Document ID: FDA-2010-N-0001-0032
Agency: fda
Document Type: Rule
Title: Advisory Committees; Technical Amendment
Posted Date: 2010-03-29T04:00Z

[Federal Register: March 29, 2010 (Volume 75, Number 59)]
[Rules and Regulations]               
[Page 15342-15343]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29mr10-7]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 14

[Docket No. FDA-2010-N-0001]

 
Advisory Committees; Technical Amendment

Agency: Food and Drug Administration, HHS.

ACTION:  Final rule; technical amendment.

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SUMMARY:  The Food and Drug Administration (FDA) is amending its 
regulations on public hearings before public advisory committees to 
reflect an internal change with respect to the staff that handles the 
nomination and selection process for nonvoting members representing 
consumer interests for standing technical advisory committees. FDA is 
also revising the address where the nominations for nonvoting members 
representing consumer interests should be submitted.

DATES: This rule is effective March 29, 2010.

FOR FURTHER INFORMATION CONTACT:  Dornette D. Spell LeSane, Advisory 
Committee Oversight and Management Staff, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 32, rm. 5103, Silver Spring, MD 20993, 
301-796-8220.

SUPPLEMENTARY INFORMATION: FDA is amending its regulations in part 14 
(21 CFR part 14) to clarify that the Advisory Committee Oversight and 
Management Staff (ACOMS), within FDA's Office of the Commissioner, now 
coordinates the nomination and selection process for nonvoting members 
representing consumer interests for standing technical advisory 
committees. The amendments also change the address where interested 
persons should submit nominations for those nonvoting members. This 
document makes the appropriate changes to Sec.  14.84(c).
    Publication of this document constitutes final action on these 
changes under the Administrative Procedure Act (5 U.S.C. 553). FDA has 
determined that notice and public comment are unnecessary because this 
amendment to the regulations provides only technical changes.

List of Subjects in 21 CFR Part 14

    Administrative practice and procedure, Advisory committees, Color 
additives, Drugs, Radiation protection.

0
Therefore, under authority delegated to the Commissioner of Food and 
Drugs, 21 CFR part 14 is amended as follows:

PART 14--PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE

0
1. The authority citation for part 14 continues to read as follows:

    Authority: 5 U.S.C. App. 2; 15 U.S.C. 1451-1461, 21 U.S.C. 41-
50, 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 
U.S.C. 201, 262, 263b 264; Pub. L. 107-109; Pub. L. 108-155.

0
2. Section 14.84 is amended by revising paragraphs (c)(1), (c)(3), 
(c)(4), and (c)(5)(ii) to read as follows:

Sec.  14.84   Nominations and selection of nonvoting members of 
standing technical advisory committees.

* * * * *
    (c) * * *
    (1) A period of 30 days will be permitted for submission of 
nominations for that committee or subcommittee. Interested persons may 
nominate one or more qualified persons to represent consumer interests. 
Although nominations from individuals

[[Page 15343]]

will be accepted, individuals are encouraged to submit their 
nominations through consumer organizations as defined in paragraph 
(c)(3) of this section. Nominations of qualified persons for general 
consideration as nonvoting members of unspecified advisory committees 
or subcommittees may be made at any time. All nominations are to be 
submitted in writing to Advisory Committee Oversight and Management 
Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
32, rm. 1503, Silver Spring, MD 20993.
* * * * *
    (3) The Advisory Committee Oversight and Management Staff will 
compile a list of organizations whose objectives are to promote, 
encourage, and contribute to the advancement of consumer education and 
to the resolution of consumer problems. All organizations listed are 
entitled to vote upon the nominees. The list will include organizations 
representing the public interest, consumer advocacy groups, and 
consumer/health branches of Federal, State, and local governments. Any 
organization that meets the criteria may be included on such list on 
request.
    (4) The executive secretary, or other designated agency employee, 
will review the list of nominees and select three to five qualified 
nominees to be placed on a ballot. Names not selected will remain on a 
list of eligible nominees and be reviewed periodically by the Advisory 
Committee Oversight and Management Staff to determine continued 
interest. Upon selection of the nominees to be placed on the ballot, 
the curriculum vitae for each of the nominees will be sent to each of 
the organizations on the list complied under paragraph (c)(3) of this 
section, together with a ballot to be filled out and returned within 30 
days. After the time for return of the ballots has expired, the ballots 
will be counted and the nominee who has received the highest number of 
votes will be selected as the nonvoting member representing consumer 
interests for that particular advisory committee or subcommittee. In 
the event of a tie, the Commissioner will select the winner by lot from 
among those tied for the highest number of votes
    (5) * * *
    (ii) If none of the nominees on the original ballot is willing to 
serve, or if there was only one nominee on the original ballot, the 
Advisory Committee Oversight and Management Staff will contact by 
telephone eligible individuals whose names have been submitted in the 
past as candidates for membership as representatives of consumer 
interests. A list of persons who are interested in serving on an 
advisory committee will then be prepared. The curricula vitae of these 
persons, together with a ballot, will be sent to a representative 
number of consumer organizations that have been determined to be 
eligible to vote for consumer representatives in accordance with 
paragraph (c)(3) of this section. After 4 days have elapsed, the 
Advisory Committee Oversight and Management Staff will contact the 
consumer organizations by telephone and elicit their votes. The 
candidate who has received the highest number of votes will be 
selected. In the event of a tie, the Commissioner will select the 
winner by lot from among those tied for the highest number of votes.
* * * * *

    Dated: March 23, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-6861 Filed 3-26-10; 8:45 am]
BILLING CODE 4160-01-S