Request for Notification From Consumer Organizations Interested in Participating in the Selection Process for Nominations for Voting and/or Nonvoting Consumer Representatives and Consumer Representatives on Public Advisory Committees or Panels, 7591-7593 [2012-3198]

Download as PDF 7591 Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0001] Request for Notification From Consumer Organizations Interested in Participating in the Selection Process for Nominations for Voting and/or Nonvoting Consumer Representatives and Consumer Representatives on Public Advisory Committees or Panels AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or SUMMARY: panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may either be selfnominated or may be nominated by a consumer organization. Nominations will be accepted for current vacancies and for those that will or may occur through February 2013. DATES: Any consumer organization interested in participating in the selection of an appropriate voting or nonvoting member to represent consumer interests on an FDA advisory committee or panel may send a letter or email stating that interest to FDA (see ADDRESSES) by March 14, 2012, for vacancies listed in this notice. Concurrently, nomination materials for prospective candidates should be sent to FDA (see ADDRESSES) by March 14, 2012. ADDRESSES: All statements of interest from consumer organizations interested in participating in the selection process and consumer representative nominations should be sent electronically to CV@OC.FDA.GOV, by mail to Advisory Committee Oversight and Management Staff, 10903 New Hampshire Ave., Bldg. 32, rm. 5129, Silver Spring, MD 20993–0002, or by fax to 301–847–8640. Information about becoming a member of an FDA advisory committee can be obtained by visiting FDA’s Web site at https://www.fda.gov/ AdvisoryCommittees/default.htm. FOR FURTHER INFORMATION CONTACT: Doreen Brandes, Advisory Committee Oversight and Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5122, Silver Spring, MD 20993–0002, 301– 796–8858, Doreen.Brandes@fda.hhs.gov. For questions relating to specific advisory committees or panels, contact the persons listed in table 2 in the SUPPLEMENTARY INFORMATION section of this document: FDA is requesting nominations for voting and/ or nonvoting consumer representatives for the vacancies listed in table 1 of this document: SUPPLEMENTARY INFORMATION: TABLE 1 Committee/panel/areas of expertise needed Current and upcoming vacancies Approximate date needed Allergenic Products—Knowledgeable in the field of allergenic extracts that are used for the diagnosis and treatment of allergic diseases such as allergic rhinitis (‘‘hay fever’’), allergic sinusitis, allergic conjunctivitis, bee venom allergy, and food allergy. Peripheral and Central Nervous Systems—Knowledgeable in the fields of neurology, neuropharmacology, neuropathology, otolaryngology, epidemiology or statistics, and related specialties. Non-Prescription Drugs—Knowledgeable in the fields of internal medicine, family practice, clinical toxicology, clinical pharmacology, pharmacy, dentistry, and related specialties. National Mammography Quality Assurance—Knowledgeable in clinical practice, research specialization, or professional work that has a significant focus on mammography. 1—Voting ................... 08/31/12. 1—Voting ................... 01/31/13. 1—Voting ................... 01/31/13. 2—Nonvoting ............. 01/31/13. Certain Panels of the Medical Devices Advisory Committee Clinical Chemistry and Clinical Toxicology Devices—Knowledgeable in the fields of clinical chemistry and toxicology in vitro diagnostic devices (IVDs); clinical use of related IVDs in laboratories and in home; data concerning safety and effectiveness of related IVDs for clinical use in diseases/disorders/conditions such as diabetes, cardiovascular disease, endocrine disorders, women’s health, drug abuse, therapeutic drug monitoring, and general chemistry conditions. Microbiology Devices Panel—Knowledgeable in infectious and pulmonary disease, pediatric infectious diseases, tropical diseases, and clinical microbiology. erowe on DSK2VPTVN1PROD with NOTICES A. Allergenic Products Advisory Committee The Committee reviews and evaluates available data concerning the safety, effectiveness, and adequacy of labeling of marketed and investigational allergenic biological products or materials that are administered to humans for the diagnosis, prevention, or treatment of allergies and allergic disease, and makes appropriate 14:46 Feb 10, 2012 Jkt 226001 02/28/13. 1—Voting ................... Immediately. recommendations to the Commissioner of Food and Drugs of its findings. I. Functions VerDate Mar<15>2010 1—Nonvoting ............. C. Non-Prescription Drugs Advisory Committee B. Peripheral and Central Nervous Systems Advisory Committee The Committee reviews and evaluates available data concerning the safety and effectiveness of over-the-counter (nonprescription) human drug products, or any other FDA-regulated product, for use in the treatment of a broad spectrum of human symptoms and diseases and advises the Commissioner either on the promulgation of monographs establishing conditions under which these drugs are generally recognized as The Committee reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of neurologic diseases and makes appropriate recommendations to the Commissioner of Food and Drugs. PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\FR\FM\13FEN1.SGM 13FEN1 7592 Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / Notices safe and effective and not misbranded or on the approval of new drug applications for such drugs. The Committee will serve as a forum for the exchange of views regarding the prescription and non-prescription status, including switches from one status to another, of these various drug products and combinations thereof. The Committee may also conduct peer review of Agency-sponsored intramural and extramural scientific biomedical programs in support of FDA’s mission and regulatory responsibilities. and responds to requests from the Agency to review and make recommendations on specific issues or problems concerning the safety and effectiveness of devices. With the exception of the Medical Devices Dispute Resolution Panel, each panel, according to its specialty area, may also make appropriate recommendations to the Commissioner of Food and Drugs on issues relating to the design of clinical studies regarding the safety and effectiveness of marketed and investigational devices. D. National Mammography and Quality Assurance Advisory Committee II. Criteria for Members Persons nominated for membership as consumer representatives on the committees or panels should meet the following criteria: (1) Demonstrate ties to consumer and community-based organizations, (2) be able to analyze technical data, (3) understand research design, (4) discuss benefits and risks, and (5) evaluate the safety and efficacy of products under review. The consumer representative should be able to represent the consumer perspective on issues and actions before the advisory committee; serve as a liaison between the committee and interested consumers, associations, coalitions, and consumer organizations; and facilitate dialogue with the advisory committees on scientific issues that affect consumers. The Committee reviews and evaluates (1) Developing appropriate quality standards and regulations for mammography facilities; (2) developing appropriate standards and regulations for bodies accrediting mammography facilities under this program; (3) developing regulations with respect to sanctions; (4) developing procedures for monitoring compliance with standards; (5) establishing a mechanism to investigate consumer complaints; (6) reporting new developments concerning breast imaging that should be considered in the oversight of mammography facilities; and (7) determining whether there exists a shortage of mammography facilities in rural and health professional shortage areas and determining the effects of personnel on access to the services of such facilities in such areas; (8) determining whether there will exist a sufficient number of medical physicists after October 1, 1999; and (9) determining the costs and benefits of compliance with these requirements. erowe on DSK2VPTVN1PROD with NOTICES E. Certain Panels of the Medical Devices Advisory Committee The Committee reviews and evaluates data on the safety and effectiveness of marketed and investigational devices and makes recommendations for their regulation. With the exception of the Medical Devices Dispute Resolution Panel, each panel, according to its specialty area, advises on the classification or reclassification of devices into one of three regulatory categories; advises on any possible risks to health associated with the use of devices; advises on formulation of product development protocols; reviews premarket approval applications for medical devices; reviews guidelines and guidance documents; recommends exemption of certain devices from the application of portions of the Act; advises on the necessity to ban a device; VerDate Mar<15>2010 14:46 Feb 10, 2012 Jkt 226001 III. Selection Procedures Selection of members representing consumer interests is conducted through procedures that include the use of organizations representing the public interest and public advocacy groups. These organizations recommend nominees for the Agency’s selection. Representatives from the consumer health branches of Federal, State, and local governments also may participate in the selection process. Any consumer organization interested in participating in the selection of an appropriate voting or nonvoting member to represent consumer interests should send a letter stating that interest to FDA (see ADDRESSES) within 30 days of publication of this document. Within the subsequent 30 days, FDA will compile a list of consumer organizations that will participate in the selection process and will forward to each such organization a ballot listing three to five qualified nominees selected by the Agency based on the nominations received, together with each nominee’s current curriculum vitae or resume. Ballots are to be filled out and returned to FDA within 30 days. The nominee receiving the highest number of votes PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 ordinarily will be selected to serve as the member representing consumer interests for that particular advisory committee or panel. IV. Nomination Procedures Any interested person or organization may nominate one or more qualified persons to represent consumer interests on the Agency’s advisory committees or panels. Self-nominations are also accepted. Potential candidates will be required to provide detailed information concerning such matters as financial holdings, employment, and research grants and/or contracts to permit evaluation of possible sources of conflicts of interest. All nominations should include: A cover letter; a curriculum vitae or resume that includes the nominee’s home or office address, telephone number, and email address; and a list of consumer or community-based organizations for which the candidate can demonstrate active participation. Nominations also should specify the advisory committee(s) or panel(s) for which the nominee is recommended. In addition, nominations should include confirmation that the nominee is aware of the nomination and is willing to serve as a member of the advisory committee or panel if selected. The term of office is up to 4 years. FDA will review all nominations received within the specified timeframes and prepare a ballot containing the names of three to five qualified nominees. Names not selected will remain on a list of eligible nominees and be reviewed periodically by FDA to determine continued interest. Upon selecting qualified nominees for the ballot, FDA will provide those consumer organizations that are participating in the selection process with the opportunity to vote on the listed nominees. Only organizations vote in the selection process. Persons who nominate themselves to serve as voting or nonvoting consumer representatives will not participate in the selection process. FDA has a special interest in ensuring that women, minority groups, and individuals with physical disabilities are adequately represented on its advisory committees and panels and, therefore, encourages nominations for appropriately qualified candidates from these groups. For questions relating to specific advisory committees or panels, contact the following persons listed in table 2 of this document: E:\FR\FM\13FEN1.SGM 13FEN1 7593 Federal Register / Vol. 77, No. 29 / Monday, February 13, 2012 / Notices TABLE 2 Contact person Committee/panel Donald Jehn, Center for Biologics Evaluation and Research, Food and Drug Administration, 5515 Security Lane, Rockwall Bldg. 2 (HFM–71), rm. 1118, , Rockville, MD 20852, 301–827–1293, Fax: 301–827– 0294, Donald.Jehn@fda.hhs.gov. CDR Diem-Kieu Ngo, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 2412, Silver Spring, MD 20993–0002, 301–796–9021, Fax: 301– 847–8533, Diem.Ngo@fda.hhs.gov. CDR Diem-Kieu Ngo, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 2412, Silver Spring, MD 20993–0002, 301–796–9021, Fax: 301– 847–8533, Diem.Ngo@fda.hhs.gov. LCDR Sara J. Anderson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1544, Silver Spring, MD 20993–0002, 301–796–7047, Fax: 301–847–8121, Sara.Anderson@fda.hhs.gov. LCDR Sara J. Anderson, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1544, Silver Spring, MD 20993–0002, 301–796–7047, Fax: 301–847–8121, Sara.Anderson@fda.hhs.gov. Jamie Waterhouse, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1544, Silver Spring, MD 20993–0003, 301–796–3063, Fax: 301– 847–8121, Jamie.Waterhouse@fda.hhs.gov. Shanika Craig, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1613, Silver Spring, MD 20993–0003, 301–796–6639, Fax: 301–847– 8121, Shanika.Craig@fda.hhs.gov. Dated: February 7, 2012. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2012–3198 Filed 2–10–12; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Comment Request In compliance with the requirement for opportunity for public comment on proposed data collection projects (section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104–13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email paperwork@hrsa.gov or call the HRSA Reports Clearance Officer at (301) 443– 0165. Comments are invited on: (a) The proposed collection of information for the proper performance of the functions of the Agency; (b) the accuracy of the Agency’s estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques Allergenic Products. Peripheral and Central Nervous Systems Drugs. Non-Prescription Drugs. National Mammography and Quality Assurance. Clinical Chemistry and Toxicology Devices. Clinical Ear, Nose, and Throat Devices. Microbiology Devices Panel. or other forms of information technology. Proposed Project: Uncompensated Services Assurance Report (OMB No. 0915–0077)—[Extension] Under the Hill-Burton Act, the Government provides grants and loans for construction or renovation of health care facilities. As a condition of receiving this construction assistance, facilities are required to provide services to persons unable to pay. A condition of receiving this assistance requires facilities to provide periodic assurances that the required level of uncompensated care is being provided, and that certain notification and record keeping procedures are being followed. These standard requirements are referred to as the uncompensated services assurance. The annual estimate of burden is as follows: ESTIMATE OF INFORMATION COLLECTION BURDEN Number of respondents Type of requirement and regulatory citation Responses per respondent Total responses Hours per response Total burden hours 63 63 63 1 1 63 63 63 3,969 0.75 43.60 0.75 47.25 2,746.80 2,976.75 SUBTOTAL DISCLOSURE BURDEN ................... erowe on DSK2VPTVN1PROD with NOTICES Disclosure Burden (42 CFR): Published Notices (124.504(c)) .................................... Individual Notices (124.504(c)) ..................................... Determinations of Eligibility (124.507) ................................. ........................ ........................ ........................ ........................ 5,770.80 Number of respondents Responses per respondent Total responses Hours per response Type of requirement and regulatory citation Reporting: Uncompensated Services Report—HRSA–710 Form (124.509(a)) ............................................................... VerDate Mar<15>2010 14:46 Feb 10, 2012 Jkt 226001 PO 00000 Frm 00029 10 Fmt 4703 Sfmt 4703 1 E:\FR\FM\13FEN1.SGM 10 13FEN1 11.00 Total burden hours 110.00

Agencies

[Federal Register Volume 77, Number 29 (Monday, February 13, 2012)]
[Notices]
[Pages 7591-7593]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-3198]

[[Page 7591]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]

Request for Notification From Consumer Organizations Interested
in Participating in the Selection Process for Nominations for Voting
and/or Nonvoting Consumer Representatives and Consumer Representatives
on Public Advisory Committees or Panels

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is requesting that any
consumer organizations interested in participating in the selection of
voting and/or nonvoting consumer representatives to serve on its
advisory committees or panels notify FDA in writing. FDA is also
requesting nominations for voting and/or nonvoting consumer
representatives to serve on advisory committees and/or panels for which
vacancies currently exist or are expected to occur in the near future.
Nominees recommended to serve as a voting or nonvoting consumer
representative may either be self-nominated or may be nominated by a
consumer organization. Nominations will be accepted for current
vacancies and for those that will or may occur through February 2013.

DATES: Any consumer organization interested in participating in the
selection of an appropriate voting or nonvoting member to represent
consumer interests on an FDA advisory committee or panel may send a
letter or email stating that interest to FDA (see ADDRESSES) by March
14, 2012, for vacancies listed in this notice. Concurrently, nomination
materials for prospective candidates should be sent to FDA (see
ADDRESSES) by March 14, 2012.

ADDRESSES: All statements of interest from consumer organizations
interested in participating in the selection process and consumer
representative nominations should be sent electronically to
CV@OC.FDA.GOV, by mail to Advisory Committee Oversight and Management
Staff, 10903 New Hampshire Ave., Bldg. 32, rm. 5129, Silver Spring, MD
20993-0002, or by fax to 301-847-8640. Information about becoming a
member of an FDA advisory committee can be obtained by visiting FDA's
Web site at https://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT: Doreen Brandes, Advisory Committee
Oversight and Management Staff, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, rm. 5122, Silver Spring, MD 20993-0002, 301-
796-8858, Doreen.Brandes@fda.hhs.gov.
For questions relating to specific advisory committees or panels,
contact the persons listed in table 2 in the SUPPLEMENTARY INFORMATION
section of this document:

SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting
and/or nonvoting consumer representatives for the vacancies listed in
table 1 of this document:

Table 1
----------------------------------------------------------------------------------------------------------------
Committee/panel/areas of expertise
needed Current and upcoming vacancies Approximate date needed
----------------------------------------------------------------------------------------------------------------
Allergenic Products--Knowledgeable in 1--Voting.......................... 08/31/12.
the field of allergenic extracts that
are used for the diagnosis and
treatment of allergic diseases such
as allergic rhinitis (``hay fever''),
allergic sinusitis, allergic
conjunctivitis, bee venom allergy,
and food allergy.
Peripheral and Central Nervous 1--Voting.......................... 01/31/13.
Systems--Knowledgeable in the fields
of neurology, neuropharmacology,
neuropathology, otolaryngology,
epidemiology or statistics, and
related specialties.
Non-Prescription Drugs--Knowledgeable 1--Voting.......................... 01/31/13.
in the fields of internal medicine,
family practice, clinical toxicology,
clinical pharmacology, pharmacy,
dentistry, and related specialties.
National Mammography Quality 2--Nonvoting....................... 01/31/13.
Assurance--Knowledgeable in clinical
practice, research specialization, or
professional work that has a
significant focus on mammography.
----------------------------------------------------------------------------------------------------------------
Certain Panels of the Medical Devices Advisory Committee
----------------------------------------------------------------------------------------------------------------
Clinical Chemistry and Clinical 1--Nonvoting....................... 02/28/13.
Toxicology Devices--Knowledgeable in
the fields of clinical chemistry and
toxicology in vitro diagnostic
devices (IVDs); clinical use of
related IVDs in laboratories and in
home; data concerning safety and
effectiveness of related IVDs for
clinical use in diseases/disorders/
conditions such as diabetes,
cardiovascular disease, endocrine
disorders, women's health, drug
abuse, therapeutic drug monitoring,
and general chemistry conditions.
Microbiology Devices Panel-- 1--Voting.......................... Immediately.
Knowledgeable in infectious and
pulmonary disease, pediatric
infectious diseases, tropical
diseases, and clinical microbiology.
----------------------------------------------------------------------------------------------------------------

I. Functions

A. Allergenic Products Advisory Committee

The Committee reviews and evaluates available data concerning the
safety, effectiveness, and adequacy of labeling of marketed and
investigational allergenic biological products or materials that are
administered to humans for the diagnosis, prevention, or treatment of
allergies and allergic disease, and makes appropriate recommendations
to the Commissioner of Food and Drugs of its findings.

B. Peripheral and Central Nervous Systems Advisory Committee

The Committee reviews and evaluates data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of neurologic diseases and makes appropriate
recommendations to the Commissioner of Food and Drugs.

C. Non-Prescription Drugs Advisory Committee

The Committee reviews and evaluates available data concerning the
safety and effectiveness of over-the-counter (non-prescription) human
drug products, or any other FDA-regulated product, for use in the
treatment of a broad spectrum of human symptoms and diseases and
advises the Commissioner either on the promulgation of monographs
establishing conditions under which these drugs are generally
recognized as

[[Page 7592]]

safe and effective and not misbranded or on the approval of new drug
applications for such drugs. The Committee will serve as a forum for
the exchange of views regarding the prescription and non-prescription
status, including switches from one status to another, of these various
drug products and combinations thereof. The Committee may also conduct
peer review of Agency-sponsored intramural and extramural scientific
biomedical programs in support of FDA's mission and regulatory
responsibilities.

D. National Mammography and Quality Assurance Advisory Committee

The Committee reviews and evaluates (1) Developing appropriate
quality standards and regulations for mammography facilities; (2)
developing appropriate standards and regulations for bodies accrediting
mammography facilities under this program; (3) developing regulations
with respect to sanctions; (4) developing procedures for monitoring
compliance with standards; (5) establishing a mechanism to investigate
consumer complaints; (6) reporting new developments concerning breast
imaging that should be considered in the oversight of mammography
facilities; and (7) determining whether there exists a shortage of
mammography facilities in rural and health professional shortage areas
and determining the effects of personnel on access to the services of
such facilities in such areas; (8) determining whether there will exist
a sufficient number of medical physicists after October 1, 1999; and
(9) determining the costs and benefits of compliance with these
requirements.

E. Certain Panels of the Medical Devices Advisory Committee

The Committee reviews and evaluates data on the safety and
effectiveness of marketed and investigational devices and makes
recommendations for their regulation. With the exception of the Medical
Devices Dispute Resolution Panel, each panel, according to its
specialty area, advises on the classification or reclassification of
devices into one of three regulatory categories; advises on any
possible risks to health associated with the use of devices; advises on
formulation of product development protocols; reviews premarket
approval applications for medical devices; reviews guidelines and
guidance documents; recommends exemption of certain devices from the
application of portions of the Act; advises on the necessity to ban a
device; and responds to requests from the Agency to review and make
recommendations on specific issues or problems concerning the safety
and effectiveness of devices. With the exception of the Medical Devices
Dispute Resolution Panel, each panel, according to its specialty area,
may also make appropriate recommendations to the Commissioner of Food
and Drugs on issues relating to the design of clinical studies
regarding the safety and effectiveness of marketed and investigational
devices.

II. Criteria for Members

Persons nominated for membership as consumer representatives on the
committees or panels should meet the following criteria: (1)
Demonstrate ties to consumer and community-based organizations, (2) be
able to analyze technical data, (3) understand research design, (4)
discuss benefits and risks, and (5) evaluate the safety and efficacy of
products under review. The consumer representative should be able to
represent the consumer perspective on issues and actions before the
advisory committee; serve as a liaison between the committee and
interested consumers, associations, coalitions, and consumer
organizations; and facilitate dialogue with the advisory committees on
scientific issues that affect consumers.

III. Selection Procedures

Selection of members representing consumer interests is conducted
through procedures that include the use of organizations representing
the public interest and public advocacy groups. These organizations
recommend nominees for the Agency's selection. Representatives from the
consumer health branches of Federal, State, and local governments also
may participate in the selection process. Any consumer organization
interested in participating in the selection of an appropriate voting
or nonvoting member to represent consumer interests should send a
letter stating that interest to FDA (see ADDRESSES) within 30 days of
publication of this document.
Within the subsequent 30 days, FDA will compile a list of consumer
organizations that will participate in the selection process and will
forward to each such organization a ballot listing three to five
qualified nominees selected by the Agency based on the nominations
received, together with each nominee's current curriculum vitae or
resume. Ballots are to be filled out and returned to FDA within 30
days. The nominee receiving the highest number of votes ordinarily will
be selected to serve as the member representing consumer interests for
that particular advisory committee or panel.

IV. Nomination Procedures

Any interested person or organization may nominate one or more
qualified persons to represent consumer interests on the Agency's
advisory committees or panels. Self-nominations are also accepted.
Potential candidates will be required to provide detailed information
concerning such matters as financial holdings, employment, and research
grants and/or contracts to permit evaluation of possible sources of
conflicts of interest.
All nominations should include: A cover letter; a curriculum vitae
or resume that includes the nominee's home or office address, telephone
number, and email address; and a list of consumer or community-based
organizations for which the candidate can demonstrate active
participation.
Nominations also should specify the advisory committee(s) or
panel(s) for which the nominee is recommended. In addition, nominations
should include confirmation that the nominee is aware of the nomination
and is willing to serve as a member of the advisory committee or panel
if selected. The term of office is up to 4 years.
FDA will review all nominations received within the specified
timeframes and prepare a ballot containing the names of three to five
qualified nominees. Names not selected will remain on a list of
eligible nominees and be reviewed periodically by FDA to determine
continued interest. Upon selecting qualified nominees for the ballot,
FDA will provide those consumer organizations that are participating in
the selection process with the opportunity to vote on the listed
nominees. Only organizations vote in the selection process. Persons who
nominate themselves to serve as voting or nonvoting consumer
representatives will not participate in the selection process.
FDA has a special interest in ensuring that women, minority groups,
and individuals with physical disabilities are adequately represented
on its advisory committees and panels and, therefore, encourages
nominations for appropriately qualified candidates from these groups.
For questions relating to specific advisory committees or panels,
contact the following persons listed in table 2 of this document:

[[Page 7593]]

Table 2
----------------------------------------------------------------------------------------------------------------
Contact person Committee/panel
----------------------------------------------------------------------------------------------------------------
Donald Jehn, Center for Biologics Evaluation and Research, Food and Drug Allergenic Products.
Administration, 5515 Security Lane, Rockwall Bldg. 2 (HFM-71), rm. 1118, ,
Rockville, MD 20852, 301-827-1293, Fax: 301-827-0294,
Donald.Jehn@fda.hhs.gov.
CDR Diem-Kieu Ngo, Center for Drug Evaluation and Research, Food and Drug Peripheral and Central Nervous
Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 2412, Silver Systems Drugs.
Spring, MD 20993-0002, 301-796-9021, Fax: 301-847-8533,
Diem.Ngo@fda.hhs.gov.
CDR Diem-Kieu Ngo, Center for Drug Evaluation and Research, Food and Drug Non-Prescription Drugs.
Administration, 10903 New Hampshire Ave., Bldg. 31, rm. 2412, Silver
Spring, MD 20993-0002, 301-796-9021, Fax: 301-847-8533,
Diem.Ngo@fda.hhs.gov.
LCDR Sara J. Anderson, Center for Devices and Radiological Health, Food and National Mammography and Quality
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1544, Silver Assurance.
Spring, MD 20993-0002, 301-796-7047, Fax: 301-847-8121,
Sara.Anderson@fda.hhs.gov.
LCDR Sara J. Anderson, Center for Devices and Radiological Health, Food and Clinical Chemistry and Clinical
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1544, Silver Toxicology Devices.
Spring, MD 20993-0002, 301-796-7047, Fax: 301-847-8121,
Sara.Anderson@fda.hhs.gov.
Jamie Waterhouse, Center for Devices and Radiological Health, Food and Drug Ear, Nose, and Throat Devices.
Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1544, Silver
Spring, MD 20993-0003, 301-796-3063, Fax: 301-847-8121,
Jamie.Waterhouse@fda.hhs.gov.
Shanika Craig, Center for Devices and Radiological Health, Food and Drug Microbiology Devices Panel.
Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1613, Silver
Spring, MD 20993-0003, 301-796-6639, Fax: 301-847-8121,
Shanika.Craig@fda.hhs.gov.
----------------------------------------------------------------------------------------------------------------

Dated: February 7, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-3198 Filed 2-10-12; 8:45 am]
BILLING CODE 4160-01-P

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