Federal Register / Vol. 74, No. 70 / Tuesday, April 14, 2009 / Notices 17195 

ACTION: Notice of Non-competitive 

Replacement Award. 

SUMMARY: The Health Resources and 

Services Administration (HRSA) is 

issuing a temporary non-competitive 

replacement award to the National 

Jewish Hospital and Research Center to 

avoid disruption and continue outreach, 

medical screening and referral services 

to former uranium mine workers and 

individuals in the states of Colorado, 

Wyoming and portions of Southeastern 

Utah exposed to radioactive fallout 

during prior testing of nuclear weapons. 

SUPPLEMENTARY INFORMATION: 

Intended Recipient of the Award: 

National Jewish Hospital and Research 

Center in Denver, Colorado. 

Amount of the Award: $120,106.00 

(an 8-month supplement, January 1, 

2009, through August 31, 2009) to 

ensure ongoing services to the target 

populations. 

Project Period: The period of 

supplemental support is from January 1, 

2009, to August 31, 2009. 

Authority: This activity is under the 

authority of the Public Health Service Act, 

Section 417C of Public Law 106–245. 

Catalogue of Federal Domestic 

Assistance Number: 93.257 

Justication for the Exception to 

Competition: Critical funding for 

outreach, medical screening and referral 

services to the target populations in 

Colorado, Wyoming and portions of 

Southeastern Utah will be continued 

through a temporary, non-competitive 

replacement award to the National 

Jewish Hospital and Research Center 

(NJHRC) as the new recipient. This 

temporary award is needed because the 

former grantee, St. Mary’s Hospital and 

Medical Center, relinquished, effective 

December 31, 2008, the original award 

(project period September 1, 2008, 

through August 31, 2011). NJHRC, 

nationally known as the ‘‘Center for 

Research and Treatment of Respiratory 

Conditions,’’ is uniquely qualified to 

provide screening and diagnosis of 

occupationally related radiogenic 

diseases for the target populations. 

NJHRC has administered the HRSAfunded Black Lung Clinic Program 

(BLCP) grant for the past five years and 

is well suited to undertake operations of 

the Radiation Exposure Screening and 

Education Program under the previously 

approved scope of project. Additionally, 

this organization has a thorough 

understanding of the characteristics and 

needs of miners (both current and 

retired) as well as other workers at risk 

for occupational diseases. HRSA’s 

Office of Rural Health Policy is not 

aware of any other organization that 

could provide such treatment and 

services to the impacted service 

populations without additional time 

and resources being devoted to bringing 

that organization’s service capacity up 

to the level needed under the project 

scope of this award. 

This temporary non-competitive 

replacement award will permit the new 

recipient to ensure continuity of 

services to the affected populations. The 

supplemental funding will provide 

support for 8 months. Further funding 

beyond August 31, 2009, for this service 

area will be provided through a limited 

service area competition to be 

announced in the near future. 

FOR FURTHER INFORMATION CONTACT: Tom 

Morris, Associate Administrator, Office 

of Rural Health Policy, Health Resources 

and Services Administration, 5600 

Fishers Lane, Rockville, MD 20857; 

phone 301–443–0835; 

tmorris@hrsa.hhs.gov. 

Dated: April 9, 2009. 

Marcia K. Brand, 

Deputy Administrator. 

[FR Doc. E9–8442 Filed 4–13–09; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Environmental 

Health Sciences, Division of 

Extramural Research and Training; 

Proposed Collection; Comment 

Request Hazardous Waste Worker 

Training 

SUMMARY: In compliance with the 

requirement of Section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

National Institute of Environmental 

Health Sciences (NIEHS), the National 

Institutes of Health (NIH) will publish 

periodic summaries of proposed 

projects to be submitted to the Office of 

Management and Budget (OMB) for 

review and approval. 

Proposed Collection: Title: Hazardous 

Waste Worker Training—42 CFR part 

65. Type of Information Collection 

Request: Revision of OMB No. 0925– 

0348 and expiration date September 30, 

2009. Need and Use of Information 

Collection: This request for OMB review 

and approval of the information 

collection is required by regulation 42 

CFR part 65(a)(6). The National Institute 

of Environmental Health Sciences 

(NIEHS) was given major responsibility 

for initiating a worker safety and health 

training program under Section 126 of 

the Superfund Amendments and 

Reauthorization Act of 1986 (SARA) for 

hazardous waste workers and 

emergency responders. A network of 

non-profit organizations that are 

committed to protecting workers and 

their communities by delivering highquality, peer-reviewed safety and health 

curricula to target populations of 

hazardous waste workers and 

emergency responders has been 

developed. In twenty-one years (FY 

1987–2008), the NIEHS Worker Training 

program has successfully supported 20 

primary grantees that have trained more 

than 2.2 million workers across the 

country and presented over 130,250 

classroom and hands-on training 

courses, which have accounted for 

nearly 30 million contact hours of actual 

training. Generally, the grant will 

initially be for one year, and subsequent 

continuation awards are also for one 

year at a time. Grantees must submit a 

separate application to have the support 

continued for each subsequent year. 

Grantees are to provide information in 

accordance with S65.4(a), (b), (c) and 

65.6(a) on the nature, duration, and 

purpose of the training, selection 

criteria for trainees’ qualifications and 

competency of the project director and 

staff, cooperative agreements in the case 

of joint applications, the adequacy of 

training plans and resources, including 

budget and curriculum, and response to 

meeting training criteria in OSHA’s 

Hazardous Waste Operations and 

Emergency Response Regulations (29 

CFR 1910.120). As a cooperative 

agreement, there are additional 

requirements for the progress report 

section of the application. Grantees are 

to provide their information in hard 

copy as well as enter information into 

the WETP Grantee Data Management 

System. The information collected is 

used by the Director through officers, 

employees, experts, and consultants to 

evaluate applications based on technical 

merit to determine whether to make 

awards. Frequency of Response: 

Biannual. Affected Public: Non-profit 

organizations. Type of Respondents: 

Grantees. The annual reporting burden 

is as follows: Estimated Number of 

Respondents: 18; Estimated Number of 

Responses per Respondent: 2; Average 

Burden Hours per Response: 14; and 

Estimated Total Annual Burden Hours 

Requested: 504. The annualized cost to 

respondents is estimated at: $16,380. 

There are no Capital Costs, Operating 

Costs and/or Maintenance Costs to 

report. 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies should 

17196 Federal Register / Vol. 74, No. 70 / Tuesday, April 14, 2009 / Notices 

address one or more of the following 

points: (1) Evaluate whether the 

proposed collection of information is 

necessary for the proper performance of 

the function of the agency, including 

whether the information will have 

practical utility; (2) Evaluate the 

accuracy of the agency’s estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(3) Enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) Minimize the burden 

of the collection of information on those 

who are to respond, including the use 

of appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and 

instruments, contact: Joseph T. Hughes, 

Jr., Director, Worker Education and 

Training Branch, Division of Extramural 

Research and Training, NIEHS, P.O. Box 

12233, Research Triangle Park, NC 

27709 or call non-toll-free number (919) 

541–0217 or E-mail your request, 

including your address to 

wetp@niehs.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60-days of the date of 

this publication. 

Dated: April 2, 2009. 

Marc S. Hollander, 

NIEHS Associate Director for Management. 

[FR Doc. E9–8472 Filed 4–13–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–P–0250] (formerly 

Docket No. 2007P–0341) 

Determination That ZOMETA 

(Zoledronic Acid for Injection), 

Equivalent to 4 Milligrams Base Per 

Vial, Lyophilized Powder for Injection, 

Was Not Withdrawn From Sale for 

Reasons of Safety or Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

that ZOMETA (zoledronic acid for 

injection), equivalent to (EQ) 4 

milligrams (mg) base/vial, lyophilized 

powder for injection, was not 

withdrawn from sale for reasons of 

safety or effectiveness. This 

determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for zoledronic 

acid lyophilized powder for injection, 4- 

mg base/vial. 

FOR FURTHER INFORMATION CONTACT: 

Nancy Boocker, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6244, 

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 

sponsors 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. Sponsors of 

ANDAs 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 generally known as the 

‘‘Orange Book.’’ Under FDA regulations, 

drugs are withdrawn 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 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. 

ZOMETA (zoledronic acid for 

injection), EQ 4-mg base/vial, 

lyophilized powder for injection, is the 

subject of approved NDA 21–223 held 

by Novartis Pharmaceuticals Corp. 

(Novartis). Zoledronic acid, lyophilized 

powder for injection, EQ 4-mg base/vial, 

is indicated for treatment of 

hypercalcemia of malignancy. It also is 

indicated for the treatment of patients 

with multiple myeloma and patients 

with documented bone metastases from 

solid tumors, in conjunction with 

standard antineoplastic therapy. 

Novartis ceased manufacturing 

ZOMETA (zoledronic acid for injection), 

EQ 4 mg-base/vial, lyophilized powder 

for injection, in May 2003. On 

September 13, 2007, Kendle 

International, on behalf of Sun 

Pharmaceutical Industries Ltd., 

submitted a citizen petition (Docket No. 

2007P–0341/CP1), under 21 CFR 10.30, 

requesting that the agency determine 

whether zoledronic acid lyophilized 

powder for injection, EQ 4-mg base/vial, 

was withdrawn from sale for reasons of 

safety or effectiveness. 

The agency has determined that 

ZOMETA (zoledronic acid for injection), 

EQ 4-mg base/vial, lyophilized powder 

for injection, was not withdrawn from 

sale for reasons of safety or 

effectiveness. The petitioner has 

identified no data or other information 

suggesting that zoledronic acid 

lyophilized powder for injection, 4-mg 

base/vial, was withdrawn from sale as a 

result of safety or effectiveness 

concerns. FDA’s independent 

evaluation of relevant information has 

uncovered no information that would 

indicate this product was withdrawn for 

reasons of safety or effectiveness. 

After considering the citizen petition 

and reviewing agency records, FDA 

determines that for the reasons outlined 

previously, ZOMETA (zoledronic acid 

for injection), EQ 4-mg base/vial, 

lyophilized powder for injection, was 

not withdrawn from sale for reasons of 

safety or effectiveness. Accordingly, the 

agency will continue to list ZOMETA 

(zoledronic acid for injection), 4-mg 

base/vial, lyophilized powder for 

injection, 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 ZOMETA 

(zoledronic acid for injection), EQ 4-mg 

base/vial, lyophilized powder for 

injection, 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 the labeling of this drug 

product should be revised to meet 

current standards, the agency will 

advise ANDA applicants to submit such 

labeling.