Federal Register / Vol. 74, No. 157 / Monday, August 17, 2009 / Notices 41437 

warranted, to provide advice on these 

issues. The draft meeting agenda and 

other information about SACGHS, 

including information about access to 

the Web cast, will be available at the 

following Web site: http:// 

oba.od.nih.gov/SACGHS/ 

sacghs_meetings.html. 

Dated: August 10, 2009. 

Jennifer Spaeth, 

Director, NIH Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–19584 Filed 8–14–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Sterilization of Persons in Federally 

Assisted Family Planning Projects 

(July 17, 2009); Correction 

AGENCY: Department of Health and 

Human Services. 

ACTION: Notice: correction. 

SUMMARY: The Department of Health and 

Human Services (HHS) published a 

document in the Federal Register of 

July 17, 2009, requesting OMB 

reauthorization of the form 

‘‘Sterilization of Persons in Federally 

Assisted Family Planning Projects.’’ The 

document contained an incorrect 

citation to the HHS sterilization 

regulations; incorrectly identified the 

Office of Population Affairs (OPA), 

rather than the Public Health Service 

(PHS), as the agency within HHS that 

administers programs of health services 

which are supported by Federal 

financial assistance and which are 

required to obtain informed consent 

from persons undergoing sterilizations; 

incorrectly described the form that is 

required to be used to obtain informed 

consent; and incorrectly referred to the 

regulations to which the consent form is 

appended as OPA regulations rather 

than PHS regulations. 

FOR FURTHER INFORMATION CONTACT: 

Sherette Funn-Coleman, 202–690–5683. 

Corrections: 

In the Federal Register of July 17, 

2009, in FR Doc. OS–0937–0166, on 

page 34757, in the second column, 

correct the citation to the sterilization 

regulations to read: 

Proposed Project: HHS 42 CFR part 

50, subpart B; Sterilization of Persons in 

Federally Assisted Family Planning 

Projects— 

In the third column, correct the 

‘‘Abstract’’ related to the consent form 

to read as follows: 

The consent form solicits information 

to assure voluntary and informed 

consent to persons undergoing 

sterilization in programs of health 

services which are supported by Federal 

financial assistance administered by the 

Public Health Service (PHS). The form 

provides additional procedural 

protections to individuals undergoing 

sterilization. In order to obtain informed 

consent, the regulation requires that 

programs use either the form that is 

appended to the PHS regulation or 

another consent form approved by the 

Secretary. 

Dated: August 7, 2009. 

Seleda Perryman, 

Office of the Secretary, Paperwork Reduction 

Act Reports Clearance Officer. 

[FR Doc. E9–19566 Filed 8–14–09; 8:45 am] 

BILLING CODE 4150–34–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–P–0443] 

Determination That DEMADEX 

(Torsemide) Injection, 20 Milligrams/2 

Milliliter (10 Milligrams/Milliliter) and 50 

Milligrams/5 Milliliter (10 Milligrams/ 

Milliliter), 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) is announcing its 

determination that DEMADEX 

(torsemide) injection, 20 milligrams 

(mg)/2 milliliter (mL) (10 mg/mL) and 

50 mg/5 mL (10 mg/mL), was not 

withdrawn from sale for reasons of 

safety or effectiveness. This 

determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for torsemide 

injection, 20 mg/2mL (10 mg/mL) and 

50 mg/5 mL (10 mg/mL), if all other 

legal and regulatory requirements are 

met. 

FOR FURTHER INFORMATION CONTACT: 

Nikki Mueller, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6312, 

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. 

PharmaForce, Inc., submitted a citizen 

petition dated August 5, 2008 (Docket 

No. FDA–2008–P–0443), under 21 CFR 

10.30 requesting that the agency 

determine whether DEMADEX 

(torsemide) injection, 20 mg/2 mL (10 

mg/mL) and 50 mg/5 mL (10 mg/mL), 

was withdrawn from sale for reasons of 

safety or effectiveness. DEMADEX 

(torsemide) injection is the subject of 

NDA 20–137, held by Roche 

Pharmaceuticals (Roche) and was 

initially approved on August 23, 1993. 

DEMADEX is indicated for the 

treatment of edema associated with 

congestive heart failure, renal disease, 

or hepatic disease. Roche notified FDA 

on June 16, 2008, that it was no longer 

marketing DEMADEX (torsemide) 

injection, 20 mg/2 mL (10 mg/mL) and 

50 mg/5 mL (10 mg/mL), and the drug 

product was moved to the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. 

FDA has reviewed its records and, 

under § 314.161, has determined that 

DEMADEX (torsemide) injection, 20 mg/ 

2 mL (10 mg/mL) and 50 mg/5 mL (10 

mstockstill on DSKH9S0YB1PROD with NOTICES