Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Notices 57109 

or condition; and (3) will not expose 

patients to an unreasonable or 

significant risk of illness or injury with 

the probable benefit to health from 

using the device outweighing the risk of 

injury or illness from its use. This takes 

into account the probable risks and 

benefits of currently available devices or 

alternative forms of treatment. 

The information collected will assist 

FDA in making determinations on the 

following: (1) Whether to grant HUD 

designation of a medical device; (2) 

exempt a HUD from the effectiveness 

requirements under sections 514 and 

515 of the act, provided that the device 

meets requirements set forth under 

section 520(m) of the act; and (3) 

whether to grant marketing approval(s) 

for the HUD. Failure to collect this 

information would prevent FDA from 

making a determination on the factors 

listed previously in this document. 

Further, the collected information 

would also enable FDA to determine 

whether the holder of a HUD is in 

compliance with the HUD provisions 

under section 520(m) of the act. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of Respondents Annual Frequency per 

Response 

Total Annual Responses Hours per Response Total Hours 

814.102 14 1 14 40 560 

814.104 6 1 6 320 1,920 

814.106 6 2 12 50 600 

814.108 32 1 32 80 2,560 

814.116(e)(3) 1 1 1 1 1 

814.124(a) 5 1 5 1 5 

814.24(b) 4 1 4 2 8 

814.126(b)(1) 45 1 45 120 5,400 

Total 11,054 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of Recordkeepers Annual Frequency per 

Recordkeeping Total Annual Records Hours per Record Total Hours 

814.126(b)(2) 45 1 45 2 90 

Total 90 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

The number of respondents in Tables 

1 and 2 of this document are an average 

from data for the previous 3 years, i.e., 

FY 2005–2007. The number of annual 

reports submitted under § 814.126(b)(1) 

in Table 1 reflects an increase to 45 

respondents with approved HUD 

applications. Likewise, under 

§ 814.126(b)(2) in Table 2, the number of 

recordkeepers increased to 45. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

Dated: September 25, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–22991 Filed 9–30–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0506] 

Determination That ATROVENT 

(Ipatropium Bromide) Inhalation 

Solution and 10 Other Drug Products 

Were 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 the 11 drug products listed in this 

document were not withdrawn from 

sale for reasons of safety or 

effectiveness. This determination means 

that FDA will not begin procedures to 

withdraw approval of abbreviated new 

drug applications (ANDAs) that refer to 

these drug products, and it will allow 

FDA to continue to approve ANDAs that 

refer to the products as long as they 

meet relevant legal and regulatory 

requirements. 

FOR FURTHER INFORMATION CONTACT: 

Olivia Pritzlaff, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6308, 

Silver Spring, MD 20993–0002, 301– 

796–3601. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 


jlentini on PROD1PC65 with NOTICES
57110 Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Notices 

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 (the 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, 

a drug is 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 § 314.161(a) (21 CFR 

314.161(a)), the agency must determine 

whether a listed drug was withdrawn 

from sale for reasons of safety or 

effectiveness: (1) Before an ANDA that 

refers to that listed drug may be 

approved; (2) whenever a listed drug is 

voluntarily withdrawn from sale and 

ANDAs that refer to the listed drug have 

been approved; and (3) when a person 

petitions for such a determination under 

21 CFR § 10.25(a) and § 10.30. Section 

314.161(d) provides that if FDA 

determines that a listed drug was 

withdrawn from sale for reasons of 

safety or effectiveness, the agency will 

initiate proceedings that could result in 

the withdrawal of approval of the 

ANDAs that refer to the listed drug. 

FDA has become aware that the drug 

products listed in the table in this 

document are no longer being marketed. 

(As requested by the applicant, FDA 

withdrew approval of NDA 20–228 for 

ATROVENT (ipratropium bromide) 

Inhalation Solution in the Federal 

Register of November 7, 2007 (72 FR 

62858).) 

Application No. Drug Applicant 

NDA 20–228 ATROVENT (ipratropium bromide) Inhalation 

Solution, 0.02% 

Boehringer Ingelheim Pharmaceuticals, Inc., 

900 Ridgebury Rd., P.O. Box 368, 

Ridgefield, CT 06877–0368 

NDA 20–306 Fludeoxyglucose F–18 (4–40 millicuries 

(mCi)/milliliter (mL) and 4–90 mCi/mL) Injection 

Downstate Clinical PET Center, Methodist 

Medical Center, 112 Crescent Ave., Peoria, 

IL 61606 

NDA 20–333 AGRYLIN (anagrelide hydrochloride (HCl)) 

Capsules, equivalent to (EQ) 1 milligram 

(mg) base 

Shire US Inc., 725 Chesterbrook Blvd., 

Wayne, PA 19087–5637 

NDA 20–377 CORDARONE (amiodarone HCl) Injection, 50 

mg/mL 

Wyeth Pharmaceuticals, P.O. Box 8299, 

Philadelphia, PA 19101–8299 

NDA 20–974 PROZAC (fluoxetine HCl) Tablets, EQ 10 mg 

base 

Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285 

NDA 50–417 NEOSPORIN (bacitracin zinc; neomycin sulfate; polymyxin B sulfate) Ophthalmic Ointment, 400 units/gram (g); EQ 3.5 mg base/ 

g; 10,000 units/g 

Monarch Pharmaceuticals, Inc., c/o King 

Pharmaceuticals, Inc., 501 Fifth St., Bristol, 

TN 37620 

NDA 50–461 ANCEF (cefazolin sodium) Injection, 250 mg/ 

vial, 500 mg/vial, and 5 g/vial 

GlaxoSmithKline, 2301 Renaissance Blvd., 

King of Prussia, PA 19406 

NDA 50–521 CECLOR (cefaclor) Capsules, EQ 250 mg 

and 500 mg base 

Eli Lilly and Co. 

NDA 50–522 CECLOR (cefaclor) Oral Suspension, EQ 125 

mg base/5 mL and EQ 250 mg base/5 mL 

Do. 

NDA 50–527 DURICEF (cefadroxil) Oral Suspension, EQ 

125 mg base/5 mL 

Warner Chilcott, Inc., Rockaway 80 Corporate Center, 100 Enterprise Dr., suite 

280, Rockaway, NJ 07866 

ANDA 61–229 POLYSPORIN (bacitracin zinc; polymyxin B 

sulfate) Ophthalmic Ointment, 500 units/g; 

10,000 units/g 

Monarch Pharmaceuticals, Inc. 

FDA has reviewed its records and, 

under § 314.161, has determined that 

the drug products listed in this 

document were not withdrawn from 

sale for reasons of safety or 

effectiveness. Accordingly, the agency 

will continue to list the drug products 

listed in this document in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’ 

identifies, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. 

Approved ANDAs that refer to the 

NDAs listed in this document are 

unaffected by the discontinued 


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Federal Register / Vol. 73, No. 191 / Wednesday, October 1, 2008 / Notices 57111 

marketing of the products subject to 

those NDAs. Additional ANDAs that 

refer to these products may also be 

approved by the agency if they comply 

with relevant legal and regulatory 

requirements. If FDA determines that 

labeling for these drug products should 

be revised to meet current standards, the 

agency will advise ANDA applicants to 

submit such labeling. 

Dated: September 24, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–23035 Filed 9–30–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0484] 

Preparation for International 

Conference on Harmonization 

Meetings in Brussels, Belgium; Public 

Meeting; Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of meeting; correction. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

correction to the notice of a public 

meeting entitled ‘‘Preparation for 

International Conference on 

Harmonization Meetings in Brussels, 

Belgium; Public Meeting.’’ This meeting 

was announced in the Federal Register 

of September 16, 2008 (73 FR 53428). 

The correction is being made to reflect 

changes in the Summary, Date and 

Time, Location, Contact Person, 

Background, and Agenda portions of the 

document. 

FOR FURTHER INFORMATION CONTACT: 

Tammie Jo Bell, Office of the 

Commissioner, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, by email: 

Tammie.Bell2@fda.hhs.gov or fax: 301– 

827–0003. 

SUPPLEMENTARY INFORMATION: The FDA 

is correcting a notice published in the 

Federal Register of September 16, 2008 

(73 FR 53428), announcing a meeting 

entitled ‘‘Preparation for International 

Conference on Harmonization Meetings 

in Brussels, Belgium.’’ This corrected 

notice is being published in its entirety: 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public meeting entitled ‘‘Preparation for 

International Conference on 

Harmonization Meetings in Brussels, 

Belgium’’ to provide information and 

receive comments on the International 

Conference on Harmonization (ICH) as 

well as the upcoming meetings in 

Brussels, Belgium. The topics to be 

discussed are the topics for discussion 

at the forthcoming ICH Steering 

Committee Meeting. The purpose of the 

meeting is to solicit public input prior 

to the next Steering Committee and 

Expert Working Groups meetings in 

Brussels, Belgium, November 10 to 13, 

2008, at which discussion of the topics 

underway and the future of ICH will 

continue, as well as provide 

comprehensive updates of the various 

ICH topics. 

Date and Time: The meeting will be 

held on Tuesday, October 21, 2008, 

from 2:30 p.m. to 5:30 p.m. 

Location: The meeting will be held at 

5600 Fishers Lane, 3rd floor, Conference 

Rooms D and E, Rockville, MD 20857. 

For security reasons, all attendees are 

asked to arrive no later than 2:15 p.m., 

as you will be escorted from the front 

entrance of 5600 Fishers Lane to 

Conference Rooms D and E. 

Contact Person: All participants must 

register with Tammie Jo Bell, Office of 

the Commissioner, Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, by email: 

Tammie.Bell2@fda.hhs.gov or fax: 301– 

827–0003. 

Registration and Requests for Oral 

Presentations: Send registration 

information (including name, title, firm 

name, address, telephone, and fax 

number), written material, and requests 

to make oral presentation, to the contact 

person by October 14, 2008. 

If you need special accommodations 

due to a disability, please contact 

Tammie Jo Bell at least 7 days in 

advance. 

Transcripts: Transcripts of the 

meeting may be requested in writing 

from the Freedom of Information Office 

(HFI–35), Food and Drug 

Administration, 5600 Fishers Lane, rm. 

12A–66, Rockville, MD 20857, 

approximately 15 working days after the 

meeting at a cost of 10 cents per page. 

Background: The ICH was established 

in 1990 as a joint regulatory/industry 

project to improve, through 

harmonization, the efficiency of the 

process for developing and registering 

new medicinal products in Europe, 

Japan, and the United States without 

compromising the regulatory obligations 

of safety and effectiveness. 

In recent years, many important 

initiatives have been undertaken by 

regulatory authorities and industry 

associations to promote international 

harmonization of regulatory 

requirements. FDA has participated in 

many meetings designed to enhance 

harmonization and is committed to 

seeking scientifically based harmonized 

technical procedures for pharmaceutical 

development. One of the goals of 

harmonization is to identify and then 

reduce differences in technical 

requirements for medical product 

development among regulatory 

agencies. ICH was organized to provide 

an opportunity for harmonization 

initiatives to be developed with input 

from both regulatory and industry 

representatives. ICH is concerned with 

harmonization among three regions: The 

European Union, Japan, and the United 

States. The six ICH sponsors are the 

European Commission; the European 

Federation of Pharmaceutical Industries 

Associations; the Japanese Ministry of 

Health, Labor and Welfare; the Japanese 

Pharmaceutical Manufactures 

Association; the Centers for Drug 

Evaluation and Research and Biologics 

Evaluation and Research, FDA; and the 

Pharmaceutical Research and 

Manufacturers of America. The ICH 

Secretariat, which coordinates the 

preparation of documentation, is 

provided by the International 

Federation of Pharmaceutical 

Manufacturers Associations (IFPMA). 

The ICH Steering Committee includes 

representatives from each of the ICH 

sponsors and Health Canada, the 

European Free Trade Area and the 

World Health Organization. The ICH 

process has achieved significant 

harmonization of the technical 

requirements for the approval of 

pharmaceuticals for human use in the 

three ICH regions. 

The current ICH process and structure 

can be found at the following Web site: 

http://www.ich.org. 

Interested persons may present data, 

information, or views orally or in 

writing, on issues pending at the public 

meeting. Time allotted for oral 

presentations may be limited to 10 

minutes. Those desiring to make oral 

presentations should notify the contact 

person by October 14, 2008, and submit 

a brief statement of the general nature of 

the evidence or arguments they wish to 

present, the names and addresses, 

phone number, fax, and email of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation. 

Agenda: The agenda for the public 

meeting will be made available via the 

internet at http://www.fda.gov/cder/ 

meeting/ICH_20081021.htm. 


jlentini on PROD1PC65 with NOTICES