83 FR 45253 - Request for Nominations on Public Advisory Panels of the Medical Devices Advisory Committee
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 173 (September 6, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 173 (September 6, 2018)
| Page Range | 45253-45254 | |
| FR Document | 2018-19350 |
[Federal Register Volume 83, Number 173 (Thursday, September 6, 2018)] [Notices] [Pages 45253-45254] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-19350] ----------------------------------------------------------------------- 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 October 9, 2018 (see sections I and II of this document for further details). Concurrently, nomination materials for prospective candidates should be sent to FDA by October 9, 2018. 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, Division of Workforce Management, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5264, Silver Spring, MD 20993, 301-796-5960, Fax: 301-847-8505, email: [email protected]. [[Page 45254]] 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 ------------------------------------------------------------------------ Dental Products Panel (two Reviews and evaluates data representatives--one to represent the concerning the safety and medical device industry, and one to effectiveness of marketed and represent 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 of Food and Drugs. Immunology Devices Panel............... Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational in vitro devices for use in clinical laboratory medicine including oncology, immunology, and allergy 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 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: August 31, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-19350 Filed 9-5-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 173 / Thursday, September 6, 2018 / Notices 45253
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent response
Full SE 905(j)(1)(A)(i) and 910(a) ........................................ 683 1 683 300 204,900
Full SE 905(j)(1)(A)(i) and 910(a) Bundled ......................... 456 1 456 90 41,040
Product Quantity Change SE Report .................................. 239 1 239 87 20,793
Product Quantity Change Bundled SE Report .................... 192 1 192 62 11,904
Total .............................................................................. ........................ ........................ ........................ ........................ 278,637
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA’s estimates are based on report for a total of 20,793 hours. This representatives to serve on certain
experience with SE Reports, initial includes time to prepare the device panels of the MDAC in the
updated deemed registration and listing environmental assessment, which FDA CDRH. A nominee may either be self-
data, interactions with the industry, and believes will take less time due to the nominated or nominated by an
information related to other regulated typically more limited modification(s) organization to serve as a nonvoting
products. The estimated number of SE included in a Product Quantity Change industry representative. Nominations
Reports is expected to increase from an SE Report. We estimate receiving 192 will be accepted for current and
annual average of 979 to 1,570. Product Quantity Change Bundled SE upcoming vacancies effective with this
When groups of full or product Reports at approximately 62 hours per notice.
quantity change SE Reports have submission for a total of 11,904 hours,
identical content, they may be bundled; this number excludes the time for the DATES: Any industry organization
when a group of similar reports are initial SE Report which was previously interested in participating in the
bundled, the subsequent bundled account for. selection of an appropriate nonvoting
reports are expected to take less time to Therefore, FDA estimates the burden member to represent industry interests
prepare than the initial report. for submission of SE information will be must send a letter stating that interest to
FDA has based these estimates on 278,637 hours. This is an increase of FDA by October 9, 2018 (see sections I
information it now has available from 106,759 hours from the currently and II of this document for further
interactions with the industry, approved burden. We attribute this details). Concurrently, nomination
information related to other regulated increase to an increase in the number of materials for prospective candidates
products, and FDA expectations SE Reports we expect related to Deemed should be sent to FDA by October 9,
regarding the tobacco industry’s use of products (e.g., based on the initial 2018.
the section 905(j) pathway to market registration and listing information).
their products. Table 1 describes the ADDRESSES: All statements of interest
annual reporting burden as a result of Dated: August 31, 2018. from industry organizations interested
the implementation of the substantial Leslie Kux, in participating in the selection process
equivalence requirements of sections Associate Commissioner for Policy. of nonvoting industry representative
905(j)(1)(A)(i) and 910(a) of the FD&C [FR Doc. 2018–19353 Filed 9–5–18; 8:45 am] nomination should be sent to Margaret
Act (21 U.S.C. 387j(a)) for an SE BILLING CODE 4164–01–P Ames (see FOR FURTHER INFORMATION
application. CONTACT). All nominations for
FDA estimates that 683 respondents nonvoting industry representatives
will prepare and submit 683 section DEPARTMENT OF HEALTH AND should be submitted electronically by
905(j)(1)(A)(i) SE Reports each year. In HUMAN SERVICES accessing the FDA Advisory Committee
addition, anyone submitting an SE Membership Nomination Portal: https://
Report is required to submit an Food and Drug Administration www.accessdata.fda.gov/scripts/
environmental assessment (EA) under [Docket No. FDA–2018–N–3179] FACTRSPortal/FACTRS/index.cfm or by
21 CFR 25.40. The burden for mail to Advisory Committee Oversight
environmental reports has been Request for Nominations on Public and Management Staff, Food and Drug
included in the burden per response for Advisory Panels of the Medical Administration, 10903 New Hampshire
each type of SE report. Based on FDA’s Devices Advisory Committee Ave., Bldg. 32, Rm. 5103, Silver Spring,
experience with EAs for currently MD 20993–0002. Information about
regulated tobacco products, we expect AGENCY: Food and Drug Administration, becoming a member of an FDA advisory
industry to spend 80 hours to prepare HHS. committee can also be obtained by
an environmental assessment for a SE ACTION: Notice. visiting FDA’s website at https://
Report. Thus, FDA estimates that it will www.fda.gov/AdvisoryCommittees/
take a manufacturer approximately 300 SUMMARY: The Food and Drug default.htm.
hours per report to prepare an SE Report Administration (FDA) is requesting that
and the EA for a new tobacco product, any industry organizations interested in FOR FURTHER INFORMATION CONTACT:
which is a total of 204,900 hours. participating in the selection of Margaret Ames, Division of Workforce
daltland on DSKBBV9HB2PROD with NOTICES
In addition, we estimate receiving 456 nonvoting industry representatives to Management, Center for Devices and
Full SE Bundled Reports at 90 hours per serve on certain panels of the Medical Radiological Health, Food and Drug
submission for a total of 41,040 hours. Devices Advisory Committee (MDAC or Administration, 10903 New Hampshire
FDA estimates that it will receive 239 Committee) in the Center for Devices Ave., Bldg. 66, Rm. 5264, Silver Spring,
Product Quantity Change SE Reports and Radiological Health (CDRH) notify MD 20993, 301–796–5960, Fax: 301–
and that it will take a manufacturer FDA in writing. FDA is also requesting 847–8505, email: margaret.ames@
approximately 87 hours to prepare this nominations for nonvoting industry fda.hhs.gov.
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![45254 Federal Register / Vol. 83, No. 173 / Thursday, September 6, 2018 / Notices
SUPPLEMENTARY INFORMATION: The according to its specialty area, advises and make recommendations on specific
Agency is requesting nominations for the Commissioner of Food and Drugs issues or problems concerning the safety
nonvoting industry representatives to (the Commissioner) regarding and effectiveness of devices. With the
the panels listed in the table in this recommended classification or exception of the Medical Devices
document. reclassification of devices into one of Dispute Resolution Panel, each panel,
I. Medical Devices Advisory Committee three regulatory categories; advises on according to its specialty area, may also
any possible risks to health associated make appropriate recommendations to
The Committee reviews and evaluates
with the use of devices; advises on the Commissioner on issues relating to
data on the safety and effectiveness of
marketed and investigational devices formulation of product development the design of clinical studies regarding
and makes recommendations for their protocols; reviews premarket approval the safety and effectiveness of marketed
regulation. The panels engage in a applications for medical devices; and investigational devices. The
number of activities to fulfill the reviews guidelines and guidance Committee also provides
functions the Federal Food, Drug, and documents; recommends exemption of recommendations to the Commissioner
Cosmetic Act (FD&C Act) envisions for certain devices from the application of or designee on complexity
device advisory panels. With the portions of the FD&C Act; advises on the categorization of in vitro diagnostics
exception of the Medical Devices necessity to ban a device; and responds under the Clinical Laboratory
Dispute Resolution Panel, each panel, to requests from the Agency to review Improvement Amendments of 1988.
Dental Products Panel (two representatives—one to represent the Reviews and evaluates data concerning the safety and effectiveness of
medical device industry, and one to represent the dental drug indus- marketed and investigational products for use in dentistry,
try). endodontics, or bone physiology relative to the oral and maxillofacial
area and makes appropriate recommendations to the Commissioner
of Food and Drugs.
Immunology Devices Panel ...................................................................... Reviews and evaluates data concerning the safety and effectiveness of
marketed and investigational in vitro devices for use in clinical lab-
oratory medicine including oncology, immunology, and allergy and
makes appropriate recommendations to the Commissioner of Food
and Drugs.
II. Qualifications IV. Application Procedure U.S.C. app. 2) and 21 CFR part 14,
Persons nominated for the device Individuals may self-nominate and/or relating to advisory committees.
panels should be full-time employees of an organization may nominate one or Dated: August 31, 2018.
firms that manufacture products that more individuals to serve as a nonvoting Leslie Kux,
would come before the panel, or industry representative. Nomination Associate Commissioner for Policy.
consulting firms that represent must include a current, complete [FR Doc. 2018–19350 Filed 9–5–18; 8:45 am]
manufacturers, or have similar résumé or curriculum vitae for each BILLING CODE 4164–01–P
appropriate ties to industry. nominee including current business
address and telephone number, email
III. Selection Procedure
address if available, and a signed copy DEPARTMENT OF HEALTH AND
Any industry organization interested of the Acknowledgement and Consent HUMAN SERVICES
in participating in the selection of an form available at the FDA Advisory
appropriate nonvoting member to Committee Membership Nomination Food and Drug Administration
represent industry interests should send Portal (see ADDRESSES) within 30 days of
a letter stating that interest to the FDA [Docket No. FDA–2014–D–0609]
publication of this document (see
contact (see FOR FURTHER INFORMATION DATES). Nominations must also specify Agency Information Collection
CONTACT) within 30 days of publication the advisory panel for which the Activities; Proposed Collection;
of this document (see DATES). Within the nominee is recommended. Nominations Comment Request; Guidance for
subsequent 30 days, FDA will send a must also acknowledge that the Industry: Drug Supply Chain Security
letter to each organization that has nominee is aware of the nomination Act Implementation: Identification of
expressed an interest, attaching a unless self-nominated. FDA will Suspect Product and Notification
complete list of all such organizations; forward all nominations to the
and a list of all nominees along with organizations expressing interest in AGENCY: Food and Drug Administration,
their current resumes. The letter will participating in the selection process for HHS.
also state that it is the responsibility of the particular device panels listed in the ACTION: Notice.
the interested organizations to confer table. (Persons who nominate
with one another and to select a themselves as nonvoting industry SUMMARY: The Food and Drug
candidate, within 60 days after the representatives will not participate in Administration (FDA or Agency) is
receipt of the FDA letter, to serve as the the selection process). announcing an opportunity for public
nonvoting member to represent industry FDA seeks to include the views of comment on the proposed collection of
interests for a particular device panel. women and men, members of all racial certain information by the Agency.
daltland on DSKBBV9HB2PROD with NOTICES
The interested organizations are not and ethnic groups, and individuals with Under the Paperwork Reduction Act of
bound by the list of nominees in and without disabilities on its advisory 1995 (PRA), Federal Agencies are
selecting a candidate. However, if no committees and, therefore, encourages required to publish notice in the
individual is selected within 60 days, nominations of appropriately qualified Federal Register concerning each
the Commissioner will select the candidates from these groups. proposed collection of information,
nonvoting member to represent industry This notice is issued under the including each proposed extension of an
interests. Federal Advisory Committee Act (5 existing collection of information, and
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Document Created: 2018-09-05 23:56:20
Document Modified: 2018-09-05 23:56:20
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | 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 October 9, 2018 (see sections I and II of this document for further details). Concurrently, nomination materials for prospective candidates should be sent to FDA by October 9, 2018. | |
| Contact | Margaret Ames, Division of Workforce Management, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5264, Silver Spring, MD 20993, 301-796-5960, Fax: 301-847-8505, email: [email protected] | |
| FR Citation | 83 FR 45253 |
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