23412 Federal Register / Vol. 74, No. 95 / Tuesday, May 19, 2009 / Notices 

Application No. Drug Applicant 

ANDA 76–476 Benazepril HCl Tablets, 5 mg, 10 mg, 20 mg, and 40 mg Mylan Pharmaceuticals, Inc. 

ANDA 76–489 Anagrelide HCl Capsules, 0.5 mg and 1 mg Roxane Laboratories, Inc. 

ANDA 77–249 Oxandrolone Tablets USP, 2.5 mg and 10 mg Do. 

ANDA 77–445 Polyethylene Glycol 3350 Powder for Oral Solution Teva Pharmaceuticals USA, 1090 Horsham Rd., P.O. 

Box 1090, North Wales, PA 19454 

ANDA 77–648 Zonisamide Capsules, 25 mg, 50 mg, and 100 mg Roxane Laboratories, Inc. 

ANDA 78–026 Paroxetine Tablets USP, 10 mg, 20 mg, 30 mg, and 40 

mg 

Do. 

ANDA 81–008 Strifon Forte DSC (chlorzoxazone tablets USP), 500 mg Ferndale Laboratories, 780 West 8th Mile Rd., Ferndale, 

MI 48220 

ANDA 81–095 Acetaminophen, Aspirin, and Codeine Phosphate Capsules, 150 mg/180 mg/15 mg Mikart, Inc., 1750 Chattahoochee Ave., Atlanta, GA 

30318 

ANDA 83–283 Isoproterenol HCl Injection USP, 0.02 mg/mL Hospira, Inc. 

ANDA 83–838 Promethazine HCl Injection USP Do. 

ANDA 84–074 Bethanechol Chloride Tablets USP, 25 mg Lannett Co., Inc., 9000 State Rd., Philadelphia, PA 

19136 

ANDA 84–702 Bethanechol Chloride Tablets USP, 5 mg Do. 

ANDA 84–712 Bethanechol Chloride Tablets USP, 10 mg Do. 

ANDA 84–735 Apresazide (hydralazine HCl and hydrochlorothiazide) 

Capsules, 25 mg/25 mg 

Novartis Pharmaceuticals Corp. 

ANDA 84–810 Apresazide (hydralazine HCl and hydrochlorothiazide) 

Capsules, 50 mg/50 mg 

Do. 

ANDA 86–366 Acetaminophen and Codeine Phosphate Oral Solution 

USP, 120 mg/12 mg per 5 mL 

Roxane Laboratories, Inc. 

ANDA 87–563 Quibron-T/SR (theophylline) Extended-Release Tablets, 

300 mg 

Monarch Pharmaceuticals, Inc. 

ANDA 88–126 Aminophylline Oral Solution USP, 105 mg/5 mL Roxane Laboratories, Inc. 

ANDA 88–656 Quibron-T (theophylline) Tablets, 300 mg Monarch Pharmaceuticals, Inc. 

ANDA 89–650 Lidocaine HCl and Epinephrine Injection USP Hospira, Inc. 

Therefore, under section 505(e) of the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 355(e)) and under authority 

delegated to the Director, Center for 

Drug Evaluation and Research, by the 

Commissioner of Food and Drugs, 

approval of the applications listed in the 

table in this document, and all 

amendments and supplements thereto, 

is hereby withdrawn, effective June 18, 

2009. 

Dated: April 30, 2009. 

Douglas C. Throckmorton, 

Deputy Director, Center for Drug Evaluation 

and Research. 

[FR Doc. E9–11628 Filed 5–18–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

Title: Annual Survey of Refugees 

(Form ORR–9). 

OMB No.: 0970–0033. 

Description: The Annual Survey of 

Refugees collects information on the 

social and economic circumstances of a 

random sample of refugees, Amerasians, 

and entrants who arrived in the United 

States in the five years prior to the date 

of the survey. The survey focuses on the 

refugees training, labor force 

participation, and welfare utilization 

rates. Dates are segmented by region of 

origin, State of resettlement, and 

number of months since arrival. From 

the responses, the Office of Refugee 

Resettlement reports on the economic 

adjustment of refugees to the American 

economy. These data are used by 

Congress in its annual deliberations for 

refugee admissions and funding and by 

program managers in formulating 

policies for the future direction of the 

Refugee Resettlement Program. 

Respondents: Refugees, entrants, 

Amerasians, and Havana parolees. 

mstockstill on PROD1PC66 with NOTICES

Federal Register / Vol. 74, No. 95 / Tuesday, May 19, 2009 / Notices 23413 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses 

per 

respondent 

Average 

burden 

hours per 

response 

Total 

burden 

hours 

ORR–9 Annual Survey of Refugees ............................................................................... 2,000 1 0.63 1,253.20 

Request for Participation Letter ....................................................................................... 2,000 1 0.04 80 

Estimated Total Annual Burden 

Hours: 1,333.20 

Additional Information 

Copies of the proposed collection may 

be obtained by writing to the 

Administration for Children and 

Families, Office of Administration, 

Office of Information Services, 370 

L’Enfant Promenade, SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. All requests should be 

identified by the title of the information 

collection. E-mail address: 

infocollection@acf.hhs.gov. 

OMB Comment 

OMB is required to make a decision 

concerning the collection of information 

between 30 and 60 days after 

publication of this document in the 

Federal Register. Therefore, a comment 

is best assured of having its full effect 

if OMB receives it within 30 days of 

publication. Written comments and 

recommendations for the proposed 

information collection should be sent 

directly to the following: Office of 

Management and Budget, Paperwork 

Reduction Project, Fax: 202–395–7245, 

Attn: Desk Officer for the 

Administration for Children and 

Families. 

Dated: May 14, 2009. 

Janean Chambers, 

Reports Clearance Officer. 

[FR Doc. E9–11606 Filed 5–18–09; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0075] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Medical Device 

Reporting: Manufacturer, Importer, 

User Facility, and Distributor Reporting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995 

(the PRA). 

DATES: Fax written comments on the 

collection of information by June 18, 

2009. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–6974, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0437. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr., Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3793. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Medical Device Reporting: 

Manufacturer, Importer, User Facility, 

and Distributor Reporting—21 CFR Part 

803 (OMB Control Number 0910– 

0437)—Extension 

Section 519(a)(1) of Federal Food, 

Drug, and Cosmetic Act (the act) (21 

U.S.C. 360i(a)(1)) requires every 

manufacturer or importer to report 

‘‘whenever the manufacturer or 

importer receives or otherwise becomes 

aware of information that reasonably 

suggests that one of its marketed 

devices: (A) May have caused or 

contributed to a death or serious injury, 

or (B) has malfunctioned and that such 

device or a similar device marketed by 

the manufacturer or importer would be 

likely to cause or contribute to a death 

or serious injury if the malfunction were 

to recur * * *.’’ 

Section 519(b)(1)(A) of the act 

requires ‘‘whenever a device user 

facility receives or otherwise becomes 

aware of information that reasonably 

suggests that a device has or may have 

caused or contributed to the death of a 

patient of the facility, the facility shall, 

as soon as practicable but not later than 

10 working days after becoming aware 

of the information, report the 

information to the Secretary and, if the 

identity of the manufacturer is known, 

to the manufacturer of the device.’’ 

Section 519(b)(1)(B) of the act requires 

‘‘whenever a device user facility 

receives or otherwise becomes aware of: 

(i) information that reasonably suggests 

that a device has or may have caused or 

contributed to the serious illness of, or 

serious injury to, a patient of the facility 

* * *, shall, as soon as practicable but 

not later than 10 working days after 

becoming aware of the information, 

report the information to the 

manufacturer of the device or to the 

Secretary if the identity of the 

manufacturer is not known.’’ 

Complete, accurate, and timely 

adverse event information is necessary 

for the identification of emerging device 

problems. Information from these 

reports will be used to evaluate risks 

associated with medical devices which 

will enable FDA to take appropriate 

regulatory measures in protection of the 

public health under section 519 of the 

act. Thus FDA is requesting approval for 

these information collection 

requirements which are being 

implemented under part 803 (21 CFR 

part 803). 

Respondents to this collection of 

information are businesses or other for 

profit and nonprofit organizations 

including user facilities, manufacturers, 

and importers of medical devices. 

In the Federal Register of February 

25, 2009 (74 FR 8547), FDA published 

a 60-day notice requesting public 

comment on the information collection 

provisions. FDA received one nonrelated PRA comment that did not 

require a response. 

FDA estimates the burden of this 

collection of information as follows: 

mstockstill on PROD1PC66 with NOTICES