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withdrawn from sale for reasons of 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withdrawn from sale for reasons of 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– 

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: 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 


sroberts on DSKD5P82C1PROD with NOTICES
Federal Register / Vol. 75, No. 45 / Tuesday, March 9, 2010 / Notices 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

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 

would constitute a clearly unwarranted 

invasion of personal privacy. 

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) 

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 

Subcommittee on Procedures Reviews 

(SPR), Advisory Board on Radiation 

and Worker Health (ABRWH), National 

Institute for Occupational Safety and 

Health (NIOSH) 

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: 

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 

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. 


sroberts on DSKD5P82C1PROD with NOTICES