E:\FR\FM\16OCN1.SGM 16OCN1

Agencies

[Federal Register Volume 85, Number 201 (Friday, October 16, 2020)]
[Notices]
[Pages 65832-65833]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22911]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3179]


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 self-nominated 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 FDA by November 
16, 2020 (see sections I and II of this document for further details). 
Concurrently, nomination materials for prospective candidates should be 
sent to FDA by November 16, 2020.

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: 
[email protected].

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 (the 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
------------------------------------------------------------------------
Anesthesiology and             Reviews and evaluates data concerning the
 Respiratory Therapy Devices    safety and effectiveness of marketed and
 Panel.                         investigational devices for use in
                                anesthesiology and respiratory therapy
                                and makes appropriate recommendations to
                                the Commissioner.
Dental Products Panel (one     Reviews and evaluates data concerning the
 representative--to represent   safety and effectiveness of marketed and
 the dental drug industry).     investigational products for use in
                                dentistry, endodontics or bone
                                physiology relative to the oral and
                                maxillofacial area and makes appropriate
                                recommendations to the Commissioner.

[[Page 65833]]

 
Medical Devices Dispute        Provides advice to the Center Director on
 Resolution Panel.              complex or contested scientific issues
                                between FDA and medical device sponsors,
                                applicants, or manufacturers relating to
                                specific products, marketing
                                applications, regulatory decisions and
                                actions by FDA, and Agency guidance and
                                policies.
Microbiology Devices Panel...  Reviews and evaluates data concerning the
                                safety and effectiveness of marketed and
                                investigational in vitro diagnostic
                                devices for use in clinical laboratory
                                medicine including microbiology,
                                virology, and infectious disease and
                                makes recommendations to the
                                Commissioner.
Molecular and Clinical         Reviews and evaluates data concerning the
 Genetics Panel.                safety and effectiveness of marketed and
                                investigational in vitro devices for use
                                in clinical laboratory medicine
                                including clinical and molecular
                                genetics and makes appropriate
                                recommendations to the Commissioner.
Neurological Devices Panel...  Reviews and evaluates data concerning the
                                safety and effectiveness of marketed and
                                investigational devices for use in the
                                neurological system and makes
                                appropriate recommendations to the
                                Commissioner.
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.
------------------------------------------------------------------------

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 r[eacute]sum[eacute]s. The letter will also 
state that it is the responsibility of the interested organizations to 
confer 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 
r[eacute]sum[eacute] 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: October 9, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-22911 Filed 10-15-20; 8:45 am]
BILLING CODE 4164-01-P

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