Office Of Special Medical Pro

Consumer Representative Mem

CDR Dornette Spell-LeSane, MHA, MSN, NP-C

Deputy Director, ACOMS

Rockville, MD

30 April 2010

E- mail address is dornette.spelllesane @ fda.hhs.gov
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Consumer Representative Nomina

Major points to remembe

1. Track the federal register notices 

nominations for each specific com

2. Submit nominations3. Consumer groups may submit req

participate in the nomination proc

4. Consumer Groups participating, r
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Consumer Representative Nomination P

21 CFR Sec. 14.84 (a)(1)-(5)Nominations and selection of nonvoting members o

technical advisory committees.At least 6 months in advance of future vacancies a nominations of voting and non-voting members of Fcommittees is initiated by the Designated Federal Oadvisory committee.
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Consumer Representative Nomination P

Federal Register Announcement

21 CFR Sec. 14.84(b) members are normally limited to one person seleconsumer groups and organizations (c) To select a nonvoting member to represent cons

the Commissioner publishes a notice in the Federal requesting nominations for each specific committeesubcommittee, for which nonvoting members are to also applies to voting representatives

Federal register notice can be found on the FDA AC whttp://www.fda.gov/AdvisoryCommittees/default.htm
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Consumer Representative Nomination P

Submit Nomination

21 CFR Sec. 14.84(1)

A period of 30 days will be permitted for submission of nomicommittee or subcommittee. Interested persons may nominqualified persons to represent consumer interests. 

•Although nominations from individuals will be acceptedencouraged to submit their nominations through consum•Nominations of qualified persons for general consideraany time. •All nominations are to be submitted in writing to the AdOversight and Management Staff 

White Oak Building 32, Rm 5129 10903 New Hampshire Ave Silver Spring Md 20993

E mail: CV@OC.fda.gov
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Consumer Representative Nomination P

Submit Nomination

21 CFR Sec. 14.84(2)

A complete curriculum vitae of any nominee is to be includeNominations must include:

•Nominees name (complete contact information)•Name of committee of interest 

Recommend:•A letter of recommendation •state that the nominee is aware of the nomination and willi

•Cover letter that includes the consumer or community basorganization(s) OR work which the candidate can demonstparticipation 
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Consumer Representative Nomination P

Consumer Group Participation

21 CFR Sec. 14.84(3)

The Advisory Committee Oversight and Managem• will compile a list of organizations whose objectiv

promote, encourage, and contribute to the advanceconsumer education and to the resolution of consu•All organizations listed are entitled to vote upon th

•The list will include organizations representing the consumer advocacy groups, and consumer/health Federal, State, and local governments. •Any organization that meets the criteria may be in

list on request.
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Consumer Representative Nomination P

Designated Federal Officer

21 CFR Sec. 14.84(4)

The executive secretary (DFO), will review the list of 

select three to five qualified nominees to be placed o

• Names not selected will remain on a list of eligible n

reviewed periodically by ACOMS to determine contin

• Upon selection of the nominees to be placed on the 

curriculum vitae for each of the nominees will be senorganizations on the list together with a ballot to be freturned within 30 days. 

• After the time for return of the ballots has expired, th

counted and the nominee who has received the highvotes will be selected as the member representing cinterests for that particular advisory committee
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Consumer Representative Nomination P

Resignations

21 CFR Sec. 14.84(5)

If a member representing consumer interests resign

before termination of the committee on which the methe following procedures will be used to appoint a reout the term of the former member:(i) The Commissioner will appoint the runner up, in oballots received, on the original ballot submitted to fithe runner up is no longer willing to serve as a memrunner up will be appointed.
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Consumer Representative Nomination P

Resignations

21 CFR Sec. 14.84(5)

(ii) If none of the nominees on the original ballot is there was only one nominee on the original ballotby telephone eligible individuals whose names hathe past as candidates for membership as represeconsumer interests. 

• The curricula vitae of these persons, together with 

to a representative number of consumer organizadetermined to be eligible to vote for consumer rep

• After 4 days have elapsed, ACOMS will contact th

organizations by telephone and elicit their votes. Thas received the highest number of votes will be s
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Consumer Representative Nomination P

Consumer Group Participation

1. Groups respond to the Federal register 2. Groups Submit Nominations3. Include a statement that the group is re

participate in the nomination process (in

name and contact information of the po

4. The group will receive each nominees’ 

information that includes a CV, recommletter, ballot

5. Groups must return the ballot6. ACOMS will notify group and individual
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FDA Advisory Committees Ne

Thank you