Request for Nominations for Voting and/or Nonvoting Consumer Representatives on Public Advisory Committees or Panels and Request for Notification From Consumer Organizations Interested in Participating in the Selection Process for Nominations for Voting and/or Nonvoting Consumer Representatives on Public Advisory Committees or Panels, 16010-16013 [2014-06326]

Download as PDF 16010 Federal Register / Vol. 79, No. 56 / Monday, March 24, 2014 / Notices will be posted to the docket at https:// www.regulations.gov. Dated: March 18, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–06371 Filed 3–21–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0001] Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. WREIER-AVILES on DSK5TPTVN1PROD with NOTICES ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Anesthetic and Analgesic Drug Products Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency on FDA’s regulatory issues. Date and Time: The meeting will be held on April 22, 2014, from 8 a.m. to 5 p.m. Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993–0002. Information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/ AdvisoryCommittees/default.htm; under the heading ‘‘Resources for You,’’ click on ‘‘Public Meetings at the FDA White Oak Campus.’’ Please note that visitors to the White Oak Campus must enter through Building 1. Contact Person: Caleb Briggs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2428, Silver Spring, MD 20993–0002, 301– 796–9001, FAX: 301–847–8533, email: AADPAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the VerDate Mar<15>2010 14:29 Mar 21, 2014 Jkt 232001 Agency’s Web site at https:// www.fda.gov/AdvisoryCommittees/ default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. Agenda: The committee will discuss the safety and efficacy for new drug application 203077, MOXDUO (morphine sulfate and oxycodone hydrochloride) capsules, QRxPharma Inc., for the proposed indication of management of moderate to severe acute pain where the use of an opioid analgesic is appropriate. This product represents the first drug combination consisting of two immediate-release opioids. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before April 8, 2014. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before March 31, 2014. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by April 1, 2014. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Caleb Briggs at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at https://www.fda.gov/ AdvisoryCommittees/ AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: March 19, 2014. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2014–06325 Filed 3–21–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–0001] Request for Nominations for Voting and/or Nonvoting Consumer Representatives on Public Advisory Committees or Panels and Request for Notification From Consumer Organizations Interested in Participating in the Selection Process for Nominations for Voting and/or Nonvoting 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 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 SUMMARY: E:\FR\FM\24MRN1.SGM 24MRN1 16011 Federal Register / Vol. 79, No. 56 / Monday, March 24, 2014 / Notices accepted for current vacancies and for those that will or may occur through December 2014. 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. 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 April 23, 2014, for vacancies listed in this notice. Concurrently, nomination materials for DATES: prospective candidates should be sent to FDA (see ADDRESSES) by April 23, 2014. ADDRESSES: All statements of interest from consumer organizations interested in participating in the selection process should be submitted electronically to dornette.spelllesane@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 by FAX to 301–847–8640. Consumer Representative nominations should be submitted electronically by logging accessing the FDA Advisory Committee Membership Nomination Portal at 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 by FAX to 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 GENERAL INFORMATION CONTACT: Dornette Spell-LeSane, Advisory Committee Oversight and Management Staff (ACOMS), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993–0002, 301 796–8224, dornette.spelllesane@ 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 Karen Strambler, Center for Food Safety and Applied Nutrition, FDA College Park, CPK1, Rm. 1C016, College Park, MD 20740, 240– 402–2589, FAX: 301–436–2637, Karen.Strambler@fda.hhs.gov. Avena Russell, ABD, Center for Devices and Radiological Health, Office of Device Evaluation, 10903 New Hampshire Ave., Bldg. 66, Rm. 1535, Silver Spring, MD 20993, 301–796–3805, FAX: 301–847– 8122, Avena.Russell@fda.hhs.gov. Sara J. Anderson, LCDR, U.S. Public Health Service, Center for Devices and Radiological Health, Office of Device Evaluation, 10903 New Hampshire Ave., Bldg. 66, Rm.1544, Silver Spring, MD 20903, 301–796–7047, FAX: 301–847–8122, Sara.Anderson@fda.hhs.gov. Pamela Scott, Center for Devices and Radiological Health. Office of the Center Director, 10903 New Hampshire Ave., Bldg. 66, Rm. 5406, Silver Spring, MD 20993, 301–796–5433, FAX: 301–847–8510, Pamela.Scott@fda.hhs.gov. Shanika Craig, Food and Drug Administration, Bldg. 66, Rm. 1613, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301– 796–6639, FAX: 301–847–812, Shanika.Craig@fda.hhs.gov. Walter Ellenberg, Office of the Commissioner, Office of Pediatric Therapeutics, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–0885, FAX: 301– 847–8640, Walter.Ellenberg@fda.hhs.gov. Kalyani Bhatt, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Silver Spring, MD 20993–0002, 301–796–0063, FAX: 301–847–8533, Kalyani.Bhatt@fda.hhs.gov. FDA is requesting nominations for voting and/ or nonvoting consumer representatives SUPPLEMENTARY INFORMATION: Food Advisory Committee. General and Plastic Surgery Devices Panel. Hematology and Pathology Devices Panel, Orthopaedic and Rehabilitation Devices Panel and National Mammography and Quality Assurance. Medical Devices Dispute Resolution Panel. Obstetrics and Gynecology Devices Panel. Pediatrics Advisory Committee. Psychopharmacologic Drugs Advisory Committee and Reproductive Health Drugs Advisory Committee. for the vacancies listed in Table 2 of this document: TABLE 2—COMMITTEE DESCRIPTIONS, TYPE OF CONSUMER REPRESENTATIVE VACANCY AND APPROXIMATE DATE NEEDED WREIER-AVILES on DSK5TPTVN1PROD with NOTICES Committee/Panel/Areas of expertise needed Current & upcoming vacancies Food Advisory Committee—Knowledgeable in the fields of physical sciences, biological and life sciences, food science, risk assessment, nutrition, food technology, molecular biology, and other relevant scientific and technical disciplines. Medical Devices Advisory Committee, General and Plastic Surgery Devices Panel—Knowledgeable in the fields of general, plastic, reconstructive, pediatric, thoracic, abdominal, pelvic and endoscopic surgery; biomaterials, lasers, wound healing, and quality of life issues. Medical Devices Advisory Committee, Hematology and Pathology Devices Panel—Knowledgeable in the fields of hematology, hematopathology, coagulation and homeostasis, hematological oncology, gynecological oncology. 1-voting .................. Immediately. 1-nonvoting ............ 9/1/2014. 1-nonvoting ............ 3/1/2014. VerDate Mar<15>2010 14:29 Mar 21, 2014 Jkt 232001 PO 00000 Frm 00079 Fmt 4703 Sfmt 4703 E:\FR\FM\24MRN1.SGM 24MRN1 Approximate date needed 16012 Federal Register / Vol. 79, No. 56 / Monday, March 24, 2014 / Notices TABLE 2—COMMITTEE DESCRIPTIONS, TYPE OF CONSUMER REPRESENTATIVE VACANCY AND APPROXIMATE DATE NEEDED—Continued Committee/Panel/Areas of expertise needed Current & upcoming vacancies Medical Devices Advisory Committee, Medical Devices Dispute Resolution Panel—Experts with broad, cross-cutting scientific, clinical, analytical or mediation skills. National Mammography Quality Assurance—Knowledgeable in clinical practice, research specialization, or professional work that has a significant focus on mammography. Medical Devices Advisory Committee, Obstetrics and Gynecology Devices Panel—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. Orthopaedic and Rehabilitation Devices Panel—Knowledgeable in data concerning the safety and effectiveness of marketed and investigational orthopaedic and rehabilitation devices. Pediatrics Advisory Committee—Knowledgeable in pediatric research, pediatric subspecialties, statistics, and/or biomedical ethics. Psychopharmacologic Drugs Advisory Committee—Knowledgeable in the fields of psychopharmacology, psychiatry, epidemiology or statistics, and related specialties. Reproductive Health Drugs Advisory Committee—Knowledgeable in the fields of obstetrics, gynecology, endocrinology, pediatrics, epidemiology or statistics and related specialties. 1-nonvoting ............ 10/1/2014. 1–nonvoting ........... Immediately. 1-nonvoting ............ Immediately. 1-nonvoting ............ Immediately. 1-voting .................. 7/1/2014. 1-voting .................. 7/1/2014. 1-voting .................. 7/1/2014. I. Functions WREIER-AVILES on DSK5TPTVN1PROD with NOTICES A. 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 (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. VerDate Mar<15>2010 14:29 Mar 21, 2014 Jkt 232001 B. The Medical Devices Dispute Resolution Panel The Panel provides advice to the Commissioner on complex or contested scientific issues between the FDA and medical device sponsors, applicants, or manufacturers relating to specific products, marketing applications, regulatory decisions and actions by FDA, and Agency guidance and policies. The Panel makes recommendations on issues that are lacking resolution, are highly complex in nature, or result from challenges to regular advisory panel proceedings or Agency decisions or actions. C. Food Advisory Committee The Committee provides advice to the Commissioner of Food and Drugs and other appropriate officials, on emerging food safety, food science, nutrition, and other food-related health issues that the FDA considers of primary importance for its food and cosmetics programs. The Committee may be charged with reviewing and evaluating available data and making recommendations on matters such as those relating to: (1) Broad scientific and technical food or cosmetic related issues; (2) the safety of new foods and food ingredients; (3) labeling of foods and cosmetics; (4) nutrient needs and nutritional adequacy; and (5) safe exposure limits for food contaminants. The Committee may also be asked to provide advice and make recommendations on ways of communicating to the public the potential risks associated with these issues and on approaches that might be considered for addressing the issues. PO 00000 Frm 00080 Fmt 4703 Sfmt 4703 Approximate date needed 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 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. E. Pediatric Advisory Committee The Committee advises and makes recommendations to the Commissioner of Food and Drugs regarding (1) pediatric research; (2) identification of research priorities related to pediatric therapeutics and the need for additional treatments of specific pediatric diseases or conditions; (3) the ethics, design, and analysis of clinical trials related to pediatric therapeutics; (4) pediatric labeling disputes; (5) pediatric labeling changes; (6) adverse event reports for drugs granted pediatric exclusivity and E:\FR\FM\24MRN1.SGM 24MRN1 Federal Register / Vol. 79, No. 56 / Monday, March 24, 2014 / Notices any safety issues that may occur; (7) any other pediatric issue or pediatric labeling dispute involving FDA regulated products; (8) research involving children as subjects; and (9) any other matter involving pediatrics for which FDA has regulatory responsibility. The Committee also advises and makes recommendations to the Secretary directly or to the Secretary through the Commissioner on research involving children as subjects that is conducted or supported by the Department of Health and Human Services. F. Psychopharmacologic Drugs Advisory Committee Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the practice of psychiatry and related fields. G. Reproductive Health Drugs Advisory Committee Reviews and evaluates data on the safety and effectiveness of marketed and investigational human drugs for use in the practice of obstetrics, gynecology, and related specialties. WREIER-AVILES on DSK5TPTVN1PROD with NOTICES 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 VerDate Mar<15>2010 14:29 Mar 21, 2014 Jkt 232001 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. 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 and is willing to serve as a member of the advisory committee or panel if selected, and appears to have no conflicts of interest. 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 PO 00000 Frm 00081 Fmt 4703 Sfmt 4703 16013 representatives will not participate in the selection process. Dated: March 18, 2014. Jill Hartzler Warner, Acting Associate Commissioner for Special Medical Programs. [FR Doc. 2014–06326 Filed 3–21–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request Health Resources and Services Administration, HHS. ACTION: Notice. AGENCY: In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. DATES: Comments on this ICR should be received within 30 days of this notice. ADDRESSES: Submit your comments, including the Information Collection Request Title, to the desk officer for HRSA, either by email to OIRA_ submission@omb.eop.gov or by fax to 202–395–5806. FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance requests submitted to OMB for review, email the HRSA Information Collection Clearance Officer at paperwork@hrsa.gov or call (301) 443–1984. SUPPLEMENTARY INFORMATION: Information Collection Request Title: Application and Other Forms utilized by the National Health Service Corps Scholarship Program, the NHSC Students to Service Loan Repayment Program, and the Native Hawaiian Health Scholarship Program. SUMMARY: OMB No. 0915–0146—Revision Abstract: Administered by HRSA’s Bureau of Clinician Recruitment and Service (BCRS), the National Health Service Corps (NHSC) Scholarship Program (SP), NHSC Students to Service Loan Repayment Program (S2S LRP), E:\FR\FM\24MRN1.SGM 24MRN1

Agencies

[Federal Register Volume 79, Number 56 (Monday, March 24, 2014)]
[Notices]
[Pages 16010-16013]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-06326]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0001]


Request for Nominations for Voting and/or Nonvoting Consumer 
Representatives on Public Advisory Committees or Panels and Request for 
Notification From Consumer Organizations Interested in Participating in 
the Selection Process for Nominations for Voting and/or Nonvoting 
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 be self-nominated or may be nominated by a consumer 
organization. Nominations will be

[[Page 16011]]

accepted for current vacancies and for those that will or may occur 
through December 2014.
    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.

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 
April 23, 2014, for vacancies listed in this notice. Concurrently, 
nomination materials for prospective candidates should be sent to FDA 
(see ADDRESSES) by April 23, 2014.

ADDRESSES: All statements of interest from consumer organizations 
interested in participating in the selection process should be 
submitted electronically to dornette.spelllesane@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 by 
FAX to 301-847-8640.
    Consumer Representative nominations should be submitted 
electronically by logging accessing the FDA Advisory Committee 
Membership Nomination Portal at 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 by FAX to 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 GENERAL INFORMATION CONTACT: Dornette Spell-LeSane, 
Advisory Committee Oversight and Management Staff (ACOMS), Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, 
Silver Spring, MD 20993-0002, 301 796-8224, 
dornette.spelllesane@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
------------------------------------------------------------------------
Karen Strambler, Center for Food Safety  Food Advisory Committee.
 and Applied Nutrition, FDA College
 Park, CPK1, Rm. 1C016, College Park,
 MD 20740, 240-402-2589, FAX: 301-436-
 2637, Karen.Strambler@fda.hhs.gov.
Avena Russell, ABD, Center for Devices   General and Plastic Surgery
 and Radiological Health, Office of       Devices Panel.
 Device Evaluation, 10903 New Hampshire
 Ave., Bldg. 66, Rm. 1535, Silver
 Spring, MD 20993, 301-796-3805, FAX:
 301-847-8122,
 Avena.Russell@fda.hhs.gov.
Sara J. Anderson, LCDR, U.S. Public      Hematology and Pathology
 Health Service, Center for Devices and   Devices Panel, Orthopaedic and
 Radiological Health, Office of Device    Rehabilitation Devices Panel
 Evaluation, 10903 New Hampshire Ave.,    and National Mammography and
 Bldg. 66, Rm.1544, Silver Spring, MD     Quality Assurance.
 20903, 301-796-7047, FAX: 301-847-
 8122, Sara.Anderson@fda.hhs.gov.
Pamela Scott, Center for Devices and     Medical Devices Dispute
 Radiological Health. Office of the       Resolution Panel.
 Center Director, 10903 New Hampshire
 Ave., Bldg. 66, Rm. 5406, Silver
 Spring, MD 20993, 301-796-5433, FAX:
 301-847-8510, Pamela.Scott@fda.hhs.gov.
Shanika Craig, Food and Drug             Obstetrics and Gynecology
 Administration, Bldg. 66, Rm. 1613,      Devices Panel.
 10903 New Hampshire Ave., Silver
 Spring, MD 20993-0002, 301-796-6639,
 FAX: 301-847-812,
 Shanika.Craig@fda.hhs.gov.
Walter Ellenberg, Office of the          Pediatrics Advisory Committee.
 Commissioner, Office of Pediatric
 Therapeutics, Food and Drug
 Administration, 10903 New Hampshire
 Ave., Silver Spring, MD 20993-0002,
 301-796-0885, FAX: 301-847-8640,
 Walter.Ellenberg@fda.hhs.gov.
Kalyani Bhatt, Center for Drug           Psychopharmacologic Drugs
 Evaluation and Research, Food and Drug   Advisory Committee and
 Administration, 10903 New Hampshire      Reproductive Health Drugs
 Ave., Bldg. 31, Silver Spring, MD        Advisory Committee.
 20993-0002, 301-796-0063, FAX: 301-847-
 8533, Kalyani.Bhatt@fda.hhs.gov.
------------------------------------------------------------------------


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

      Table 2--Committee Descriptions, Type of Consumer Representative Vacancy and Approximate Date Needed
----------------------------------------------------------------------------------------------------------------
   Committee/Panel/Areas of expertise
                 needed                      Current & upcoming vacancies           Approximate date needed
----------------------------------------------------------------------------------------------------------------
Food Advisory Committee--Knowledgeable   1-voting...........................  Immediately.
 in the fields of physical sciences,
 biological and life sciences, food
 science, risk assessment, nutrition,
 food technology, molecular biology,
 and other relevant scientific and
 technical disciplines.
Medical Devices Advisory Committee,      1-nonvoting........................  9/1/2014.
 General and Plastic Surgery Devices
 Panel--Knowledgeable in the fields of
 general, plastic, reconstructive,
 pediatric, thoracic, abdominal, pelvic
 and endoscopic surgery; biomaterials,
 lasers, wound healing, and quality of
 life issues.
Medical Devices Advisory Committee,      1-nonvoting........................  3/1/2014.
 Hematology and Pathology Devices
 Panel--Knowledgeable in the fields of
 hematology, hematopathology,
 coagulation and homeostasis,
 hematological oncology, gynecological
 oncology.

[[Page 16012]]

 
Medical Devices Advisory Committee,      1-nonvoting........................  10/1/2014.
 Medical Devices Dispute Resolution
 Panel--Experts with broad, cross-
 cutting scientific, clinical,
 analytical or mediation skills.
National Mammography Quality Assurance-- 1-nonvoting........................  Immediately.
 Knowledgeable in clinical practice,
 research specialization, or
 professional work that has a
 significant focus on mammography.
Medical Devices Advisory Committee,      1-nonvoting........................  Immediately.
 Obstetrics and Gynecology Devices
 Panel--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.
Orthopaedic and Rehabilitation Devices   1-nonvoting........................  Immediately.
 Panel--Knowledgeable in data
 concerning the safety and
 effectiveness of marketed and
 investigational orthopaedic and
 rehabilitation devices.
Pediatrics Advisory Committee--          1-voting...........................  7/1/2014.
 Knowledgeable in pediatric research,
 pediatric subspecialties, statistics,
 and/or biomedical ethics.
Psychopharmacologic Drugs Advisory       1-voting...........................  7/1/2014.
 Committee--Knowledgeable in the fields
 of psychopharmacology, psychiatry,
 epidemiology or statistics, and
 related specialties.
Reproductive Health Drugs Advisory       1-voting...........................  7/1/2014.
 Committee--Knowledgeable in the fields
 of obstetrics, gynecology,
 endocrinology, pediatrics,
 epidemiology or statistics and related
 specialties.
----------------------------------------------------------------------------------------------------------------

I. Functions

A. 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 (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.

B. The Medical Devices Dispute Resolution Panel

    The Panel provides advice to the Commissioner on complex or 
contested scientific issues between the FDA and medical device 
sponsors, applicants, or manufacturers relating to specific products, 
marketing applications, regulatory decisions and actions by FDA, and 
Agency guidance and policies. The Panel makes recommendations on issues 
that are lacking resolution, are highly complex in nature, or result 
from challenges to regular advisory panel proceedings or Agency 
decisions or actions.

C. Food Advisory Committee

    The Committee provides advice to the Commissioner of Food and Drugs 
and other appropriate officials, on emerging food safety, food science, 
nutrition, and other food-related health issues that the FDA considers 
of primary importance for its food and cosmetics programs. The 
Committee may be charged with reviewing and evaluating available data 
and making recommendations on matters such as those relating to: (1) 
Broad scientific and technical food or cosmetic related issues; (2) the 
safety of new foods and food ingredients; (3) labeling of foods and 
cosmetics; (4) nutrient needs and nutritional adequacy; and (5) safe 
exposure limits for food contaminants. The Committee may also be asked 
to provide advice and make recommendations on ways of communicating to 
the public the potential risks associated with these issues and on 
approaches that might be considered for addressing the issues.

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 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.

E. Pediatric Advisory Committee

    The Committee advises and makes recommendations to the Commissioner 
of Food and Drugs regarding (1) pediatric research; (2) identification 
of research priorities related to pediatric therapeutics and the need 
for additional treatments of specific pediatric diseases or conditions; 
(3) the ethics, design, and analysis of clinical trials related to 
pediatric therapeutics; (4) pediatric labeling disputes; (5) pediatric 
labeling changes; (6) adverse event reports for drugs granted pediatric 
exclusivity and

[[Page 16013]]

any safety issues that may occur; (7) any other pediatric issue or 
pediatric labeling dispute involving FDA regulated products; (8) 
research involving children as subjects; and (9) any other matter 
involving pediatrics for which FDA has regulatory responsibility. The 
Committee also advises and makes recommendations to the Secretary 
directly or to the Secretary through the Commissioner on research 
involving children as subjects that is conducted or supported by the 
Department of Health and Human Services.

F. Psychopharmacologic Drugs Advisory Committee

    Reviews and evaluates data concerning the safety and effectiveness 
of marketed and investigational human drug products for use in the 
practice of psychiatry and related fields.

G. Reproductive Health Drugs Advisory Committee

    Reviews and evaluates data on the safety and effectiveness of 
marketed and investigational human drugs for use in the practice of 
obstetrics, gynecology, and related specialties.

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 r[eacute]sum[eacute] 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.
    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 
and is willing to serve as a member of the advisory committee or panel 
if selected, and appears to have no conflicts of interest. 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 18, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-06326 Filed 3-21-14; 8:45 am]
BILLING CODE 4160-01-P
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