Request for Nominations for Voting Consumer Representative Members on Public Advisory Committees, 4582-4583 [E8-1297]

Download as PDF 4582 Federal Register / Vol. 73, No. 17 / Friday, January 25, 2008 / Notices 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 February 25, 2008. Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. 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 Carlos Pena 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/oc/advisory/ default.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: January 17, 2008. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E8–1296 Filed 1–24–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Request for Nominations for Voting Consumer Representative Members on Public Advisory Committees AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is requesting nominations for voting consumer representatives to serve on the Cellular, Tissue, and Gene Therapies Advisory Committee and the Allergenic Products Advisory Committee in the Center for Biologics Evaluation and Research (CBER). Nominations will be accepted for vacancies that will occur through August 31, 2008. DATES: Nominations will be accepted for those voting consumer representative vacancies that will occur on or before August 31, 2008. Nominations submitted on or before April 1, 2008, will be given first consideration for membership on the Cellular, Tissue, and Gene Therapies Advisory Committee and the Allergenic Products Advisory Committee. Nominations received after jlentini on PROD1PC65 with NOTICES SUMMARY: VerDate Aug<31>2005 16:59 Jan 24, 2008 Jkt 214001 April 1, 2008, will be considered for nomination to the committee should nominees still be needed. ADDRESSES: All nominations for membership should be sent electronically to CV@OC.FDA.GOV, or by mail to Advisory Committee Oversight and Management Staff (HF– 4), 5600 Fisher Lane, rm. 15A–12, Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: Regarding all nomination questions for membership, the primary contact is Gail Dapolito, Center for Biologics Evaluation and Research, 301–827– 0314, FAX: 301–827–0294, e-mail: Gail.Dapolito@fda.hhs.gov. 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/oc/advisory/default.htm. SUPPLEMENTARY INFORMATION: FDA is requesting nomination for voting consumer representative members on the following CBER committees: research programs which provide the scientific support for regulating these agents. I. Functions III. Selection Procedures A. Cellular, Tissue, and Gene Therapies Advisory Committee The committee reviews and evaluates available data relating to the safety, effectiveness, and appropriate use of human cells, human tissues, gene transfer therapies, and xenotransplantation products which are intended for a broad spectrum of human diseases and in the reconstruction, repair, or replacement of tissues for various conditions. The committee also considers the quality and relevance of FDA’s research program which provides scientific support for the regulation of these products, and makes appropriate recommendations to the Commissioner of Food and Drugs (the Commissioner). The selection of members representing consumer interests is conducted through procedures that include the use of organizations representing the public interest and consumer advocacy groups. The organizations have the responsibility of recommending candidates of the agency’s selection. B. Allergenic Products Advisory Committee The committee reviews and evaluates available data concerning the safety, effectiveness, and adequacy of labeling of marketed and investigational allergenic biological products or materials that are administered to humans for the diagnosis, prevention, or treatment of allergies and allergic disease. The committee also makes appropriate recommendations to the Commissioner on its findings regarding the affirmation or revocation of biological product licenses, the safety, effectiveness, and labeling of the products, clinical and laboratory studies of such products, amendments or revisions to regulations governing the manufacture, testing, and licensing of allergenic biological products, and on the quality and relevance of FDA’s PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 II. Criteria for Members Persons who are nominated for membership as consumer representatives on the committees must 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 must 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 committee on scientific issues that affect consumers. IV. Nomination Procedures All nominations must include a cover letter, a curriculum vitae or resume (that includes the nominee’s office address, telephone number, and e-mail address), and a list of consumer or communitybased organizations for which the candidate can demonstrate active participation. Any interested person or organization may nominate one or more qualified persons for membership to represent consumer interests on one or more of the advisory committees. Selfnominations are also accepted. FDA will ask the 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 a conflict of interest. The nomination should specify the committee(s) of interest. The term of office is up to 4 years, depending on the appointment date. FDA has a special interest in ensuring that women, minority groups, and individuals with disabilities are adequately represented on its advisory committees and, therefore, encourages nominations of qualified candidates from these groups. E:\FR\FM\25JAN1.SGM 25JAN1 Federal Register / Vol. 73, No. 17 / Friday, January 25, 2008 / Notices This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees. Dated: January 17, 2008. Randall W. Lutter, Deputy Commissioner for Policy. [FR Doc. E8–1297 Filed 1–24–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007P–0028] Determination That SEROQUEL (Quetiapine Fumarate) Tablets, 150 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. jlentini on PROD1PC65 with NOTICES ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) has determined that SEROQUEL (quetiapine fumarate) tablets, 150 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for quetiapine fumarate tablets, 150 mg, if all other legal and regulatory requirements are met. FOR FURTHER INFORMATION CONTACT: Quynh Nguyen, Center for Drug Evaluation and Research (HFD–7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–594– 2041. SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Public Law 98– 417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products approved under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the ‘‘listed drug,’’ which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). The only clinical data required in an ANDA are data to show that the drug that is the subject of the ANDA is bioequivalent to the listed drug. VerDate Aug<31>2005 16:59 Jan 24, 2008 Jkt 214001 The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the ‘‘Approved Drug Products With Therapeutic Equivalence Evaluations,’’ which is generally known as the ‘‘Orange Book.’’ Under FDA regulations, drugs are removed from the list if the agency withdraws or suspends approval of the drug’s NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (§ 314.162 (21 CFR 314.162)). Under § 314.161(a)(1) (21 CFR 314.161(a)(1)), the agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness before an ANDA that refers to that listed drug may be approved. FDA may not approve an ANDA that does not refer to a listed drug. SEROQUEL (quetiapine fumarate) tablets, 150 mg, along with the 25–mg, 50–mg, 100–mg, 200–mg, 300–mg, and 400–mg strengths, are the subject of approved NDA 20–639 held by AstraZeneca Pharmaceuticals LP (AstraZeneca). SEROQUEL (quetiapine fumarate) tablets are in a class of medications called atypical antipsychotics. Antipsychotic medicines are used to treat symptoms of schizophrenia. SEROQUEL (quetiapine fumarate) tablets may be used alone or with lithium or divalproex to treat acute manic episodes in adults who have a condition called Bipolar I Disorder. AstraZeneca obtained approval to market the 150–mg strength of SEROQUEL (quetiapine fumarate) tablets on December 20, 1998. Lachman Consultant Services, Inc., submitted a citizen petition dated January 16, 2007, (Docket No. 2007P–0028/CP1), under 21 CFR 10.30, requesting that the agency determine, as described in § 314.161, whether SEROQUEL (quetiapine fumarate) tablets, 150 mg, were withdrawn from sale for reasons of safety or effectiveness. After considering the citizen petition (including the comment(s) submitted) and reviewing agency records, the agency has determined that AstraZeneca’s SEROQUEL (quetiapine fumarate) tablets, 150 mg, were not withdrawn from sale for reasons of safety or effectiveness. AstraZeneca has never marketed SEROQUEL (quetiapine fumarate) tablets, 150 mg, in the United States, although the 150–mg tablets are marketed in some countries outside the United States. In previous instances PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 4583 (see, e.g., 67 FR 79640, December 30, 2002 (addressing a relisting request for Diazepam Autoinjector)), the agency has determined that, for purposes of §§ 314.161 and 314.162, never marketing an approved drug product in the United States is equivalent to withdrawing the drug from sale. The petitioner identified no data or other information suggesting that SEROQUEL (quetiapine fumarate) tablets, 150 mg, were withdrawn from sale as a result of safety or effectiveness concerns. AstraZeneca has marketed other strengths of SEROQUEL (quetiapine fumarate) tablets: 25 mg, 50 mg, 100 mg, 200 mg, 300 mg, and 400 mg. The agency has reviewed its files for records concerning the withdrawal of SEROQUEL (quetiapine fumarate) tablets, 150 mg. There is no indication that AstraZeneca decided not to market SEROQUEL (quetiapine fumarate) tablets, 150 mg, in the United States for safety or effectiveness reasons. FDA has independently evaluated relevant literature and data for reports of adverse events and has found no information that would indicate that SEROQUEL (quetiapine fumarate) tablets, 150 mg, were withdrawn for reasons of safety or effectiveness. FDA determines that for the reasons outlined in this document, AstraZeneca’s SEROQUEL (quetiapine fumarate) tablets, 150 mg, were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the agency will continue to list SEROQUEL (quetiapine fumarate) tablets, 150 mg, in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to SEROQUEL (quetiapine fumarate) tablets, 150 mg, may be approved by the agency as long as they meet all relevant legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for Seroquel (quetiapine fumarate) tablets, 150 mg, should be revised to meet current standards, the agency will advise ANDA applicants to submit such labeling. Dated: January 16, 2008. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E8–1298 Filed 1–24–08; 8:45 am] BILLING CODE 4160–01–S E:\FR\FM\25JAN1.SGM 25JAN1

Agencies

[Federal Register Volume 73, Number 17 (Friday, January 25, 2008)]
[Notices]
[Pages 4582-4583]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-1297]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Request for Nominations for Voting Consumer Representative 
Members on Public Advisory Committees

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is requesting 
nominations for voting consumer representatives to serve on the 
Cellular, Tissue, and Gene Therapies Advisory Committee and the 
Allergenic Products Advisory Committee in the Center for Biologics 
Evaluation and Research (CBER). Nominations will be accepted for 
vacancies that will occur through August 31, 2008.

DATES: Nominations will be accepted for those voting consumer 
representative vacancies that will occur on or before August 31, 2008. 
Nominations submitted on or before April 1, 2008, will be given first 
consideration for membership on the Cellular, Tissue, and Gene 
Therapies Advisory Committee and the Allergenic Products Advisory 
Committee. Nominations received after April 1, 2008, will be considered 
for nomination to the committee should nominees still be needed.

ADDRESSES: All nominations for membership should be sent electronically 
to CV@OC.FDA.GOV, or by mail to Advisory Committee Oversight and 
Management Staff (HF-4), 5600 Fisher Lane, rm. 15A-12, Rockville, MD 
20857.

FOR FURTHER INFORMATION CONTACT: Regarding all nomination questions for 
membership, the primary contact is Gail Dapolito, Center for Biologics 
Evaluation and Research, 301-827-0314, FAX: 301-827-0294, e-mail: 
Gail.Dapolito@fda.hhs.gov. 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/oc/advisory/default.htm.

SUPPLEMENTARY INFORMATION: FDA is requesting nomination for voting 
consumer representative members on the following CBER committees:

I. Functions

A. Cellular, Tissue, and Gene Therapies Advisory Committee

    The committee reviews and evaluates available data relating to the 
safety, effectiveness, and appropriate use of human cells, human 
tissues, gene transfer therapies, and xenotransplantation products 
which are intended for a broad spectrum of human diseases and in the 
reconstruction, repair, or replacement of tissues for various 
conditions. The committee also considers the quality and relevance of 
FDA's research program which provides scientific support for the 
regulation of these products, and makes appropriate recommendations to 
the Commissioner of Food and Drugs (the Commissioner).

B. Allergenic Products Advisory Committee

    The committee reviews and evaluates available data concerning the 
safety, effectiveness, and adequacy of labeling of marketed and 
investigational allergenic biological products or materials that are 
administered to humans for the diagnosis, prevention, or treatment of 
allergies and allergic disease. The committee also makes appropriate 
recommendations to the Commissioner on its findings regarding the 
affirmation or revocation of biological product licenses, the safety, 
effectiveness, and labeling of the products, clinical and laboratory 
studies of such products, 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 which provide the scientific support for regulating these 
agents.

II. Criteria for Members

    Persons who are nominated for membership as consumer 
representatives on the committees must 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 must 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 committee on 
scientific issues that affect consumers.

III. Selection Procedures

    The selection of members representing consumer interests is 
conducted through procedures that include the use of organizations 
representing the public interest and consumer advocacy groups. The 
organizations have the responsibility of recommending candidates of the 
agency's selection.

IV. Nomination Procedures

    All nominations must include a cover letter, a curriculum vitae or 
resume (that includes the nominee's office address, telephone number, 
and e-mail address), and a list of consumer or community-based 
organizations for which the candidate can demonstrate active 
participation. Any interested person or organization may nominate one 
or more qualified persons for membership to represent consumer 
interests on one or more of the advisory committees. Self-nominations 
are also accepted. FDA will ask the 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 a conflict of interest. The nomination should 
specify the committee(s) of interest. The term of office is up to 4 
years, depending on the appointment date.
    FDA has a special interest in ensuring that women, minority groups, 
and individuals with disabilities are adequately represented on its 
advisory committees and, therefore, encourages nominations of qualified 
candidates from these groups.

[[Page 4583]]

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

    Dated: January 17, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-1297 Filed 1-24-08; 8:45 am]
BILLING CODE 4160-01-S

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.