81 FR 7803 - Request for Nominations for Individuals and Consumer Organizations for Advisory Committees
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 30 (February 16, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 30 (February 16, 2016)
| Page Range | 7803-7806 | |
| FR Document | 2016-03010 |
[Federal Register Volume 81, Number 30 (Tuesday, February 16, 2016)] [Notices] [Pages 7803-7806] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-03010] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0001] Request for Nominations for Individuals and Consumer Organizations for Advisory Committees AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. 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. DATES: Any consumer organization interested in participating in the selection of an appropriate voting or nonvoting member to represent consumer interests on an FDA advisory committee or panel may send a letter or email stating that interest to FDA (see ADDRESSES) by March 17, 2016, for vacancies listed in this notice. Concurrently, nomination materials for prospective candidates should be sent to FDA (see ADDRESSES) by March 17, 2016. Nominations will be accepted for current vacancies and for those that will or may occur through March 31, 2016. ADDRESSES: All statements of interest from consumer organizations interested in participating in the selection process and consumer representative nominations should be submitted electronically to [email protected], by mail to Advisory Committee Oversight and Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993-0002, or by FAX: 301-847-8640. Consumer Representative nominations should be submitted electronically by logging into the FDA Advisory Committee Membership Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm, by mail to Advisory Committee Oversight and Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993-0002, or by FAX: 301-847-8640. Additional information about becoming a member on an FDA advisory committee can also be obtained by visiting FDA's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm. FOR FURTHER INFORMATION CONTACT: For questions relating to participation in the selection process: Kimberly Hamilton, Advisory Committee Oversight and Management Staff (ACOMS), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32., Rm. 5117, Silver Spring, MD 20993-0002, 301-796-8224, email: [email protected]. For questions relating to specific advisory committees or panels, contact the appropriate Contact Person listed in table 1 in the SUPPLEMENTARY INFORMATION section. SUPPLEMENTARY INFORMATION: I. Background FDA is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing (see table 1 for Contact Person). Table 1--Advisory Committee Contacts ------------------------------------------------------------------------ Contact person Committee/panel ------------------------------------------------------------------------ Janie Kim, Center for Biologics Evaluation Cellular, Tissue and Gene and Research, Food and Drug Therapies. Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6129, Silver Spring, MD 20993-0002, Phone: 301-796-9016, Email: [email protected]. Philip Bautista, Center for Drugs Drug Safety and Risk Evaluation and Research, Food and Drug Management Advisory Administration, 10903 New Hampshire Ave., Committee. Bldg. 31, Rm. 2410, Silver Spring, MD 20993-0002, Phone: 301-796-9006, Email: [email protected]. Natasha Facey, Center for Devices and Immunology Devices Panel. Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1552, Silver Spring, MD 20993-0002, Phone: 301-796-5290, Email: [email protected]. [[Page 7804]] Terri Crescenzi, Office of the Pediatrics Advisory Commissioner, Food and Drug Committee. Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5152, Silver Spring, MD 20993-0002, Phone: 301-796-8646, Email: [email protected]. Donna Mendrick, National Center for Science Advisory Board to Toxicological Research, Food and Drug National Center for Administration, 10903 New Hampshire Ave., Toxicological Research Bldg. 32, Rm. 2208, Silver Spring, MD (NCTR). 20993-0002, Phone: 301-796-8892, Email: [email protected]. Bryan Emery, Center for Biologics Transmissible Spongiform Evaluation and Research, Food and Drug Encephalopathies Advisory Administration, 10903 New Hampshire Ave., Committee. Bldg. 71, Rm. 6132, Silver Spring, MD 20993-0002, Phone: 240-402-8054, Email: [email protected]. Sujata Vijh, Center for Biologics Vaccines and Related Evaluation and Research, Food and Drug Biological Products Administration, 10903 New Hampshire Ave., Advisory Committee. Bldg. 71, Rm. 6128, Silver Spring, MD 20993-0002, Phone: 240-402-7107, Email: [email protected]. ------------------------------------------------------------------------ FDA is requesting nominations for voting and/or nonvoting consumer representatives for the vacancies listed in table 2. Table 2--Committee Descriptions, Type of Consumer Representative Vacancy and Approximate Date Needed ---------------------------------------------------------------------------------------------------------------- Committee/panel/areas of expertise needed Type of vacancy Approximate date needed ---------------------------------------------------------------------------------------------------------------- Cellular, Tissue and Gene Therapies Advisory 1-Voting..................... 3/31/2016. Committee--Knowledgeable in the fields of cellular therapies, tissue transplantation, gene transfer therapies and xenotransplantation (biostatistics, bioethics, hematology/oncology, human tissues and transplantation, reproductive medicine, general medicine and various medical specialties including surgery and oncology, immunology, virology, molecular biology, cell biology, developmental biology, tumor biology, biochemistry, rDNA technology, nuclear medicine, gene therapy, infectious diseases, and cellular kinetics. Drug Safety and Risk Management Advisory 1-Voting..................... Immediately. Committee--Knowledgeable in risk communication, risk management, drug safety, medical, behavioral, and biological sciences as they apply to risk management, and drug abuse. Immunology Devices Panel--Persons with experience 1-Non-Voting................. 2/28/2016. in medical, surgical, or clinical oncology, internal medicine, clinical immunology, allergy, molecular diagnostics, or clinical laboratory medicine. Pediatrics Advisory Committee--Knowledgeable in 1-Voting..................... Immediately. pediatric research, pediatric subspecialties, statistics, and/or biomedical ethics. The core of voting members shall also include one representative from a pediatric health organization and one representative from a relevant patient or patient-family organization and may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumer- oriented organizations or other interested persons. In addition to the voting members, the Committee may include one non-voting member who is identified with industry interests. Science Advisory Board to the NCTR--Knowledgeable 1-Voting..................... Immediately. in the fields related to toxicological research. Transmissible Spongiform Encephalopathies Advisory 1-Voting..................... Immediately. Committee--Knowledgeable in the fields of clinical and administrative medicine, hematology, virology, neurovirology, neurology, infectious diseases, immunology, transfusion medicine, surgery, internal medicine, biochemistry, biostatistics, epidemiology, biological and physical sciences, sociology/ethics, and other related professions. Vaccines and Related Biological Products Advisory 1-Voting..................... Immediately. Committee--Knowledgeable in the fields of immunology, molecular biology, rDNA, virology, bacteriology, epidemiology or biostatistics, allergy, preventive medicine, infectious diseases, pediatrics, microbiology, and biochemistry. ---------------------------------------------------------------------------------------------------------------- II. Functions and General Description of the Committee Duties A. Cellular, Tissue, and Gene Therapies Advisory Committee Reviews and evaluates available data relating to the safety, effectiveness, and appropriate use of human cells, human tissues, gene transfer therapies and xenotransplantation products which are intended for transplantation, implantation, infusion and transfer in the prevention and treatment of a broad spectrum of human diseases and in the reconstruction, repair or replacement of tissues for various conditions, as well as considers the quality and relevance of FDA's research program which provides scientific support for the regulation of these products. B. Drug Safety and Risk Management Advisory Committee Risk management, risk communication, and quantitative evaluation of spontaneous reports for drugs for human use and for any other product for which the FDA has regulatory responsibility. Scientific and medical evaluation of all information gathered by the Department of Health and Human Service (DHHS) and the Department of Justice with regard to safety, efficacy, and abuse potential of drugs or other substances, and recommends actions to be taken by DHHS with regard to the marketing, investigation, and control of such drugs or other substances. C. Certain Panels of the 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 act) envisions for device advisory panels. With the exception of the Medical Devices Dispute Resolution Panel, each panel, according to its specialty area, advises [[Page 7805]] 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 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 Dental Products Panel also functions at times as a dental drug panel. The functions of the dental drug panel are to evaluate and recommend whether various prescription drug products should be changed to over-the-counter status and to evaluate data and make recommendations concerning the approval of new dental drug products for human use. D. Pediatrics Advisory Committee The Committee advises and makes recommendations to the Commissioner of Food and Drugs regarding: (1) Pediatric research; (2) identification of research priorities related to pediatric therapeutics and the need for additional treatments of specific pediatric diseases or conditions; (3) the ethics, design, and analysis of clinical trials related to pediatric therapeutics; (4) pediatric labeling disputes; (5) pediatric labeling changes; (6) adverse event reports for drugs granted pediatric exclusivity and any safety issues that may occur; (7) any other pediatric issue or pediatric labeling dispute involving FDA regulated products; (8) research involving children as subjects; and (9) any other matter involving pediatrics for which FDA has regulatory responsibility. The Committee also advises and makes recommendations to the Secretary directly or to the Secretary through the Commissioner on research involving children as subjects that is conducted or supported by DHHS. E. Science Advisory Board to the National Center for Toxicological Research Reviews and advises the Agency on the establishment, implementation and evaluation of the research programs and regulatory responsibilities as it relates to NCTR. The Board will also provide an extra-agency review in ensuring that the research programs at NCTR are scientifically sound and pertinent. F. Transmissible Spongiform Encephalopathies Advisory Committee Reviews and evaluates available scientific data concerning the safety of products which may be at risk for transmission of spongiform encephalopathies having an impact on the public health, as well as considers the quality and relevance of FDA's research program which provides scientific support for the regulation of these products. G. Vaccines and Related Biological Products Advisory Committee Reviews and evaluates data concerning the safety, effectiveness, and appropriate use of vaccines and related biological products which are intended for use in the prevention, treatment, or diagnosis of human diseases, as well as considers the quality and relevance of FDA's research program which provides scientific support for the regulation of these products. III. Criteria for Members Persons nominated for membership as consumer representatives on committees or panels should meet the following criteria: (1) Demonstrate ties to consumer and community-based organizations, (2) be able to analyze technical data, (3) understand research design, (4) discuss benefits and risks, and (5) evaluate the safety and efficacy of products under review. The consumer representative should be able to represent the consumer perspective on issues and actions before the advisory committee; serve as a liaison between the committee and interested consumers, associations, coalitions, and consumer organizations; and facilitate dialogue with the advisory committees on scientific issues that affect consumers. IV. Selection Procedures Selection of members representing consumer interests is conducted through procedures that include the use of organizations representing the public interest and public advocacy groups. These organizations recommend nominees for the Agency's selection. Representatives from the consumer health branches of Federal, State, and local governments also may participate in the selection process. Any consumer organization interested in participating in the selection of an appropriate voting or nonvoting member to represent consumer interests should send a letter stating that interest to FDA (see ADDRESSES) within 30 days of publication of this document. Within the subsequent 30 days, FDA will compile a list of consumer organizations that will participate in the selection process and will forward to each such organization a ballot listing at least two qualified nominees selected by the Agency based on the nominations received, together with each nominee's current curriculum vitae or resume. Ballots are to be filled out and returned to FDA within 30 days. The nominee receiving the highest number of votes ordinarily will be selected to serve as the member representing consumer interests for that particular advisory committee or panel. V. Nomination Procedures Any interested person or organization may nominate one or more qualified persons to represent consumer interests on the Agency's advisory committees or panels. Self-nominations are also accepted. Nominations should include a cover letter and current curriculum vitae or r[eacute]sum[eacute] for each nominee, including a current business and/or home address, telephone number, and email address if available, and a list of consumer or community-based organizations for which the candidate can demonstrate active participation. Nominations should also specify the advisory committee(s) or panel(s) for which the nominee is recommended. In addition, nominations should include confirmation that the nominee is aware of the nomination, unless self-nominated. FDA will ask potential candidates to provide detailed information concerning such matters as financial holdings, employment, and research grants and/or contracts to permit evaluation of possible sources of conflicts of interest. Members will be invited to serve for terms up to 4 years. FDA will review all nominations received within the specified timeframes and prepare a ballot containing the names of qualified nominees. Names not selected will remain on a list of eligible nominees and be reviewed periodically by FDA to determine continued interest. Upon selecting qualified nominees for the ballot, FDA will provide those consumer organizations that are participating in the selection process with the opportunity to vote on the [[Page 7806]] listed nominees. Only organizations vote in the selection process. Persons who nominate themselves to serve as voting or nonvoting consumer representatives will not participate in the selection process. 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: February 8, 2016. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. [FR Doc. 2016-03010 Filed 2-12-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 30 / Tuesday, February 16, 2016 / Notices 7803
Government nonmember—$525, and DEPARTMENT OF HEALTH AND ADDRESSES: All statements of interest
FDA Employee—(free) Fee Waived. HUMAN SERVICES from consumer organizations interested
Attendees are responsible for their in participating in the selection process
own accommodations. Please mention Food and Drug Administration and consumer representative
SOCRA to receive the hotel room rate of [Docket No. FDA–2016–N–0001] nominations should be submitted
$142 plus applicable taxes (available electronically to kimberly.hamilton@
until the SOCRA room block is filled). Request for Nominations for fda.hhs.gov, by mail to Advisory
If you need special accommodations Individuals and Consumer Committee Oversight and Management
due to a disability, please contact Organizations for Advisory Staff, 10903 New Hampshire Ave., Bldg.
SOCRA (see FOR FURTHER INFORMATION Committees 32, Rm. 5103, Silver Spring, MD 20993–
CONTACT) at least 21 days in advance. 0002, or by FAX: 301–847–8640.
Extended periods of question and AGENCY: Food and Drug Administration,
Consumer Representative
answer and discussion have been HHS.
nominations should be submitted
included in the program schedule. ACTION: Notice. electronically by logging into the FDA
SOCRA designates this education Advisory Committee Membership
activity for a maximum of 13.3 SUMMARY: The Food and Drug
Administration (FDA) is requesting that Nomination Portal: https://
Continuing Education (CE) Credits for www.accessdata.fda.gov/scripts/
SOCRA CE and Nurse CNE; SOCRA any consumer organizations interested
in participating in the selection of FACTRSPortal/FACTRS/index.cfm, by
designates this live activity for a mail to Advisory Committee Oversight
maximum of 13.3 AMA PRA Category 1 voting and/or nonvoting consumer
representatives to serve on its advisory and Management Staff, 10903 New
Credit(s)TM. Physicians should claim Hampshire Ave., Bldg. 32, Rm. 5103,
committees or panels notify FDA in
only the credit commensurate with the Silver Spring, MD 20993–0002, or by
writing. FDA is also requesting
extent of their participation. CME for FAX: 301–847–8640. Additional
nominations for voting and/or
Physicians: SOCRA is accredited by the information about becoming a member
nonvoting consumer representatives to
Accreditation Council for Continuing on an FDA advisory committee can also
serve on advisory committees and/or
Medical Education to provide be obtained by visiting FDA’s Web site
panels for which vacancies currently
continuing medical education for at http://www.fda.gov/
exist or are expected to occur in the near
physicians. CNE for Nurses: Society of AdvisoryCommittees/default.htm.
future. Nominees recommended to serve
Clinical Research Associates is
as a voting or nonvoting consumer FOR FURTHER INFORMATION CONTACT: For
accredited as a provider of continuing
representative may be self-nominated or questions relating to participation in the
nursing education by the American
may be nominated by a consumer selection process: Kimberly Hamilton,
Nurses Credentialing Center’s
organization. Advisory Committee Oversight and
Commission on Accreditation.
FDA seeks to include the views of Management Staff (ACOMS), Food and
Registration Instructions: To register,
women and men, members of all racial Drug Administration, 10903 New
please submit a registration form with
and ethnic groups, and individuals with Hampshire Ave., Bldg. 32., Rm. 5117,
your name, affiliation, mailing address,
and without disabilities on its advisory Silver Spring, MD 20993–0002, 301–
telephone, fax number, and email, along
committees and, therefore, encourages 796–8224, email: kimberly.hamilton@
with a check or money order payable to
nominations of appropriately qualified fda.hhs.gov.
‘‘SOCRA.’’ Mail to: SOCRA (see FOR
candidates from these groups. For questions relating to specific
FURTHER INFORMATION CONTACT). To
register via the Internet, go to http:// DATES: Any consumer organization advisory committees or panels, contact
www.socra.org/html/ interested in participating in the the appropriate Contact Person listed in
FDAConference.htm. Payment by major selection of an appropriate voting or table 1 in the SUPPLEMENTARY
credit card is accepted (Visa/ nonvoting member to represent INFORMATION section.
MasterCard/AMEX only). For more consumer interests on an FDA advisory
committee or panel may send a letter or SUPPLEMENTARY INFORMATION:
information on the meeting registration,
or for questions on the workshop, email stating that interest to FDA (see I. Background
contact SOCRA (see FOR FURTHER ADDRESSES) by March 17, 2016, for
INFORMATION CONTACT). vacancies listed in this notice. FDA is requesting that any consumer
Concurrently, nomination materials for organizations interested in participating
Dated: February 9, 2016. prospective candidates should be sent to in the selection of voting and/or
Leslie Kux, FDA (see ADDRESSES) by March 17, nonvoting consumer representatives to
Associate Commissioner for Policy. 2016. Nominations will be accepted for serve on its advisory committees or
[FR Doc. 2016–02965 Filed 2–12–16; 8:45 am] current vacancies and for those that will panels notify FDA in writing (see table
BILLING CODE 4164–01–P or may occur through March 31, 2016. 1 for Contact Person).
TABLE 1—ADVISORY COMMITTEE CONTACTS
Contact person Committee/panel
Janie Kim, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Cellular, Tissue and Gene Thera-
mstockstill on DSK4VPTVN1PROD with NOTICES
Hampshire Ave., Bldg. 71, Rm. 6129, Silver Spring, MD 20993–0002, Phone: 301–796–9016, Email: pies.
Janie.Kim@fda.hhs.gov.
Philip Bautista, Center for Drugs Evaluation and Research, Food and Drug Administration, 10903 New Drug Safety and Risk Management
Hampshire Ave., Bldg. 31, Rm. 2410, Silver Spring, MD 20993–0002, Phone: 301–796–9006, Email: Advisory Committee.
Philip.Bautista@fda.hhs.gov.
Natasha Facey, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Immunology Devices Panel.
Hampshire Ave., Bldg. 66, Rm. 1552, Silver Spring, MD 20993–0002, Phone: 301–796–5290, Email:
Natasha.Facey@fda.hhs.gov.
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![7806 Federal Register / Vol. 81, No. 30 / Tuesday, February 16, 2016 / Notices
listed nominees. Only organizations ADDRESSES: The public workshop will Workshop; Request for Comments’’.
vote in the selection process. Persons be held at the University of Maryland, Received comments will be placed in
who nominate themselves to serve as Pharmacy Hall, 20 North Pine St., the docket and, except for those
voting or nonvoting consumer Baltimore, MD 21201. For additional submitted as ‘‘Confidential
representatives will not participate in travel and hotel information, please Submissions,’’ publicly viewable at
the selection process. refer to www.pharmacy.umaryland.edu/ http://www.regulations.gov or at the
This notice is issued under the DeviceEval. (FDA has verified the Web Division of Dockets Management
Federal Advisory Committee Act (5 site addresses throughout this notice, between 9 a.m. and 4 p.m., Monday
U.S.C. app. 2) and 21 CFR part 14, but FDA is not responsible for through Friday.
relating to advisory committees. subsequent changes to the Web sites • Confidential Submissions—To
Dated: February 8, 2016. after this document publishes in the submit a comment with confidential
Jill Hartzler Warner, Federal Register). information that you do not wish to be
Associate Commissioner for Special Medical You may submit comments as made publicly available submit your
Programs. follows: comments only as a written/paper
[FR Doc. 2016–03010 Filed 2–12–16; 8:45 am] Electronic Submissions submission. You should submit two
BILLING CODE 4164–01–P
Submit electronic comments in the copies total. One copy will include the
following way: information you claim to be confidential
• Federal eRulemaking Portal: http:// with a heading or cover note that states
DEPARTMENT OF HEALTH AND ‘‘THIS DOCUMENT CONTAINS
www.regulations.gov. Follow the
HUMAN SERVICES CONFIDENTIAL INFORMATION.’’ The
instructions for submitting comments.
Comments submitted electronically, Agency will review this copy, including
Food and Drug Administration the claimed confidential information, in
including attachments, to http://
[Docket No. FDA–2016–N–0382] www.regulations.gov will be posted to its consideration of comments. The
the docket unchanged. Because your second copy, which will have the
Building the National Evaluation claimed confidential information
comment will be made public, you are
System for Medical Devices: Using redacted/blacked out, will be available
solely responsible for ensuring that your
Real-World Evidence To Improve for public viewing and posted on
comment does not include any
Device Safety and Effectiveness; http://www.regulations.gov. Submit
confidential information that you or a
Public Workshop; Request for both copies to the Division of Dockets
Comments third party may not wish to be posted,
such as medical information, your or Management. If you do not wish your
AGENCY: Food and Drug Administration, anyone else’s Social Security number, or name and contact information to be
HHS. confidential business information, such made publicly available, you can
ACTION: Notice of public workshop; as a manufacturing process. Please note provide this information on the cover
request for comments. that if you include your name, contact sheet and not in the body of your
information, or other information that comments and you must identify this
SUMMARY: The Food and Drug identifies you in the body of your information as ‘‘confidential.’’ Any
Administration (FDA), in collaboration comments, that information will be information marked as ‘‘confidential’’
with the University of Maryland Center posted on http://www.regulations.gov. will not be disclosed except in
of Excellence in Regulatory Science and • If you want to submit a comment accordance with 21 CFR 10.20 and other
Innovation, is announcing a public with confidential information that you applicable disclosure law. For more
workshop titled ‘‘Building the National do not wish to be made available to the information about FDA’s posting of
Evaluation System for Medical Devices: public, submit the comment as a comments to public dockets, see 80 FR
Using Real-World Evidence to Improve written/paper submission and in the 56469, September 18, 2015, or access
Device Safety and Effectiveness.’’ The manner detailed (see ‘‘Written/Paper the information at: http://www.fda.gov/
objective of the workshop is to discuss Submissions’’ and ‘‘Instructions’’). regulatoryinformation/dockets/
the scientific progress being made in default.htm.
harnessing evidence generated from the Written/Paper Submissions
Docket: For access to the docket to
real-world use of medical devices to Submit written/paper submissions as read background documents or the
improve device safety and effectiveness. follows: electronic and written/paper comments
A national evaluation system for • Mail/Hand delivery/Courier (for received, go to http://
medical devices, which leverages real- written/paper submissions): Division of www.regulations.gov and insert the
world evidence, can help FDA more Dockets Management (HFA–305), Food docket number, found in brackets in the
efficiently strike the right balance and Drug Administration, 5630 Fishers heading of this document, into the
between premarket and postmarket data Lane, Rm. 1061, Rockville, MD 20852. ‘‘Search’’ box and follow the prompts
collection, facilitate access to medical • For written/paper comments and/or go to the Division of Dockets
devices, and more quickly and robustly submitted to the Division of Dockets Management, 5630 Fishers Lane, Rm.
identify safety signals that may arise in Management, FDA will post your 1061, Rockville, MD 20852.
the postmarket period. The promise of comment, as well as any attachments,
using real-world evidence to promote except for information submitted, FOR FURTHER INFORMATION CONTACT: Ann
the safety and effectiveness of medical marked and identified, as confidential, Anonsen, University of Maryland,
devices can only be achieved through
mstockstill on DSK4VPTVN1PROD with NOTICES
if submitted as detailed in Fischell Department of Bioengineering,
robust public-private partnerships and ‘‘Instructions.’’ 2207 Jeong H. Kim Bldg., College Park,
new approaches to informatics, Instructions: All submissions received MD 20742, 301–405–0285, FAX: 304–
epidemiology, biostatistics, and must include the Docket No. FDA– 405–9953, aanonsen@umd.edu; or
healthcare data systems integration. 2016–N–0382 for ‘‘Building the National Audrey Thomas, Office of Regulatory
DATES: The public workshop will be Evaluation System for Medical Devices: Science and Innovation, Food and Drug
held on March 24, 2016, from 8:30 a.m. Using Real-World Evidence to Improve Administration, 10903 New Hampshire
to 4:30 p.m. Device Safety and Effectiveness; Public Ave., Bldg. 1, Rm. 4220, Silver Spring,
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Document Created: 2016-02-13 03:13:46
Document Modified: 2016-02-13 03:13:46
| 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 consumer organization interested in participating in the selection of an appropriate voting or nonvoting member to represent consumer interests on an FDA advisory committee or panel may send a | |
| Contact | For questions relating to participation in the selection process: Kimberly Hamilton, Advisory Committee Oversight and Management Staff (ACOMS), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32., Rm. 5117, Silver Spring, MD 20993-0002, 301-796-8224, email: [email protected] | |
| FR Citation | 81 FR 7803 |
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