[Federal Register: August 2, 2004 (Volume 69, Number 147)]
[Notices]
[Page 46151-46152]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02au04-49]
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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: jjohannessen@fda.gov.
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:
michael.ortwerth@fda.hhs.gov.
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: Magdalene.Covington@fda.hhs.gov.
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
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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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