Training Program for Regulatory Project Managers; Information Available to Industry, 10806-10807 [2010-4924]

Download as PDF sroberts on DSKD5P82C1PROD with NOTICES 10806 Federal Register / Vol. 75, No. 45 / Tuesday, March 9, 2010 / Notices Ave., Bldg. 51, rm. 6358, Silver Spring, MD 20993–0002, 301–796–3601. 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. 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 known generally 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of the drug’s NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). Under § 314.161(a)(1) (21 CFR 314.161(a)(1)), the agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness before an ANDA that refers to that listed drug may be approved.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. DOVONEX (calcipotriene) Ointment, 0.005%, is the subject of NDA 20–273, held by LEO Pharmaceutical Products Ltd. (LEO) and initially approved on December 29, 1993. DOVONEX is indicated for the treatment of plaque psoriasis in adults. In its annual report dated February 28, 2008, LEO notified FDA that DOVONEX (calcipotriene) Ointment, 0.005%, had been discontinued, and FDA moved the drug product to the ‘‘Discontinued Drug Product List’’ section of the Orange Book. Lachman Consultant Services, Inc., submitted a citizen petition dated July 25, 2008 (Docket No. FDA–2008–P– VerDate Nov<24>2008 19:04 Mar 08, 2010 Jkt 220001 0435), under 21 CFR 10.30, requesting that the agency determine whether DOVONEX (calcipotriene) Ointment, 0.005%, was withdrawn from sale for reasons of safety or effectiveness. A second citizen petition was submitted by Mya Thomae Consulting, Inc., dated October 13, 2008 (Docket No. FDA– 2008–P–0554), requesting that the agency determine whether DOVONEX (calcipotriene) Ointment, 0.005%, was withdrawn from sale for reasons of safety or effectiveness. FDA has reviewed its records and, under § 314.161, has determined that DOVONEX (calcipotriene) Ointment, 0.005%, was not withdrawn from sale for reasons of safety or effectiveness. The petitioners identified no data or other information suggesting that DOVONEX (calcipotriene) Ointment, 0.005%, was withdrawn for reasons of safety or effectiveness. FDA has independently evaluated relevant literature and data for possible postmarketing adverse events and has found no information that would indicate that this product was withdrawn from sale for reasons of safety or effectiveness. Accordingly, the agency will continue to list DOVONEX (calcipotriene) Ointment, 0.005%, 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 DOVONEX (calcipotriene) Ointment, 0.005%, may be approved by the agency if all other legal and regulatory requirements for the approval of ANDAs are met. If FDA determines that labeling for this drug product should be revised to meet current standards, the agency will advise ANDA applicants to submit such labeling. Dated: March 3, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–4925 Filed 3–8–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0108] Training Program for Regulatory Project Managers; Information Available to Industry AGENCY: Food and Drug Administration, HHS. ACTION: PO 00000 Notice. Frm 00053 Fmt 4703 Sfmt 4703 SUMMARY: The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) is announcing the continuation of the Regulatory Project Management Site Tours and Regulatory Interaction Program (the Site Tours Program). The purpose of this document is to invite pharmaceutical companies interested in participating in this program to contact CDER. DATES: Pharmaceutical companies may submit proposed agendas to the agency by May 10, 2010 Federal Register]. FOR FURTHER INFORMATION CONTACT: Beth Duvall-Miller, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6466, Silver Spring, MD 20993–0002, 301– 796–0700, e-mail: elizabeth.duvallmiller@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background An important part of CDER’s commitment to make safe and effective drugs available to all Americans is optimizing the efficiency and quality of the drug review process. To support this primary goal, CDER has initiated various training and development programs to promote high performance in its regulatory project management staff. CDER seeks to significantly enhance review efficiency and review quality by providing the staff with a better understanding of the pharmaceutical industry and its operations. To this end, CDER is continuing its training program to give regulatory project managers the opportunity to tour pharmaceutical facilities. The goals are to provide the following: (1) First hand exposure to industry’s drug development processes and (2) a venue for sharing information about project management procedures (but not drug-specific information) with industry representatives. II. The Site Tours Program In this program, over a 2- to 3-day period, small groups (five or less) of regulatory project managers, including a senior level regulatory project manager, can observe operations of pharmaceutical manufacturing and/or packaging facilities, pathology/ toxicology laboratories, and regulatory affairs operations. Neither this tour nor any part of the program is intended as a mechanism to inspect, assess, judge, or perform a regulatory function, but is meant rather to improve mutual understanding and to provide an avenue for open dialogue. During the Site Tours Program, regulatory project managers E:\FR\FM\09MRN1.SGM 09MRN1 Federal Register / Vol. 75, No. 45 / Tuesday, March 9, 2010 / Notices will also participate in daily workshops with their industry counterparts, focusing on selective regulatory issues important to both CDER staff and industry. The primary objective of the daily workshops is to learn about the team approach to drug development, including drug discovery, preclinical evaluation, tracking mechanisms, and regulatory submission operations. The overall benefit to regulatory project managers will be exposure to project management, team techniques, and processes employed by the pharmaceutical industry. By participating in this program, the regulatory project manager will grow professionally by gaining a better understanding of industry processes and procedures III. Site Selection All travel expenses associated with the site tours will be the responsibility of CDER; therefore, selection will be based on the availability of funds and resources for each fiscal year. Selection will also be based on firms having a favorable facility status as determined by FDA’s Office of Regulatory Affairs District Offices in the firms’ respective regions. Firms interested in offering a site tour or learning more about this training opportunity should respond by (see DATES) by submitting a proposed agenda to Beth Duvall-Miller (see FOR FURTHER INFORMATION CONTACT). Dated: March 3, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES sroberts on DSKD5P82C1PROD with NOTICES National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which Jkt 220001 Dated: February 26, 2010. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2010–4586 Filed 3–8–10; 8:45 am] BILLING CODE 4140–01–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC), announces the following meeting for the aforementioned subcommittee: National Institutes of Health 19:04 Mar 08, 2010 Name of Committee: National Institute on Alcohol Abuse and Alcoholism, Special Emphasis Panel, Member Conflicts SEP. Date: April 22, 2010. Time: 12 p.m. to 2 p.m. Agenda: To review and evaluate grant applications. Place: NIAAA, 5635 Fishers, Rockville, MD 20852. Contact Person: Lorraine Gunzerath, PhD, MBA, Scientific Review Officer, National Institute on Alcohol Abuse and Alcoholism, Office of Extramural Activities, Extramural Project Review Branch, 5635 Fishers Lane, Room 2121, Bethesda, MD 20892–9304, 301– 443–2369, lgunzera@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.271, Alcohol Research Career Development Awards for Scientists and Clinicians; 93.272, Alcohol National Research Service Awards for Research Training; 93.273, Alcohol Research Programs; 93.891, Alcohol Research Center Grants; 93.701, ARRA Related Biomedical Research and Research Support Awards., National Institutes of Health, HHS) Subcommittee on Procedures Reviews (SPR), Advisory Board on Radiation and Worker Health (ABRWH), National Institute for Occupational Safety and Health (NIOSH) [FR Doc. 2010–4924 Filed 3–8–10; 8:45 am] VerDate Nov<24>2008 would constitute a clearly unwarranted invasion of personal privacy. Time and Date: 9:30 a.m.–5 p.m., March 23, 2010. Place: Cincinnati Airport Marriott, 2395 Progress Drive, Hebron, Kentucky 41018, Telephone: (859) 334–4611, Fax: (859) 334– 4619. Status: Open to the public, but without a public comment period. To access by conference call dial the following information 1(866) 659–0537, Participant Pass Code 9933701. Background: The Advisory Board was established under the Energy Employees Occupational Illness Compensation Program Act of 2000 to advise the President on a variety of policy and technical functions required to implement and effectively manage the compensation program. Key functions of the Advisory Board include PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 10807 providing advice on the development of probability of causation guidelines that have been promulgated by the Department of Health and Human Services (HHS) as a final rule; advice on methods of dose reconstruction which have also been promulgated by HHS as a final rule; advice on the scientific validity and quality of dose estimation and reconstruction efforts being performed for purposes of the compensation program; and advice on petitions to add classes of workers to the Special Exposure Cohort (SEC). In December 2000, the President delegated responsibility for funding, staffing, and operating the Advisory Board to HHS, which subsequently delegated this authority to CDC. NIOSH implements this responsibility for CDC. The charter was issued on August 3, 2001, renewed at appropriate intervals, and will expire on August 3, 2011. Purpose: The Advisory Board is charged with (a) Providing advice to the Secretary, HHS, on the development of guidelines under Executive Order 13179; (b) providing advice to the Secretary, HHS, on the scientific validity and quality of dose reconstruction efforts performed for this program; and (c) upon request by the Secretary, HHS, advise the Secretary on whether there is a class of employees at any Department of Energy facility who were exposed to radiation but for whom it is not feasible to estimate their radiation dose, and on whether there is reasonable likelihood that such radiation doses may have endangered the health of members of this class. The Subcommittee on Procedures Reviews was established to aid the Advisory Board in carrying out its duty to advise the Secretary, HHS, on dose reconstruction. It is responsible for overseeing, tracking, and participating in the reviews of all procedures used in the dose reconstruction process by the NIOSH Office of Compensation Analysis and Support (OCAS) and its dose reconstruction contractor. Matters To Be Discussed: The agenda for the Subcommittee meeting includes: the development of recommendations for an Advisory Board procedure for reviewing OCAS Program Evaluation Reports; and discussion of the following Oak Ridge Associated Universities & OCAS procedures: OTIB–013 (‘‘Special External Dose Reconstruction Considerations for Mallinckrodt Workers’’), OTIB–014 (‘‘Rocky Flats Internal Dosimetry Co-Worker Extension’’), OTIB–0029 (‘‘Internal Dosimetry Coworker Data for Y–12’’), OTIB–0049 (‘‘Estimating Doses for Plutonium Strongly Retained in the Lung’’), OTIB–0047 (External Radiation Monitoring at the Y–12 Facility During the 1948–1949 Period’’), OTIB–0051 (‘‘Effect of Threshold Energy and Angular Response of NTA Film on Missed Neutron Dose at the Oak Ridge Y–12 Facility’’), OTIB– 0054 (‘‘Fission and Activation Product Assignment for Internal Dose-Related Gross Beta and Gross Gamma Analyses’’), and OTIB–0070 (‘‘Dose Reconstruction During Residual Radioactivity Periods at Atomic Weapons Employer Facilities’’); and a continuation of the comment-resolution process for other dose reconstruction procedures under review by the Subcommittee. E:\FR\FM\09MRN1.SGM 09MRN1

Agencies

[Federal Register Volume 75, Number 45 (Tuesday, March 9, 2010)]
[Notices]
[Pages 10806-10807]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-4924]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0108]


Training Program for Regulatory Project Managers; Information 
Available to Industry

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) Center for Drug 
Evaluation and Research (CDER) is announcing the continuation of the 
Regulatory Project Management Site Tours and Regulatory Interaction 
Program (the Site Tours Program). The purpose of this document is to 
invite pharmaceutical companies interested in participating in this 
program to contact CDER.

DATES:  Pharmaceutical companies may submit proposed agendas to the 
agency by May 10, 2010 Federal Register].

FOR FURTHER INFORMATION CONTACT:  Beth Duvall-Miller, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 6466, Silver Spring, MD 20993-0002, 301-
796-0700, e-mail: elizabeth.duvallmiller@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    An important part of CDER's commitment to make safe and effective 
drugs available to all Americans is optimizing the efficiency and 
quality of the drug review process. To support this primary goal, CDER 
has initiated various training and development programs to promote high 
performance in its regulatory project management staff. CDER seeks to 
significantly enhance review efficiency and review quality by providing 
the staff with a better understanding of the pharmaceutical industry 
and its operations. To this end, CDER is continuing its training 
program to give regulatory project managers the opportunity to tour 
pharmaceutical facilities. The goals are to provide the following: (1) 
First hand exposure to industry's drug development processes and (2) a 
venue for sharing information about project management procedures (but 
not drug-specific information) with industry representatives.

II. The Site Tours Program

    In this program, over a 2- to 3-day period, small groups (five or 
less) of regulatory project managers, including a senior level 
regulatory project manager, can observe operations of pharmaceutical 
manufacturing and/or packaging facilities, pathology/toxicology 
laboratories, and regulatory affairs operations. Neither this tour nor 
any part of the program is intended as a mechanism to inspect, assess, 
judge, or perform a regulatory function, but is meant rather to improve 
mutual understanding and to provide an avenue for open dialogue. During 
the Site Tours Program, regulatory project managers

[[Page 10807]]

will also participate in daily workshops with their industry 
counterparts, focusing on selective regulatory issues important to both 
CDER staff and industry. The primary objective of the daily workshops 
is to learn about the team approach to drug development, including drug 
discovery, preclinical evaluation, tracking mechanisms, and regulatory 
submission operations. The overall benefit to regulatory project 
managers will be exposure to project management, team techniques, and 
processes employed by the pharmaceutical industry. By participating in 
this program, the regulatory project manager will grow professionally 
by gaining a better understanding of industry processes and procedures

III. Site Selection

    All travel expenses associated with the site tours will be the 
responsibility of CDER; therefore, selection will be based on the 
availability of funds and resources for each fiscal year. Selection 
will also be based on firms having a favorable facility status as 
determined by FDA's Office of Regulatory Affairs District Offices in 
the firms' respective regions. Firms interested in offering a site tour 
or learning more about this training opportunity should respond by (see 
DATES) by submitting a proposed agenda to Beth Duvall-Miller (see FOR 
FURTHER INFORMATION CONTACT).

    Dated: March 3, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-4924 Filed 3-8-10; 8:45 am]
BILLING CODE 4160-01-S

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