Request for Nominations for Individuals and Consumer Organizations for Advisory Committees, 18235-18238 [2015-07605]

Download as PDF Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Notices trading in a range from 0 to 1⁄4 percent. The Committee directs the Desk to undertake open market operations as necessary to maintain such conditions. The Committee directs the Desk to maintain its policy of rolling over maturing Treasury securities into new issues and its policy of reinvesting principal payments on all agency debt and agency mortgage-backed securities in agency mortgage-backed securities. The Committee also directs the Desk to engage in dollar roll and coupon swap transactions as necessary to facilitate settlement of the Federal Reserve’s agency mortgage-backed securities transactions. The System Open Market Account manager and the secretary will keep the Committee informed of ongoing developments regarding the System’s balance sheet that could affect the attainment over time of the Committee’s objectives of maximum employment and price stability. By order of the Federal Open Market Committee, March 24, 2015. Thomas Laubach, Secretary, Federal Open Market Committee. [FR Doc. 2015–07708 Filed 4–2–15; 8:45 am] BILLING CODE 6210–01–P FEDERAL RESERVE SYSTEM asabaliauskas on DSK5VPTVN1PROD with NOTICES Formations of, Acquisitions by, and Mergers of Bank Holding Companies The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below. The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States. VerDate Sep<11>2014 17:49 Apr 02, 2015 Jkt 235001 Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than April 30, 2015. A. Federal Reserve Bank of Chicago (Colette A. Fried, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690–1414: 1. Foresight Financial Group, Inc., Rockford, Illinois; to acquire 100 percent of the voting shares of State Bank of Herscher, Herscher, Illinois. 18235 information collection and has assigned OMB control number 0910–0783. The approval expires on March 31, 2018. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. Dated: March 30, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–07655 Filed 4–2–15; 8:45 am] BILLING CODE 4164–01–P Board of Governors of the Federal Reserve System, March 31, 2015. Michael J. Lewandowski, Associate Secretary of the Board. DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2015–07663 Filed 4–2–15; 8:45 am] Food and Drug Administration BILLING CODE 6210–01–P [Docket No. FDA–2015–N–0001] DEPARTMENT OF HEALTH AND HUMAN SERVICES Request for Nominations for Individuals and Consumer Organizations for Advisory Committees Food and Drug Administration AGENCY: [Docket No. FDA–2011–F–0172] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled, ‘‘Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments,’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: On February 5, 2015, the Agency submitted a proposed collection of information entitled ‘‘Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the SUMMARY: PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 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 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 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 September 30, 2015. 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 the FDA (see ADDRESSES) by May 4, 2015, for vacancies listed in this notice. Concurrently, nomination materials for prospective candidates should be sent to FDA (see ADDRESSES) by May 4, 2015. ADDRESSES: All statements of interest from consumer organizations interested in participating in the selection process and consumer representative nominations should submit your information electronically to SUMMARY: E:\FR\FM\03APN1.SGM 03APN1 18236 Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Notices kimberly.hamilton@fda.hhs.gov or by mail to Advisory Committee Oversight and Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993–0002, or FAX: 301–847–8640. Consumer Representative nominations should be submitted electronically by logging into the FDA advisory Committee Membership Nomination Portal: https:// www.accessdata.fda.gov/scripts/ FACTRSPortal/FACTRS/index.cfm or by mail to Advisory Committee Oversight and Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993–0002, or FAX: 301–847–8640. Additional information about becoming a member on an FDA advisory committee can also be obtained by visiting FDA’s Web site at https:// www.fda.gov/AdvisoryCommittees/ default.htm. FOR FURTHER INFORMATION CONTACT: Kimberly Hamilton, Advisory Committee Oversight and Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5117, Silver Spring, MD 20993– 0002;. 301–796–8224, email: kimberly.hamilton@fda.hhs.gov. For questions relating to specific advisory committees or panels, contact the following persons listed in table 1 of this document: TABLE 1—ADVISORY COMMITTEE CONTACTS Contact person Committee/Panel Janie Kim, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6129, Silver Spring, MD 20993; 301–796–9016, email: Janie.Kim@fda.hhs.gov. Stephanie Begansky, Center for Drug Evaluation and Research, Division of Advisory Committee and Consultant Management, Office of Executive Programs, 10903 New Hampshire Ave., Bldg. 31, Rm. 2426, Silver Spring, MD 20993–0002; 301–796–3693, FAX: 301–847– 8533, email: Stephanie.Begansky@fda.hhs.gov. Jamie Waterhouse, Center for Devices and Radiological Health, Office of Device Evaluation, 10903 New Hampshire Ave., Bldg. 66, Rm. 1544, Silver Spring, MD 20993–0002; 301–796– 3063, FAX: 301–847–8122, email: Jamie.Waterhouse@fda.hhs.gov. Yvette Waples, Center for Drug Evaluation & Research, Division of Advisory Committee and Consultant Management, Office of Executive Programs, 10993 New Hampshire Ave., Bldg. 31, Rm. 2510, Silver Spring, MD 20993–0002; 301–796–9034 FAX: 301–847–8533 email: Yvette.Waples@fda.hhs.gov. Patricio Garcia, Center for Devices and Radiological Health, Office of Device Evaluation, 10903 New Hampshire Ave., Bldg. 66, Rm. RMG 465 HFZ–410, Silver Spring, MD 20903–0002, 301–796–6875, FAX: 301–847–8120, email: Patricio.Garcia@fda.hhs.gov. Sara J. Anderson, Center for Devices and Radiological Health, Office of Device Evaluation, 10903 New Hampshire Ave., Bldg. 66, Rm. 1544, Silver Spring, MD 20903–0002; 301–796– 7047, FAX: 301–847–8122, email: Sara.Anderson@fda.hhs.gov. Shanika Craig, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66 Rm. 1613, Silver Spring, MD 20993–0002; 301–796–6639, FAX: 301–847–8120, email: Shanika.Craig@fda.hhs.gov. Lauren Tesh, Center for Drug Evaluation and Research, 10903 New Hampshire Ave., Bldg. 31, Rm. 2426, Silver Spring, MD 20993–0002; 301–796–2721, email: Lauren.Tesh@fda.hhs.gov. Donna Mendrick, National Center for Toxicological Research, Bldg. 32, Rm. 2208, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–8892, FAX: 301–847–8600, email: Donna.Mendrick@fda.hhs.gov. Sujata Vijh, Center for Biologics Evaluation and Research, Division of Scientific Advisors and Consultants, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002; 240–402–7107, FAX: 301–595–1307, email: Sujata.Vijh@fda.hhs.gov. FDA is requesting nominations for voting and/ SUPPLEMENTARY INFORMATION: Allergenic Products Advisory Committee. Arthritis Advisory Committee. Circulatory System Devices Panel, Molecular and Clinical Genetics Panel. Dermatologic and Ophthalmic Drugs Advisory Committee. General and Plastic Surgery Devices Panel. Hematology & Pathology Devices Panel, Orthopaedic and Rehabilitation Devices Panel, and National Mammography and Quality Assurance Advisory Committee. Obstetrics and Gynecology Devices Panel. Oncologic Drugs Advisory Committee. Science Advisory Board to National Center for Toxicological Research (NCTR). Vaccines and Related Biological Products Advisory Committee. or nonvoting consumer representatives for the vacancies listed in Table 2: TABLE 2—COMMITTEE DESCRIPTIONS, TYPE OF CONSUMER VACANCY, AND APPROXIMATE DATE NEEDED asabaliauskas on DSK5VPTVN1PROD with NOTICES Committee/Panel/Areas of expertise needed Current and upcoming vacancies Allergenic Products Advisory Committee: Knowledgeable in the fields of allergy, immunology, pediatrics, internal medicine, biochemistry, and related specialties. Arthritis Drugs Advisory Committee: Knowledgeable in the fields of arthritis, rheumatology, orthopedics, epidemiology or statistics, analgesics, and related specialties. Circulatory System Devices Panel of the Medical Devices Advisory Committee: Knowledgeable in the safety and effectiveness of marked and investigational devices for use in the circulatory and vascular systems. Dermatologic & Ophthalmic Drugs Advisory Committee: Knowledgeable in the fields of dermatology, ophthalmology, internal medicine, pathology, immunology, epidemiology or statistics, and other related professions. General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee: Knowledgeable in the fields of general, plastic, reconstructive, pediatric, thoracic, abdominal, pelvic and endoscopic surgery; biomaterials, lasers, wound healing, and quality of life issues. One Voting .............. June 30, 2015. One Voting .............. September 30, 2015. One Non-Voting ....... Immediately. One Voting .............. August 31, 2015. One Non-Voting ....... Immediately. VerDate Sep<11>2014 17:49 Apr 02, 2015 Jkt 235001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 E:\FR\FM\03APN1.SGM 03APN1 Approximate date needed 18237 Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Notices TABLE 2—COMMITTEE DESCRIPTIONS, TYPE OF CONSUMER VACANCY, AND APPROXIMATE DATE NEEDED—Continued Current and upcoming vacancies Hematology and Pathology Devices Panel of the Medical Devices Advisory Committee: Knowledgeable in the fields of hematology, hematopathology, coagulation and homeostasis, hematological oncology, gynecological oncology. Molecular & Clinical Genetics Panel of the Medical Devices Advisory Committee: Experts in human genetics and in the clinical management of patients with genetic disorders, e.g., pediatricians, obstetricians, neonatologists. The Agency is also interested in considering candidates with training in inborn errors of metabolism, biochemical and/or molecular genetics, population genetics, epidemiology and related statistical training. Additionally, individuals with experience in genetic counseling, medical ethics as well as ancillary fields of study will be considered. Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee: Knowledgeable in the fields of perinatology, embryology, reproductive endocrinology, pediatric gynecology, gynecological oncology, operative hysteroscopy, pelviscopy, electrosurgery, laser surgery, assisted reproductive technologies, contraception, postoperative adhesions, and cervical cancer and colposcopy; obstetrics/gynecology devices; gynecology in the older patient; midwifery; labor and delivery nursing. Oncologic Drugs Advisory Committee: Knowledgeable in the fields of general oncology, pediatric oncology, hematologic oncology, immunologic oncology, biostatistics, and other related professions. National Mammography Quality Assurance Advisory Committee: Knowledgeable in clinical practice, research specialization, or professional work that has a significant focus on mammography. Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee: Knowledgeable in data concerning the safety and effectiveness of marketed and investigational orthopaedic and rehabilitation devices. Science Advisory Board to the NCTR: Knowledgeable in the fields related to toxicological research. Vaccines and Related Biological Products Advisory Committee Knowledgeable in the fields of immunology, molecular biology, rDNA, virology, bacteriology, epidemiology or biostatistics, allergy, preventive medicine, infectious diseases, pediatrics, microbiology, and biochemistry. asabaliauskas on DSK5VPTVN1PROD with NOTICES Committee/Panel/Areas of expertise needed One Non-Voting ....... Immediately. One Non-Voting ....... May 31, 2015. One Non-Voting ....... Immediately. One Voting .............. Immediately. Two Voting .............. Immediately. Two Non-Voting ....... Immediately. One Voting .............. June 30, 2015. One Voting .............. Immediately. I. Functions A. Allergenic Products Advisory 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 as well as the affirmation or revocation of biological product licenses, on the safety, effectiveness, and labeling of the products, on clinical and laboratory studies of such products, on amendments or revisions to regulations governing the manufacture, testing and licensing of allergenic biological products, and on the quality and relevance of FDA’s research programs. B. Arthritis Drugs Advisory Committee: Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of arthritis, rheumatism, and related diseases. C. 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. The panels engage in a number of activities to fulfill the VerDate Sep<11>2014 17:49 Apr 02, 2015 Jkt 235001 functions the Federal Food, Drug, and Cosmetic Act (the FD&C Act) envisions for device advisory panels. With the exception of the Medical Devices Dispute Resolution Panel, each panel, according to its specialty area, advises the Commissioner of Food and Drugs (the Commissioner) regarding recommended 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 FD&C 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 on issues relating to the design of clinical studies regarding the safety and effectiveness of marketed and investigational devices. D. Dermatologic and Ophthalmic Drugs Advisory Committee: Reviews and evaluates available data concerning PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 Approximate date needed the safety and effectiveness of marketed and investigational human drug products for use in the treatment of dermatologic and ophthalmic disorders. E. 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 which should be considered in the oversight of mammography facilities; (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. F. Oncologic Drugs Advisory Committee: Reviews and evaluates data concerning the safety and effectiveness E:\FR\FM\03APN1.SGM 03APN1 18238 Federal Register / Vol. 80, No. 64 / Friday, April 3, 2015 / Notices of marketed and investigational human drug products for use in the treatment of cancer. G. Science Advisory Board to the National Center for Toxicological Research: Reviews and advises the Agency on the establishment, implementation and evaluation of the research programs and regulatory responsibilities as it relates to NCTR. The Board will also provide an extraAgency review in ensuring that the research programs at NCTR are scientifically sound and pertinent. H. Vaccines and Related Biological Products Advisory Committee: Reviews and evaluates data concerning the safety, effectiveness, and appropriate use of vaccines and related biological products which are intended for use in the prevention, treatment, or diagnosis of human diseases, as well as considers the quality and relevance of FDA’s research program which provides scientific support for the regulation of these products. II. Criteria for Members Persons nominated for membership as consumer representatives on 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. asabaliauskas on DSK5VPTVN1PROD with NOTICES 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. VerDate Sep<11>2014 17:49 Apr 02, 2015 Jkt 235001 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 at least two 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. Nominations should include a cover letter and a current curriculum vitae or resume for each nominee, including a current business and/or home address, telephone number, and email address if available, and a list of consumer or community-based organizations for which the candidate can demonstrate active participation. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and therefore, encourages nominations of appropriately qualified candidates from these groups. Nominations should also 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, unless selfnominated. FDA will ask potential candidates 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. Members will be invited to serve for terms up to 4 years. FDA will review all nominations received within the specified timeframes and prepare a ballot containing the names of 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 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 voting or nonvoting consumer representatives will not participate in the selection process. Dated: March 30, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–07605 Filed 4–2–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day–15–0929] Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies. Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses; and (e) Assess information collection costs. To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639–7570 or send an email to omb@cdc.gov. Written comments and/or suggestions regarding the items contained in this notice should be directed to the Attention: CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 395–5806. Written E:\FR\FM\03APN1.SGM 03APN1

Agencies

[Federal Register Volume 80, Number 64 (Friday, April 3, 2015)]
[Notices]
[Pages 18235-18238]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-07605]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0001]

Request for Nominations for Individuals and Consumer
Organizations for Advisory Committees

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 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 September 30, 2015.

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 the FDA (see ADDRESSES) by May
4, 2015, for vacancies listed in this notice. Concurrently, nomination
materials for prospective candidates should be sent to FDA (see
ADDRESSES) by May 4, 2015.

ADDRESSES: All statements of interest from consumer organizations
interested in participating in the selection process and consumer
representative nominations should submit your information
electronically to

[[Page 18236]]

kimberly.hamilton@fda.hhs.gov or by mail to Advisory Committee
Oversight and Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm.
5103, Silver Spring, MD 20993-0002, or FAX: 301-847-8640.
Consumer Representative nominations should be submitted
electronically by logging into the FDA advisory Committee Membership
Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm or by mail to Advisory Committee Oversight and
Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver
Spring, MD 20993-0002, or FAX: 301-847-8640. Additional information
about becoming a member on an FDA advisory committee can also be
obtained by visiting FDA's Web site at https://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT: Kimberly Hamilton, Advisory Committee
Oversight and Management Staff, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 5117, Silver Spring, MD 20993-0002;. 301-
796-8224, email: kimberly.hamilton@fda.hhs.gov.
For questions relating to specific advisory committees or panels,
contact the following persons listed in table 1 of this document:

Table 1--Advisory Committee Contacts
------------------------------------------------------------------------
Contact person Committee/Panel
------------------------------------------------------------------------
Janie Kim, Center for Biologics Evaluation Allergenic Products
and Research, Food and Drug Administration, Advisory Committee.
10903 New Hampshire Ave., Bldg. 71, Rm.
6129, Silver Spring, MD 20993; 301-796-9016,
email: Janie.Kim@fda.hhs.gov.
Stephanie Begansky, Center for Drug Arthritis Advisory
Evaluation and Research, Division of Committee.
Advisory Committee and Consultant
Management, Office of Executive Programs,
10903 New Hampshire Ave., Bldg. 31, Rm.
2426, Silver Spring, MD 20993-0002; 301-796-
3693, FAX: 301-847-8533, email:
Stephanie.Begansky@fda.hhs.gov.
Jamie Waterhouse, Center for Devices and Circulatory System
Radiological Health, Office of Device Devices Panel, Molecular
Evaluation, 10903 New Hampshire Ave., Bldg. and Clinical Genetics
66, Rm. 1544, Silver Spring, MD 20993-0002; Panel.
301-796-3063, FAX: 301-847-8122, email:
Jamie.Waterhouse@fda.hhs.gov.
Yvette Waples, Center for Drug Evaluation & Dermatologic and
Research, Division of Advisory Committee and Ophthalmic Drugs
Consultant Management, Office of Executive Advisory Committee.
Programs, 10993 New Hampshire Ave., Bldg.
31, Rm. 2510, Silver Spring, MD 20993-0002;
301-796-9034 FAX: 301-847-8533 email:
Yvette.Waples@fda.hhs.gov.
Patricio Garcia, Center for Devices and General and Plastic
Radiological Health, Office of Device Surgery Devices Panel.
Evaluation, 10903 New Hampshire Ave., Bldg.
66, Rm. RMG 465 HFZ-410, Silver Spring, MD
20903-0002, 301-796-6875, FAX: 301-847-8120,
email: Patricio.Garcia@fda.hhs.gov.
Sara J. Anderson, Center for Devices and Hematology & Pathology
Radiological Health, Office of Device Devices Panel,
Evaluation, 10903 New Hampshire Ave., Bldg. Orthopaedic and
66, Rm. 1544, Silver Spring, MD 20903-0002; Rehabilitation Devices
301-796-7047, FAX: 301-847-8122, email: Panel, and National
Sara.Anderson@fda.hhs.gov. Mammography and Quality
Assurance Advisory
Committee.
Shanika Craig, Food and Drug Administration, Obstetrics and Gynecology
10903 New Hampshire Ave., Bldg. 66 Rm. 1613, Devices Panel.
Silver Spring, MD 20993-0002; 301-796-6639,
FAX: 301-847-8120, email:
Shanika.Craig@fda.hhs.gov.
Lauren Tesh, Center for Drug Evaluation and Oncologic Drugs Advisory
Research, 10903 New Hampshire Ave., Bldg. Committee.
31, Rm. 2426, Silver Spring, MD 20993-0002;
301-796-2721, email: Lauren.Tesh@fda.hhs.gov.
Donna Mendrick, National Center for Science Advisory Board to
Toxicological Research, Bldg. 32, Rm. 2208, National Center for
10903 New Hampshire Ave., Silver Spring, MD Toxicological Research
20993-0002, 301-796-8892, FAX: 301-847-8600, (NCTR).
email: Donna.Mendrick@fda.hhs.gov.
Sujata Vijh, Center for Biologics Evaluation Vaccines and Related
and Research, Division of Scientific Biological Products
Advisors and Consultants, 10903 New Advisory Committee.
Hampshire Ave., Silver Spring, MD 20993-
0002; 240-402-7107, FAX: 301-595-1307,
email: Sujata.Vijh@fda.hhs.gov.
------------------------------------------------------------------------

SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting
and/or nonvoting consumer representatives for the vacancies listed in
Table 2:

Table 2--Committee Descriptions, Type of Consumer Vacancy, and Approximate Date Needed
----------------------------------------------------------------------------------------------------------------
Committee/Panel/Areas of expertise
needed Current and upcoming vacancies Approximate date needed
----------------------------------------------------------------------------------------------------------------
Allergenic Products Advisory One Voting......................... June 30, 2015.
Committee: Knowledgeable in the
fields of allergy, immunology,
pediatrics, internal medicine,
biochemistry, and related specialties.
Arthritis Drugs Advisory Committee: One Voting......................... September 30, 2015.
Knowledgeable in the fields of
arthritis, rheumatology, orthopedics,
epidemiology or statistics,
analgesics, and related specialties.
Circulatory System Devices Panel of One Non-Voting..................... Immediately.
the Medical Devices Advisory
Committee: Knowledgeable in the
safety and effectiveness of marked
and investigational devices for use
in the circulatory and vascular
systems.
Dermatologic & Ophthalmic Drugs One Voting......................... August 31, 2015.
Advisory Committee: Knowledgeable in
the fields of dermatology,
ophthalmology, internal medicine,
pathology, immunology, epidemiology
or statistics, and other related
professions.
General and Plastic Surgery Devices One Non-Voting..................... Immediately.
Panel of the Medical Devices Advisory
Committee: Knowledgeable in the
fields of general, plastic,
reconstructive, pediatric, thoracic,
abdominal, pelvic and endoscopic
surgery; biomaterials, lasers, wound
healing, and quality of life issues.

[[Page 18237]]

Hematology and Pathology Devices Panel One Non-Voting..................... Immediately.
of the Medical Devices Advisory
Committee: Knowledgeable in the
fields of hematology,
hematopathology, coagulation and
homeostasis, hematological oncology,
gynecological oncology.
Molecular & Clinical Genetics Panel of One Non-Voting..................... May 31, 2015.
the Medical Devices Advisory
Committee: Experts in human genetics
and in the clinical management of
patients with genetic disorders,
e.g., pediatricians, obstetricians,
neonatologists. The Agency is also
interested in considering candidates
with training in inborn errors of
metabolism, biochemical and/or
molecular genetics, population
genetics, epidemiology and related
statistical training. Additionally,
individuals with experience in
genetic counseling, medical ethics as
well as ancillary fields of study
will be considered.
Obstetrics and Gynecology Devices One Non-Voting..................... Immediately.
Panel of the Medical Devices Advisory
Committee: Knowledgeable in the
fields of perinatology, embryology,
reproductive endocrinology, pediatric
gynecology, gynecological oncology,
operative hysteroscopy, pelviscopy,
electrosurgery, laser surgery,
assisted reproductive technologies,
contraception, postoperative
adhesions, and cervical cancer and
colposcopy; obstetrics/gynecology
devices; gynecology in the older
patient; midwifery; labor and
delivery nursing.
Oncologic Drugs Advisory Committee: One Voting......................... Immediately.
Knowledgeable in the fields of
general oncology, pediatric oncology,
hematologic oncology, immunologic
oncology, biostatistics, and other
related professions.
National Mammography Quality Assurance Two Voting......................... Immediately.
Advisory Committee: Knowledgeable in
clinical practice, research
specialization, or professional work
that has a significant focus on
mammography.
Orthopaedic and Rehabilitation Devices Two Non-Voting..................... Immediately.
Panel of the Medical Devices Advisory
Committee: Knowledgeable in data
concerning the safety and
effectiveness of marketed and
investigational orthopaedic and
rehabilitation devices.
Science Advisory Board to the NCTR: One Voting......................... June 30, 2015.
Knowledgeable in the fields related
to toxicological research.
Vaccines and Related Biological One Voting......................... Immediately.
Products Advisory Committee
Knowledgeable in the fields of
immunology, molecular biology, rDNA,
virology, bacteriology, epidemiology
or biostatistics, allergy, preventive
medicine, infectious diseases,
pediatrics, microbiology, and
biochemistry.
----------------------------------------------------------------------------------------------------------------

I. Functions

A. Allergenic Products Advisory 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 as well as
the affirmation or revocation of biological product licenses, on the
safety, effectiveness, and labeling of the products, on clinical and
laboratory studies of such products, on amendments or revisions to
regulations governing the manufacture, testing and licensing of
allergenic biological products, and on the quality and relevance of
FDA's research programs.
B. Arthritis Drugs Advisory Committee: Reviews and evaluates data
concerning the safety and effectiveness of marketed and investigational
human drug products for use in the treatment of arthritis, rheumatism,
and related diseases.
C. 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. The panels engage in a number of activities to
fulfill the functions the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) envisions for device advisory panels. With the exception of
the Medical Devices Dispute Resolution Panel, each panel, according to
its specialty area, advises the Commissioner of Food and Drugs (the
Commissioner) regarding recommended 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 FD&C 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 on issues relating to the design of clinical studies
regarding the safety and effectiveness of marketed and investigational
devices.
D. Dermatologic and Ophthalmic Drugs Advisory Committee: Reviews
and evaluates available data concerning the safety and effectiveness of
marketed and investigational human drug products for use in the
treatment of dermatologic and ophthalmic disorders.
E. 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 which should be considered in the oversight of mammography
facilities; (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.
F. Oncologic Drugs Advisory Committee: Reviews and evaluates data
concerning the safety and effectiveness

[[Page 18238]]

of marketed and investigational human drug products for use in the
treatment of cancer.
G. Science Advisory Board to the National Center for Toxicological
Research: Reviews and advises the Agency on the establishment,
implementation and evaluation of the research programs and regulatory
responsibilities as it relates to NCTR. The Board will also provide an
extra-Agency review in ensuring that the research programs at NCTR are
scientifically sound and pertinent.
H. Vaccines and Related Biological Products Advisory Committee:
Reviews and evaluates data concerning the safety, effectiveness, and
appropriate use of vaccines and related biological products which are
intended for use in the prevention, treatment, or diagnosis of human
diseases, as well as considers the quality and relevance of FDA's
research program which provides scientific support for the regulation
of these products.

II. Criteria for Members

Persons nominated for membership as consumer representatives on
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 at least two
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.
Nominations should include a cover letter and a current curriculum
vitae or resume for each nominee, including a current business and/or
home address, telephone number, and email address if available, and a
list of consumer or community-based organizations for which the
candidate can demonstrate active participation. FDA seeks to include
the views of women and men, members of all racial and ethnic groups,
and individuals with and without disabilities on its advisory
committees and therefore, encourages nominations of appropriately
qualified candidates from these groups.
Nominations should also 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, unless self-nominated. FDA will ask potential candidates 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. Members will
be invited to serve for terms up to 4 years.
FDA will review all nominations received within the specified
timeframes and prepare a ballot containing the names of 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.

Dated: March 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07605 Filed 4-2-15; 8:45 am]
BILLING CODE 4164-01-P

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