[Federal Register Volume 69, Number 147 (Monday, August 2, 2004)]
[Notices]
[Pages 46151-46152]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-17541]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Request for Nominations for Voting and Nonvoting Members on a 
Public Advisory Committee; Pediatric Advisory Committee

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is requesting 
nominations for members to serve on the Pediatric Advisory Committee in 
the Office of the Commissioner. Elsewhere in this issue of the Federal 
Register, FDA is publishing a document announcing the establishment of 
this committee.
    FDA has special interest in ensuring that women, minority groups, 
and individuals with disabilities are adequately represented on 
advisory committees and, therefore, encourages nominations of qualified 
candidates from these groups.

DATES:  Nominations received on or before August 17, 2004 will be given 
first consideration for membership on the Pediatric Advisory Committee. 
Nominations received after August 17, 2004 will be considered for 
nomination to the Pediatric Advisory Committee should nominees still be 
needed.

ADDRESSES:  All nominations for membership, except for the consumer 
member, and the member from a patient or patient-family organization, 
should be sent to Jan Johannessen, Office of Science and Health 
Coordination (HF-33), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, e-mail: [email protected].
     All nominations for the consumer member should be sent to Michael 
F. Ortwerth, Office of the Commissioner (HF-4), Food and Drug 
Administration, 5600 Fishers Lane, Rockville 20857, e-mail: 
[email protected].
    All nominations for the patient or patient-family member should be 
sent to M. Lyvon Covington, Office of Special Health Issues (HF-12), 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 
e-mail: [email protected].

FOR FURTHER INFORMATION CONTACT:  Regarding all nomination questions 
for membership, the primary contact is Jan N. Johannessen, Office of 
Science and Health Coordination (HF-33), Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857, 301-827-6687 or FAX: 301-827-
3042.

SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting and 
nonvoting members on the Pediatric Advisory Committee.

I. Function of the Pediatric Advisory Committee

    The committee advises the Commissioner of Food and Drugs on 
pediatric therapeutics, pediatric research, and other matters involving 
pediatrics for which the Food and Drug Administration has regulatory 
responsibility. The Committee will also

[[Page 46152]]

advise and make recommendations to the Secretary of Health and Human 
Services pursuant to 45 CFR 46.407 on research involving children as 
subjects that is conducted or supported by the Department of Health and 
Human Services.

II. Criteria for Voting Members

    1. Research and Clinical Scientists: Persons nominated for 
membership shall have scientific expertise in one or more of the 
following disciplines: Pediatric research, pediatric sub-specialties, 
pediatric therapeutics, statistics, and/or biomedical ethics.
    2. Consumer Member: Persons nominated for membership on the 
committee as a consumer member shall have the following: (1) Ties to a 
consumer and/or community-based organization, (2) ability to analyze 
technical data, (3) understanding of research design, (4) ability to 
discuss benefits and risks, and (5) ability to evaluate the safety and 
efficacy of products under review. In their individual capacity, the 
consumer member will have the responsibility of representing the 
consumer perspective on issues and actions before the advisory 
committee; serving as a liaison between the committee and interested 
consumers, associations, coalitions, and consumer organizations; and 
facilitating dialogue with the advisory committee on scientific issues 
that affect consumers.
    3. Patient or Patient-Family Organization Member: Persons nominated 
for membership on the committee as a patient or patient-family 
organization member shall have the following: (1) Personal experience 
with a specific pediatric disease as a patient or patient care-giver; 
(2) experience in patient advocacy; (3) ability to communicate the 
interests and perspectives of patients; (4) ability to understand 
scientific data and technical information about research studies, and/
or personal experience as a participant in clinical research; and (5) 
ability to disseminate information about the advisory committee 
experience to the patient community. As a member of the Pediatric 
Advisory Committee, the patient or patient-family organization member 
will serve in their individual capacity.

III. Criteria for Nonvoting Members

    1. Industry Representative: Persons nominated for membership on the 
committee as a nonvoting industry representative shall have the 
following: (1) Professional experience in the medical product regulated 
industry, (2) ability to understand and analyze scientific data and 
issues related to pediatric product development, and (3) ability to 
communicate and disseminate information about the advisory committee 
experience to interested parties of industry.
    2. Pediatric Health Organization Representative: Persons nominated 
for membership on the committee as a representative from a pediatric 
health organization shall have the following: (1) A direct affiliation 
with a recognized pediatric health organization and (2) the ability to 
understand and analyze scientific data and technical information.

IV. Nomination Procedures

    1. Research and Clinical Scientists: Any interested person may 
nominate one or more qualified persons for membership on the advisory 
committee. Self-nominations are also accepted. Nominations shall 
include a current resume or curriculum vitae of each nominee, including 
current business address and telephone number, and shall state that the 
nominee is aware of the nomination, is willing to serve as a member, 
and appears to have no conflict of interest that would preclude 
membership. FDA will ask the potential candidates to provide detailed 
information concerning matters related to financial holdings, 
employment, and research grants and/or contracts.
    2. Consumer Member: Any interested person or organization may 
nominate one or more qualified persons for membership on the pediatric 
advisory committee to represent consumer interests. Self-nominations 
are also accepted.
    All nominations must include a cover letter, a curriculum vitae or 
resume, including current business address and telephone number and a 
list of consumer or community-based organizations for which the 
candidate can demonstrate active participation. FDA will ask the 
potential candidates to provide detailed information concerning matters 
related to financial holdings, employment, and research grants and/or 
contracts.
    Selection of members representing consumer interests is conducted 
through procedures that include the use of organizations representing 
public interest and consumer advocacy groups. The organizations have 
the responsibility of recommending candidates to the agency for 
selection.
    3. Patient or Patient-Family Organization Member: Individuals, 
patient advocacy groups and organizations may submit nominations. Self-
nominations will also be accepted.
    Nominations shall include a current resume of the nominee 
(including current contact information), shall state that the nominee 
is aware of the nomination, is willing to serve as a member, and 
appears to have no conflict of interest that would preclude membership. 
FDA will ask the potential candidates to provide detailed information 
concerning matters related to potential financial interests.
    4. Pediatric Health Organization Representative: Individuals and 
pediatric organizations may submit nominations. Self-nominations will 
also be accepted.
    All nominations must include a cover letter, a curriculum vitae or 
resume, information delineating the mission of the pediatric health 
organization and the relationship of the nominee to the pediatric 
health organization.
    5. Industry Representative: Interested persons may nominate one or 
more qualified persons for membership. Self-nominations are also 
accepted.
    Nominations shall include a current resume or curriculum vitae of 
each nominee, including current business address and telephone number, 
and shall state that the nominee is aware of the nomination, and is 
willing to serve as a nonvoting member. Nominees must have demonstrated 
first hand knowledge or work experience of the industry. Nominees must 
also demonstrate that they have the mechanisms to disseminate 
information from the advisory committee experience to their 
constituents.
    Selection of the member representing industry interests will be 
made in accordance with 21 CFR 14.84(d). Any organization wishing to 
participate in the selection of a nonvoting member to represent 
industry on the Pediatric Advisory Committee should send a letter 
stating that interest to the FDA contact identified previously within 
30 days of publication of this notice. Individuals who nominate 
themselves as industry 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: July 27, 2004.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 04-17541 Filed 7-29-04; 10:30 am]
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