58606 Federal Register / Vol. 73, No. 195 / Tuesday, October 7, 2008 / Notices 

1This citizen petition was originally assigned 

docket number 94P-0199. The number was changed 

to FDA–1994–P–0017 as a result of FDA’s transition 

to its new docketing system (http:// 

www.Regulations.gov) in January 2008. 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2004–P–0474] (formerly 

Docket No. 2004P–0262) 

Withdrawal of Approval of 128 

Suitability Petitions; Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

notice that appeared in the Federal 

Register of February 23, 2007 (72 FR 

8184). The notice announced that FDA 

was withdrawing approval of 128 

suitability petitions in accordance with 

the Pediatric Research Equity Act of 

2003 (PREA). FDA has determined that 

approval of the suitability petition 

submitted by Roxane Laboratories, Inc. 

(Roxane), for lorazepam oral solution, 1 

milligram (mg)/10 milliliters (mL) 

(Docket No. FDA–1994–P–0017),1

should not have been withdrawn and 

therefore retroactively reinstates its 

approval of that petition. This document 

also corrects errors in the petition 

numbers for two of the suitability 

petitions listed in the notice. 

FOR FURTHER INFORMATION CONTACT: 

Cecelia M. Parise,Center for Drug 

Evaluation and Research (HFD–600), 

Food and Drug Administration,5600 

Fishers Lane, Rockville, MD 20857, 

301–827–5845. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of February 23, 2007 

(72 FR 8184), FDA announced that it 

was withdrawing approval of 128 

suitability petitions in accordance with 

PREA. Prior to PREA’s enactment, FDA 

had approved these suitability petitions 

to permit abbreviated new drug 

applications (ANDAs) to be submitted 

for drugs that had a different active 

ingredient, dosage form, or route of 

administration than their reference 

listed drugs. In the notice, FDA 

explained that the approval of these 

suitability petitions was being 

withdrawn because ANDAs were never 

submitted and PREA requires that all 

applications submitted on or after April 

1, 1999, for a new active ingredient, new 

indication, new dosage form, new 

dosing regimen, or new route of 

administration contain an assessment of 

the safety and effectiveness of the drug 

for the claimed indications in relevant 

pediatric subpopulations unless the 

requirement is waived or deferred. 

Thus, these suitability petitions no 

longer satisfied the conditions for 

approval. The notice became effective 

on March 26, 2007. 

In response to the notice, Roxane sent 

FDA a letter dated March 1, 2007, 

regarding the withdrawal of approval of 

its suitability petition for lorazepam oral 

solution, 1 mg/10 mL (Docket No. FDA– 

1994–P–0017). Roxane stated that it 

submitted ANDA 74–648 for lorazepam 

oral solution, 1 mg/10 mL, on the basis 

of the approval of its suitability petition 

for lorazepam oral solution, 1 mg/10 mL 

(Docket No. FDA–1994–P–0017). 

Roxane also stated that during the 

review of the ANDA, they were asked to 

change the name of the product to 

lorazepam oral solution, 0.5 mg/5 mL, 

and the ANDA was approved on March 

18, 1997. FDA has reviewed its records 

and determined that ANDA 74–648 was 

submitted under suitability petition no. 

94P–0199/CP1 before April 1, 1999; 

therefore, approval of this suitability 

petition should not have been 

withdrawn. This document corrects the 

error and retroactively reinstates 

approval of the suitability petition for 

lorazepam oral solution, 1 mg/10 mL 

(Docket No. FDA–1994–P–0017). 

In addition, FDA has determined that 

the notice contained incorrect petition 

numbers for two of the suitability 

petitions. This document corrects those 

errors. 

In FR Doc. E7–3043, appearing on 

page 8184 in the Federal Register of 

Friday, February 23, 2007, the following 

corrections are made: 

1. On page 8185, in the table, in the 

first column, for Petition No., ‘‘85P– 

0095/CP1’’ is corrected to read ‘‘83N– 

0095/CP1’’. 

2. On page 8187, in the table, in the 

first column, for Petition No., ‘‘92P– 

0332/CP1’’ is corrected to read ‘‘92P– 

0232/CP1’’. 

3. On page 8187, in the table, in the 

first column, for Petition No., ‘‘94P– 

0199/CP1’’ is deleted. 

Dated: September 29, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–23721 Filed 10–6–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Request for Public Comment: 60-Day 

Proposed Information Collection: 

Indian Health Service Background 

Investigations of Individuals in 

Positions Involving Regular Contact 

With or Control Over Indian Children, 

OPM-306 

Correction 

In notice document E8–22359 

beginning on page 55122 in the issue 

ofWednesday, September 24, 2008, 

make the following corrections: 

1. On page 55122, in the third 

column, in the second full paragraph, in 

the 12th line ‘‘IRS’’ should read ‘‘IHS’’. 

2. On page 55123, in the first column, 

in the third full paragraph, seven lines 

from the bottom ‘‘IRS’’ should read 

‘‘IHS’’. 

[FR Doc. Z8–22359 Filed 10–6–08; 8:45 am] 

BILLING CODE 1505–01–D 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Amended 

Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the Center for Scientific 

Review Special Emphasis Panel, 

October 23, 2008, 8 a.m. to October 24, 

2008, 5 p.m., Holiday Inn Express Hotel 

and Suites, San Francisco Fisherman’s 

Wharf, 550 North Point Street, San 

Francisco, CA, 91433 which was 

published in the Federal Register on 

September 19, 2008, 73 FR 54408– 

54411. 

The meeting will be held October 22, 

2008, 6 p.m. to October 23, 2008, 8 p.m. 

The meeting location remains the same. 

The meeting is closed to the public. 

Dated: September 30, 2008. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E8–23594 Filed 10–6–08; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

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