81_FR_69256 81 FR 69063 - Request for Nominations for Voting Members for the Patient Engagement Advisory Committee

81 FR 69063 - Request for Nominations for Voting Members for the Patient Engagement Advisory Committee

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 193 (October 5, 2016)

Page Range69063-69064
FR Document2016-24100

The Food and Drug Administration's (FDA) is requesting additional nominations for members to serve on the Center for Devices and Radiological Health's (CDRH) Patient Engagement Advisory Committee (the PEAC or Committee). The Committee provides relevant skills and perspectives in order to improve communication of benefits, risks and clinical outcomes, and increase integration of patient perspectives into the regulatory process for medical devices. It performs its duties by identifying new approaches, promoting innovation, recognizing unforeseen risks or barriers, and identifying unintended consequences that could result from FDA policy. 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, particularly encourages nominations of appropriately qualified candidates from these groups.

Federal Register, Volume 81 Issue 193 (Wednesday, October 5, 2016) 
[Federal Register Volume 81, Number 193 (Wednesday, October 5, 2016)]
[Notices]
[Pages 69063-69064]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-24100]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]


Request for Nominations for Voting Members for the Patient 
Engagement Advisory Committee

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for nominations.

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SUMMARY: The Food and Drug Administration's (FDA) is requesting 
additional nominations for members to serve on the Center for Devices 
and

[[Page 69064]]

Radiological Health's (CDRH) Patient Engagement Advisory Committee (the 
PEAC or Committee). The Committee provides relevant skills and 
perspectives in order to improve communication of benefits, risks and 
clinical outcomes, and increase integration of patient perspectives 
into the regulatory process for medical devices. It performs its duties 
by identifying new approaches, promoting innovation, recognizing 
unforeseen risks or barriers, and identifying unintended consequences 
that could result from FDA policy.
    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, particularly encourages 
nominations of appropriately qualified candidates from these groups.

DATES: Nominations received by November 21, 2016, will be given first 
consideration for membership on the Committee. Nominations received 
after November 21, 2016, will be considered for nomination to the 
Committee as later vacancies occur.

ADDRESSES: All nominations for membership should be sent electronically 
by logging into the FDA Advisory Committee Membership Nomination 
Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm please select Academician/Practitioner in the drop down menu, 
to apply for membership, 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, or by FAX: 301-
847-8640. 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: Letise Williams, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave. Bldg. 66, Rm. 5441, 301-796-8398, FAX: 301-847-8510, 
[email protected].

SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting 
members for the Committee. 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.

I. General Description of the Committee's Duties

    The PEAC provides relevant skills and perspectives in order to 
improve communication of benefits, risks, and clinical outcomes and 
increase integration of patient perspectives into the regulatory 
process for medical devices.
    The PEAC provides advice on issues relating to medical devices, the 
regulation of devices, and their use by patients. A variety of topics 
may be considered by the PEAC, including Agency guidance and policies, 
clinical trial or registry design, patient preference study design, 
benefit-risk determinations, device labeling, unmet clinical needs, 
available alternatives, patient reported outcomes and device-related 
quality of life or health status issues.

II. Criteria for Voting Members

    The Committee consists of a core of nine voting members including 
the Chair. Members and the Chair are selected by the Commissioner of 
Food and Drugs or designee from candidates who are knowledgeable in 
areas such as clinical research, primary care patient experience, 
healthcare needs of patient groups in the United States, or are 
experienced in the work of patient and health professional 
organizations, methodologies for eliciting patient preferences, and 
strategies for communicating benefits, risks, and clinical outcomes to 
patients and research participants. Prospective members should also 
have an understanding of the broad spectrum of patients in a particular 
disease area.
    Members will be invited to serve for overlapping terms of up to 4 
years. Non-Federal members of this Committee serve as Special 
Government Employees, with the exception of the representatives from 
Industry.

III. Nomination Procedures

    Any interested person may nominate one or more qualified 
individuals for membership on the Committee. Self-nominations are also 
accepted.
    Nominations should include a cover letter; a current, complete 
resume or curriculum vitae for each nominee, including a current 
business and/or home address, telephone number, and email address if 
available; and should specify the advisory committee for which the 
nominee is recommended.
    Nominations should also acknowledge that the nominee is aware of 
the nomination, unless self-nominated. FDA will ask potential 
candidates to provide detailed information concerning such matters 
related to financial holdings, employment, and research grants and/or 
contracts to permit evaluation of possible sources of conflicts of 
interest.
    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: September 28, 2016.
Janice M. Soreth,
Acting Associate Commissioner, Special Medical Programs.
[FR Doc. 2016-24100 Filed 10-4-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 193 / Wednesday, October 5, 2016 / Notices 69063 monograph does not exist, is a A condition that must be satisfied to nominated for inclusion on the 503A component of a drug approved by the qualify for the exemptions in section Bulks List and drug products nominated Secretary of Health and Human Services 503B of the FD&C Act is that the for inclusion on the list of drug products (the Secretary); or (3) if such a compounded drug is not identified that present demonstrable difficulties monograph does not exist and the drug (directly or as part of a category of for compounding under sections 503A substance is not a component of a drug drugs) on a list, published by the and 503B of the FD&C Act (‘‘Difficult to approved by the Secretary, appears on a Secretary by regulation after consulting Compound List’’). list developed by the Secretary through with the PCAC, of drugs or categories of Agenda: The committee intends to regulations issued by the Secretary (the drugs that present demonstrable discuss five bulk drug substances ‘‘503A Bulks List’’) (see section difficulties for compounding that are reasonably likely to lead to an adverse nominated for inclusion on the section 503A(b)(1)(A)(i) of the FD&C Act). 503A Bulks List. FDA will discuss the effect on the safety or effectiveness of Another condition that must be the drug or category of drugs, taking into following nominated bulk drug satisfied to qualify for the exemptions account the risks and benefits to substances: Glycolic acid, under section 503A of the FD&C Act is patients, or the drug is compounded in trichloroacetic acid, kojic acid, that the compounded drug product is accordance with all applicable diindolylmethane, and vasoactive not a drug product identified by the conditions identified on the list as intestinal peptide. The chart in this Secretary by regulation as a drug conditions that are necessary to prevent document describes which use(s) FDA product that presents demonstrable the drug or category of drugs from reviewed for each of the five bulk drug difficulties for compounding that presenting such demonstrable substances being discussed at this reasonably demonstrate an adverse difficulties (see section 503B(a)(6)(A) advisory committee meeting. The effect on the safety or effectiveness of and (B) of the FD&C Act). nominators of these substances will be that drug product (see section FDA intends to discuss with the invited to make a short presentation 503A(b)(3)(A) of the FD&C Act). committee bulk drug substances supporting the nomination. Drug Use(s) reviewed Diindolylmethane ................................................ Treatment of cancer. Glycolic acid ........................................................ Hyperpigmentation (including melasma) and photodamaged skin. Trichloroacetic acid ............................................. Common warts and genital warts. Kojic acid ............................................................ Hyperpigmentation and as a chelating agent to promote wound healing. Vasoactive intestinal peptide .............................. A condition described as ‘‘chronic inflammatory response syndrome’’. The committee also intends to discuss November 3, 2016. Those individuals http://www.fda.gov/ drug products that employ transdermal interested in making formal oral AdvisoryCommittees/ and topical delivery systems, which presentations should notify Cindy Hong AboutAdvisoryCommittees/ were nominated for the Difficult to and submit a brief statement of the ucm111462.htm for procedures on Compound List. The nominators will be general nature of the evidence or public conduct during advisory invited to make a short presentation arguments they wish to present, the committee meetings. supporting the nomination. names and addresses of proposed Notice of this meeting is given under FDA intends to make background participants, and an indication of the the Federal Advisory Committee Act (5 material available to the public on its approximate time requested to make U.S.C. app. 2). Web site no later than 2 business days their presentation on or before October Dated: September 30, 2016. before the meeting. If FDA is unable to 17, 2016. Time allotted for each Janice M. Soreth, post the background material on its Web presentation may be limited. If the Acting Associate Commissioner, Special site prior to the meeting, the background number of registrants requesting to Medical Programs. material will be made publicly available speak is greater than can be reasonably [FR Doc. 2016–24085 Filed 10–4–16; 8:45 am] at the location of the advisory accommodated during the scheduled BILLING CODE 4164–01–P committee meeting, and the background open public hearing session, FDA may material will be posted on FDA’s Web conduct a lottery to determine the site after the meeting. Background speakers for the scheduled open public DEPARTMENT OF HEALTH AND material will be available at http:// hearing session. The contact person will HUMAN SERVICES www.fda.gov/AdvisoryCommittees/ notify interested persons regarding their Calendar/default.htm. Scroll down to request to speak by October 18, 2016. Food and Drug Administration the appropriate advisory committee Persons attending FDA’s advisory meeting link. committee meetings are advised that the [Docket No. FDA–2016–N–0001] Procedure: Interested persons may Agency is not responsible for providing Request for Nominations for Voting present data, information, or views, access to electrical outlets. Members for the Patient Engagement orally or in writing, on issues pending FDA welcomes the attendance of the Advisory Committee before the committee. Written public at its advisory committee asabaliauskas on DSK3SPTVN1PROD with NOTICES submissions may be made to the contact meetings and will make every effort to AGENCY: Food and Drug Administration, person on or before October 25, 2016. accommodate persons with disabilities. HHS. Oral presentations from the public will If you require accommodations due to a ACTION: Notice; request for nominations. be scheduled between approximately disability, please contact Cindy Hong at 9:25 a.m. and 9:35 a.m., 10:25 a.m. and least 7 days in advance of the meeting. SUMMARY: The Food and Drug 10:35 a.m., 11:40 a.m. and 11:50 a.m., FDA is committed to the orderly Administration’s (FDA) is requesting 1:45 p.m. and 1:55 p.m., 2:50 p.m. and conduct of its advisory committee additional nominations for members to 3 p.m., and 4:10 p.m. and 4:20 p.m. on meetings. Please visit our Web site at serve on the Center for Devices and VerDate Sep<11>2014 18:15 Oct 04, 2016 Jkt 241001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 E:\FR\FM\05OCN1.SGM 05OCN1

69064 Federal Register / Vol. 81, No. 193 / Wednesday, October 5, 2016 / Notices Radiological Health’s (CDRH) Patient I. General Description of the information concerning such matters Engagement Advisory Committee (the Committee’s Duties related to financial holdings, PEAC or Committee). The Committee The PEAC provides relevant skills employment, and research grants and/or provides relevant skills and and perspectives in order to improve contracts to permit evaluation of perspectives in order to improve communication of benefits, risks, and possible sources of conflicts of interest. communication of benefits, risks and This notice is issued under the clinical outcomes and increase clinical outcomes, and increase Federal Advisory Committee Act (5 integration of patient perspectives into integration of patient perspectives into U.S.C. app. 2) and 21 CFR part 14, the regulatory process for medical the regulatory process for medical relating to advisory committees. devices. devices. It performs its duties by The PEAC provides advice on issues Dated: September 28, 2016. identifying new approaches, promoting relating to medical devices, the Janice M. Soreth, innovation, recognizing unforeseen risks regulation of devices, and their use by Acting Associate Commissioner, Special or barriers, and identifying unintended patients. A variety of topics may be Medical Programs. consequences that could result from considered by the PEAC, including [FR Doc. 2016–24100 Filed 10–4–16; 8:45 am] FDA policy. Agency guidance and policies, clinical BILLING CODE 4164–01–P FDA seeks to include the views of trial or registry design, patient women and men, members of all racial preference study design, benefit-risk and ethnic groups, and individuals with determinations, device labeling, unmet DEPARTMENT OF HEALTH AND and without disabilities on its advisory clinical needs, available alternatives, HUMAN SERVICES committees and, therefore, particularly patient reported outcomes and device- encourages nominations of related quality of life or health status Food and Drug Administration appropriately qualified candidates from issues. [Docket No. FDA–2007–D–0369] these groups. DATES: Nominations received by II. Criteria for Voting Members Product-Specific Bioequivalence November 21, 2016, will be given first The Committee consists of a core of Recommendations; Draft and Revised consideration for membership on the nine voting members including the Draft Guidances for Industry; Committee. Nominations received after Chair. Members and the Chair are Availability November 21, 2016, will be considered selected by the Commissioner of Food for nomination to the Committee as later and Drugs or designee from candidates AGENCY: Food and Drug Administration, vacancies occur. who are knowledgeable in areas such as HHS. ADDRESSES: All nominations for clinical research, primary care patient ACTION: Notice of availability. membership should be sent experience, healthcare needs of patient SUMMARY: The Food and Drug electronically by logging into the FDA groups in the United States, or are Administration (FDA or Agency) is Advisory Committee Membership experienced in the work of patient and announcing the availability of Nomination Portal: https:// health professional organizations, additional draft and revised draft www.accessdata.fda.gov/scripts/ methodologies for eliciting patient product-specific bioequivalence (BE) FACTRSPortal/FACTRS/index.cfm preferences, and strategies for recommendations. The please select Academician/Practitioner communicating benefits, risks, and recommendations provide product- in the drop down menu, to apply for clinical outcomes to patients and specific guidance on the design of BE membership, or by mail to Advisory research participants. Prospective studies to support abbreviated new drug Committee Oversight and Management members should also have an applications (ANDAs). In the Federal Staff, Food and Drug Administration, understanding of the broad spectrum of Register of June 11, 2010, FDA 10903 New Hampshire Ave., Bldg. 32, patients in a particular disease area. announced the availability of a guidance Rm. 5103, Silver Spring, MD 20993– Members will be invited to serve for for industry entitled ‘‘Bioequivalence 0002, or by FAX: 301–847–8640. overlapping terms of up to 4 years. Non- Recommendations for Specific Information about becoming a member Federal members of this Committee Products’’ that explained the process on an FDA advisory committee can also serve as Special Government that would be used to make product- be obtained by visiting FDA’s Web site Employees, with the exception of the specific BE recommendations available at http://www.fda.gov/ representatives from Industry. to the public on FDA’s Web site. The BE AdvisoryCommittees/default.htm. III. Nomination Procedures recommendations identified in this FOR FURTHER INFORMATION CONTACT: notice were developed using the process Any interested person may nominate Letise Williams, Center for Devices and one or more qualified individuals for described in that guidance. Radiological Health, Food and Drug membership on the Committee. Self- DATES: Although you can comment on Administration, 10903 New Hampshire nominations are also accepted. any guidance at any time (see 21 CFR Ave. Bldg. 66, Rm. 5441, 301–796–8398, Nominations should include a cover 10.115(g)(5)), to ensure that the Agency FAX: 301–847–8510, letter; a current, complete resume or considers your comment on this draft Letise.Williams@fda.hhs.gov. curriculum vitae for each nominee, guidance before it begins work on the SUPPLEMENTARY INFORMATION: FDA is including a current business and/or final version of the guidance, submit requesting nominations for voting home address, telephone number, and either electronic or written comments asabaliauskas on DSK3SPTVN1PROD with NOTICES members for the Committee. FDA seeks email address if available; and should on the draft guidance by December 5, to include the views of women and specify the advisory committee for 2016. men, members of all racial and ethnic which the nominee is recommended. ADDRESSES: You may submit comments groups, and individuals with and Nominations should also as follows: without disabilities on its advisory acknowledge that the nominee is aware committees and, therefore, encourages of the nomination, unless self- Electronic Submissions nominations of appropriately qualified nominated. FDA will ask potential Submit electronic comments in the candidates from these groups. candidates to provide detailed following way: VerDate Sep<11>2014 18:15 Oct 04, 2016 Jkt 241001 PO 00000 Frm 00029 Fmt 4703 Sfmt 4703 E:\FR\FM\05OCN1.SGM 05OCN1


Document Created: 2016-10-05 03:29:41
Document Modified: 2016-10-05 03:29:41
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice; request for nominations.
DatesNominations received by November 21, 2016, will be given first consideration for membership on the Committee. Nominations received after November 21, 2016, will be considered for nomination to the Committee as later vacancies occur.
ContactLetise Williams, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 66, Rm. 5441, 301-796-8398, FAX: 301-847-8510, [email protected]
FR Citation81 FR 69063 
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