Request for Nominations for Individuals and Consumer Organizations for Advisory Committees, 37608-37611 [2016-13733]

Download as PDF 37608 Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Notices asabaliauskas on DSK3SPTVN1PROD with NOTICES approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became effective: December 9, 2002. The applicant claims December 14, 2002, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was December 9, 2002, which was the first date after receipt of the IND that the investigational studies were allowed to proceed. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the FD&C Act: April 10, 2012. FDA has verified the applicant’s claim that the new drug application (NDA) for POMALYST (NDA 204026) was initially submitted on April 10, 2012. 3. The date the application was approved: February 8, 2013. FDA has verified the applicant’s claim that NDA 204026 was approved on February 8, 2013. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 5 years or 241 days of patent term extension. III. Petitions Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and ask for a redetermination (see DATES). Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must be timely (see DATES) and contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Submit petitions electronically to https://www.regulations.gov at Docket No. FDA–2013–S–0610. Submit written petitions (two copies are required) to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: June 3, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–13796 Filed 6–9–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–0001] Request for Nominations for Individuals and Consumer Organizations for Advisory Committees 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. 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 FDA (see ADDRESSES) by July 11, 2016, for vacancies listed in this notice. Concurrently, nomination materials for SUMMARY: prospective candidates should be sent to FDA (see ADDRESSES) by July 11, 2016. Nominations will be accepted for current vacancies and for those that will or may occur through August 31, 2016. ADDRESSES: All statements of interest from consumer organizations interested in participating in the selection process and consumer representative nominations should be submitted electronically to kimberly.hamilton@ fda.hhs.gov, 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: 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, 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: 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 questions relating to participation in the selection process: Kimberly Hamilton, Advisory Committee Oversight and Management Staff (ACOMS), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver Spring, MD 20993–0002, 301– 796–8220 email: kimberly.hamilton@ fda.hhs.gov. For questions relating to specific advisory committees or panels, contact the appropriate Contact Person listed in table 1 in the SUPPLEMENTARY INFORMATION section: SUPPLEMENTARY INFORMATION: FOR FURTHER INFORMATION CONTACT: I. Background 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 (see table 1 for Contact Person). 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 20993–0002, Phone: 301–796–9016, Email: Janie.Kim@fda.hhs.gov. Allergenic Products Advisory Committee. VerDate Sep<11>2014 19:02 Jun 09, 2016 Jkt 238001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\10JNN1.SGM 10JNN1 37609 Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Notices TABLE 1—ADVISORY COMMITTEE CONTACTS—Continued Contact person Committee/panel Shanika Craig, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1613, Silver Spring, MD 20993–0002, Phone: 301–796–6639, Email: Shanika.Craig@fda.hhs.gov. Patricio Garcia, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1611, Silver Spring, MD 20993–0002, Phone: 301–796–6875, Email: Patricio.Garcia@fda.hhs.gov. Anesthesiology and Respiratory Therapy Devices Panel. Gastroenterology and Urology Devices Panel; General and Plastic Surgery Devices Panel; Neurological Devices Panel. Ophthalmic Devices Panel. Natasha Facey, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3354, Silver Spring, MD 20993–0002, Phone: 301–796–5290, Email: Natasha.Facey@fda.hhs.gov. Evella Washington, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1535, Silver Spring, MD 20993–0002, Phone: 301–796–6683, Email: Evella.Washington@fda.hhs.gov. Cindy Hong, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2430, Silver Spring, MD 20993–0002, Phone: 301–796–0889, Email: Cindy.Hong@fda.hhs.gov. Jennifer Shepherd, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2434, Silver Spring, MD 20993–0002, Phone: 301–796–4043, Email: Jennifer.Shepherd@fda.hhs.gov. Molecular and Clinical Genetics Devices Panel. Gastrointestinal Drugs Advisory Committee. Medical Imaging Advisory Committee; Pharmaceutical Science and Clinical Pharmacology Advisory Committee. TABLE 2—COMMITTEE DESCRIPTIONS, TYPE OF CONSUMER REPRESENTATIVE VACANCY, AND APPROXIMATE Approximate date needed Type of vacancy Allergenic Products Advisory Committee—Knowledgeable in the fields of allergy, immunology, pediatrics, internal medicine, biochemistry, and related specialties. Anesthesiology and Respiratory Therapy Devices Panel—Anesthesiologists, pulmonary medicine specialists, or other experts who have specialized interests in ventilator support, pharmacology, physiology, or the effects and complications of anesthesia. Gastroenterology and Urology Devices Panel Science Advisory Board to the National Center for Toxicological Research—Knowledgeable in the fields related to toxicological research. General and Plastic Surgery Devices Panel—Surgeons (general, plastic, reconstructive, pediatric, thoracic, abdominal, pelvic and endoscopic); dermatologists; experts in biomaterials, lasers, wound healing, and quality of life; and biostatisticians. Neurological Devices Panel—Neurosurgeons (cerebrovascular and pediatric), neurologists (stroke, pediatric, pain management, and movement disorders), interventional neuroradiologists, psychiatrists, and biostatisticians. Ophthalmic Devices Panel—Ophthalmologists with expertise in corneal-external disease, vitreo-retinal surgery, glaucoma, ocular immunology, ocular pathology; optometrists; vision scientists; and ophthalmic professionals with expertise in clinical trial design, quality of life assessment, electrophysiology, low vision rehabilitation, and biostatistics. Molecular and Clinical Genetics Devices Panel—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. Gastrointestinal Drugs Advisory Committee—Knowledgeable in the fields of gastroenterology, endocrinology, surgery, clinical pharmacology, physiology, pathology, liver function, motility, esophagitis, and statistics. Medical Imaging Advisory Committee—Knowledgeable in the fields of nuclear medicine, radiology, epidemiology, statistics and related specialties. Pharmaceutical Science and Clinical Pharmacology Advisory Committee—Knowledgeable in the fields of pharmaceutical manufacturing, clinical pharmacology, pharmacokinetics, bioavailability and bioequivalence research, the design and evaluation of clinical trials, laboratory analytical techniques, pharmaceutical chemistry, physiochemistry, biochemistry, biostatistics and related biomedical and pharmacological specialties. asabaliauskas on DSK3SPTVN1PROD with NOTICES Committee/panel/areas of expertise needed 1—Voting ............... August 31, 2016. 1—Non-Voting ....... Immediately. 1—Non-Voting ....... Immediately. 1—Non-Voting ....... Immediately. 1—Non-Voting ....... Immediately. 1—Non-Voting ....... Immediately. 1—Non-Voting ....... Immediately. 1—Voting ............... June 30, 2016. 1—Voting ............... June 30, 2016. 1—Voting ............... Immediately. II. Functions and General Description of the Committee Duties A. Allergenic Products Advisory Committee Reviews and evaluates available data concerning the safety, effectiveness, and adequacy of labeling of marketed and investigational allergenic biological VerDate Sep<11>2014 19:02 Jun 09, 2016 Jkt 238001 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 product; on clinical and laboratory studies of such products; on PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 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. E:\FR\FM\10JNN1.SGM 10JNN1 37610 Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Notices asabaliauskas on DSK3SPTVN1PROD with NOTICES B. Certain Panels of the Medical Devices Advisory Committee drug products for use in the treatment of gastrointestinal diseases. 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 Federal Food, Drug, and Cosmetic 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. The Dental Products Panel also functions at times as a dental drug panel. The functions of the dental drug panel are to evaluate and recommend whether various prescription drug products should be changed to over-thecounter status and to evaluate data and make recommendations concerning the approval of new dental drug products for human use. The Medical Devices Dispute Resolution Panel provides advice to the Commissioner on complex or contested scientific issues between 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. D. Medical Imaging Advisory Committee Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in diagnostic and therapeutic procedures using radioactive pharmaceuticals and contrast media used in diagnostic radiology. C. Gastrointestinal Drugs Advisory Committee Reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human VerDate Sep<11>2014 19:02 Jun 09, 2016 Jkt 238001 E. Pharmaceutical Science and Clinical Pharmacology Advisory Committee Provide advice on scientific and technical issues concerning the safety and effectiveness of human generic drug products for use in the treatment of a broad spectrum of human diseases and, as required, any other product for which FDA has regulatory responsibility. The committee may also review Agency sponsored intramural and extramural biomedical research programs in support of FDA’s generic drug regulatory responsibilities. III. 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. IV. 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. PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 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. V. 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 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, 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 voting or nonvoting consumer representatives will not participate in the selection process. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees. E:\FR\FM\10JNN1.SGM 10JNN1 Federal Register / Vol. 81, No. 112 / Friday, June 10, 2016 / Notices Dated: June 3, 2016. Jill Hartzler Warner, Associate Commissioner for Special Medical Programs. [FR Doc. 2016–13733 Filed 6–9–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–E–2341] Determination of Regulatory Review Period for Purposes of Patent Extension; TANZEUM AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) has determined the regulatory review period for TANZEUM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product. DATES: Anyone with knowledge that any of the dates as published (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by August 9, 2016. Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period by December 7, 2016. See ‘‘Petitions’’ in the SUPPLEMENTARY INFORMATION section for more information. ADDRESSES: You may submit comments as follows: asabaliauskas on DSK3SPTVN1PROD with NOTICES SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such VerDate Sep<11>2014 19:02 Jun 09, 2016 Jkt 238001 as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2014–E–2341 For Determination of Regulatory Review Period for Purposes of Patent Extension; TANZEUM. Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION’’. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https:// www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 37611 information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.fda.gov/ regulatoryinformation/dockets/ default.htm. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301–796–3600. SUPPLEMENTARY INFORMATION: I. Background The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98–417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100–670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product’s regulatory review period forms the basis for determining the amount of extension an applicant may receive. A regulatory review period consists of two periods of time: A testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA’s determination of the E:\FR\FM\10JNN1.SGM 10JNN1

Agencies

[Federal Register Volume 81, Number 112 (Friday, June 10, 2016)]
[Notices]
[Pages 37608-37611]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13733]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-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.
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 FDA (see ADDRESSES) by July
11, 2016, for vacancies listed in this notice. Concurrently, nomination
materials for prospective candidates should be sent to FDA (see
ADDRESSES) by July 11, 2016. Nominations will be accepted for current
vacancies and for those that will or may occur through August 31, 2016.

ADDRESSES: All statements of interest from consumer organizations
interested in participating in the selection process and consumer
representative nominations should be submitted electronically to
kimberly.hamilton@fda.hhs.gov, 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: 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, 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: 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: For questions relating to
participation in the selection process: Kimberly Hamilton, Advisory
Committee Oversight and Management Staff (ACOMS), Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5103, Silver
Spring, MD 20993-0002, 301-796-8220 email:
kimberly.hamilton@fda.hhs.gov.
For questions relating to specific advisory committees or panels,
contact the appropriate Contact Person listed in table 1 in the
SUPPLEMENTARY INFORMATION section:

SUPPLEMENTARY INFORMATION:

I. Background

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 (see table 1 for Contact Person).

Table 1--Advisory Committee Contacts
------------------------------------------------------------------------
Contact person Committee/panel
------------------------------------------------------------------------
Janie Kim, Center for Biologics Evaluation Allergenic Products Advisory
and Research, Food and Drug Committee.
Administration, 10903 New Hampshire Ave.,
Bldg. 71, Rm. 6129, Silver Spring, MD
20993-0002, Phone: 301-796-9016, Email:
Janie.Kim@fda.hhs.gov.

[[Page 37609]]

Shanika Craig, Center for Devices and Anesthesiology and
Radiological Health, Food and Drug Respiratory Therapy Devices
Administration, 10903 New Hampshire Ave., Panel.
Bldg. 66, Rm. 1613, Silver Spring, MD
20993-0002, Phone: 301-796-6639, Email:
Shanika.Craig@fda.hhs.gov.
Patricio Garcia, Center for Devices and Gastroenterology and Urology
Radiological Health, Food and Drug Devices Panel; General and
Administration, 10903 New Hampshire Ave., Plastic Surgery Devices
Bldg. 66, Rm. 1611, Silver Spring, MD Panel; Neurological Devices
20993-0002, Phone: 301-796-6875, Email: Panel.
Patricio.Garcia@fda.hhs.gov.
Natasha Facey, Center for Devices and Ophthalmic Devices Panel.
Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave.,
Bldg. 32, Rm. 3354, Silver Spring, MD
20993-0002, Phone: 301-796-5290, Email:
Natasha.Facey@fda.hhs.gov.
Evella Washington, Center for Devices and Molecular and Clinical
Radiological Health, Food and Drug Genetics Devices Panel.
Administration, 10903 New Hampshire Ave.,
Bldg. 66, Rm. 1535, Silver Spring, MD
20993-0002, Phone: 301-796-6683, Email:
Evella.Washington@fda.hhs.gov.
Cindy Hong, Center for Drug Evaluation and Gastrointestinal Drugs
Research, Food and Drug Administration, Advisory Committee.
10903 New Hampshire Ave., Bldg. 31, Rm.
2430, Silver Spring, MD 20993-0002,
Phone: 301-796-0889, Email:
Cindy.Hong@fda.hhs.gov.
Jennifer Shepherd, Center for Drug Medical Imaging Advisory
Evaluation and Research, Food and Drug Committee; Pharmaceutical
Administration, 10903 New Hampshire Ave., Science and Clinical
Bldg. 31, Rm. 2434, Silver Spring, MD Pharmacology Advisory
20993-0002, Phone: 301-796-4043, Email: Committee.
Jennifer.Shepherd@fda.hhs.gov.
------------------------------------------------------------------------

Table 2--Committee Descriptions, Type of Consumer Representative
Vacancy, and Approximate
------------------------------------------------------------------------
Committee/panel/areas of Approximate date
expertise needed Type of vacancy needed
------------------------------------------------------------------------
Allergenic Products Advisory 1--Voting......... August 31, 2016.
Committee--Knowledgeable in the
fields of allergy, immunology,
pediatrics, internal medicine,
biochemistry, and related
specialties.
Anesthesiology and Respiratory 1--Non-Voting..... Immediately.
Therapy Devices Panel--
Anesthesiologists, pulmonary
medicine specialists, or other
experts who have specialized
interests in ventilator
support, pharmacology,
physiology, or the effects and
complications of anesthesia.
Gastroenterology and Urology 1--Non-Voting..... Immediately.
Devices Panel Science Advisory
Board to the National Center
for Toxicological Research--
Knowledgeable in the fields
related to toxicological
research.
General and Plastic Surgery 1--Non-Voting..... Immediately.
Devices Panel--Surgeons
(general, plastic,
reconstructive, pediatric,
thoracic, abdominal, pelvic and
endoscopic); dermatologists;
experts in biomaterials,
lasers, wound healing, and
quality of life; and
biostatisticians.
Neurological Devices Panel-- 1--Non-Voting..... Immediately.
Neurosurgeons (cerebrovascular
and pediatric), neurologists
(stroke, pediatric, pain
management, and movement
disorders), interventional
neuroradiologists,
psychiatrists, and
biostatisticians.
Ophthalmic Devices Panel-- 1--Non-Voting..... Immediately.
Ophthalmologists with expertise
in corneal-external disease,
vitreo-retinal surgery,
glaucoma, ocular immunology,
ocular pathology; optometrists;
vision scientists; and
ophthalmic professionals with
expertise in clinical trial
design, quality of life
assessment, electrophysiology,
low vision rehabilitation, and
biostatistics.
Molecular and Clinical Genetics 1--Non-Voting..... Immediately.
Devices Panel--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.
Gastrointestinal Drugs Advisory 1--Voting......... June 30, 2016.
Committee--Knowledgeable in the
fields of gastroenterology,
endocrinology, surgery,
clinical pharmacology,
physiology, pathology, liver
function, motility,
esophagitis, and statistics.
Medical Imaging Advisory 1--Voting......... June 30, 2016.
Committee--Knowledgeable in the
fields of nuclear medicine,
radiology, epidemiology,
statistics and related
specialties.
Pharmaceutical Science and 1--Voting......... Immediately.
Clinical Pharmacology Advisory
Committee--Knowledgeable in the
fields of pharmaceutical
manufacturing, clinical
pharmacology, pharmacokinetics,
bioavailability and
bioequivalence research, the
design and evaluation of
clinical trials, laboratory
analytical techniques,
pharmaceutical chemistry,
physiochemistry, biochemistry,
biostatistics and related
biomedical and pharmacological
specialties.
------------------------------------------------------------------------

II. Functions and General Description of the Committee Duties

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
product; 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.

[[Page 37610]]

B. Certain Panels of the Medical Devices Advisory 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
Federal Food, Drug, and Cosmetic 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.
The Dental Products Panel also functions at times as a dental drug
panel. The functions of the dental drug panel are to evaluate and
recommend whether various prescription drug products should be changed
to over-the-counter status and to evaluate data and make
recommendations concerning the approval of new dental drug products for
human use.
The Medical Devices Dispute Resolution Panel provides advice to the
Commissioner on complex or contested scientific issues between 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. Gastrointestinal 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 gastrointestinal diseases.

D. Medical Imaging Advisory Committee

Reviews and evaluates data concerning the safety and effectiveness
of marketed and investigational human drug products for use in
diagnostic and therapeutic procedures using radioactive pharmaceuticals
and contrast media used in diagnostic radiology.

E. Pharmaceutical Science and Clinical Pharmacology Advisory Committee

Provide advice on scientific and technical issues concerning the
safety and effectiveness of human generic drug products for use in the
treatment of a broad spectrum of human diseases and, as required, any
other product for which FDA has regulatory responsibility. The
committee may also review Agency sponsored intramural and extramural
biomedical research programs in support of FDA's generic drug
regulatory responsibilities.

III. 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.

IV. 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.

V. 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 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, 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.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

[[Page 37611]]

Dated: June 3, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-13733 Filed 6-9-16; 8:45 am]
BILLING CODE 4164-01-P

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