Federal Register / Vol. 75, No. 47 / Thursday, March 11, 2010 / Notices 11549 

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1—Continued 

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

1271.160(b)(3) and (b)(6) 1,694 12 20,328 1 20,328 

1271.160(d) 1,694 12 20,328 1 20,328 

1271.190(d)(2) 1,694 12 20,328 1 20,328 

1271.195(d) 1,694 12 20,328 1 20,328 

1271.200(e) 1,694 12 20,328 1 20,328 

1271.210(d) 1,694 12 20,328 1 20,328 

1271.230(a) 1,694 12 20,328 1 20,328 

1271.230(c) 1,694 1 1,694 1 1,694 

1271.260(d) 1,694 12 20,328 .25 5,082 

1271.260(e) 1,694 365 618,310 .083 51,526 

1271.265(c)(1) 1,694 1,196 2,026,024 .083 168,835 

1271.265(c)(3) 847 1 847 1 847 

1271.265(e) 1,694 1,196 2,026,024 .083 168,835 

1271.270(a) 1,694 1,196 2,026,024 .25 506,506 

1271.270(e) 1,824 2 3,648 .5 1,824 

1271.290(d) and (e) 1,694 51 86,394 .25 21,599 

1271.320(b) 1,141 5 5,705 1 5,705 

Total 1,967,496 

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

2Sections 1271.47(a), 1271.85(b)(2), 1271.160(b)(2) and (d)(1), 1271.180(a), 1271.190(d)(1), 1271.200(b), 1271.200(c), 1271.230(a), 

1271.250(a), and 1271.265(e). 

Dated: March 8, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–5229 Filed 3–10–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0109] 

Determination That PRO–BANTHINE 

(Propantheline Bromide) Tablets and 

14 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Withdrawn From Sale for Reasons of 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 15 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document were not withdrawn from 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 

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). 


jlentini on DSKJ8SOYB1PROD with NOTICES
11550 Federal Register / Vol. 75, No. 47 / Thursday, March 11, 2010 / Notices 

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 12–097 for 

KENALOG IN ORABASE (triamcinolone 

acetonide) Dental Paste in the Federal 

Register of February 11, 2009 (74 FR 

6896).) 

Application No. Drug Applicant 

NDA 8–732 PRO–BANTHINE (propantheline bromide) 

Tablets, 7.5 milligrams (mg) and 15 mg 

Shire Pharmaceuticals, Inc.,725 Chesterbrook 

Blvd., Wayne, PA 19087) 

NDA 12–097 KENALOG IN ORABASE (triamcinolone 

acetonide) Dental Paste, 0.1% 

Apothecon, Inc., c/o Bristol-Myers Squibb, 

P.O. Box 4500, Princeton, NJ 08543–4500 

NDA 12–141 CYTOXAN (cyclophosphamide) Tablets, 25 

mg and 50 mg 

Baxter Healthcare Corp., 1620 Waukegan Rd. 

MPGR–AL, McGaw Park, IL 60085 

NDA 17–498 MICRONASE (glyburide) Tablets, 1.25 mg, 

2.5 mg, and 5 mg 

Pharmacia and Upjohn Co., 7171 Portage 

Rd., Kalamazoo, MI 49001 

NDA 17–924 TAGAMET (cimetidine HCl) Oral Solution, 

Equivalent to (EQ) 300 mg base/5 mL 

GlaxoSmithKline, 5 Moore Dr., P.O. Box 

13398, Research Triangle Park, NC 27709– 

3398 

NDA 18–207 DESYREL (trazodone HCl) Tablets, 50 mg, 

100 mg, 150 mg, and 300 mg 

Apothecon, Inc. 

NDA 19–425 TRANDATE (labetalol HCl) Injection, 5 mg/mL Prometheus Laboratories, Inc., 9410 Carroll 

Park Dr., San Diego, CA 92121 

NDA 20–101 PROZAC (fluoxetine HCl) Oral Solution, EQ 

20 mg base/5 mL 

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

NDA 20–286 MONOPRIL–HCT (fosinopril sodium; 

hydrochlorothiazide) Tablets, 10 mg/12.5 

mg, 20 mg/12.5 mg 

Bristol-Myers Squibb Co., P.O. Box 4000, 

Princeton, NJ 08543–4000 

NDA 20–664 DOSTINEX (cabergoline) Tablet, 0.5 mg Pharmacia and Upjohn Co. 

NDA 20–683 ALESSE (ethinyl estradiol; levonorgestrel) 

Tablets (21 Tablets and 28 Tablets), 0.02 

mg; 0.1 mg 

Wyeth Pharmaceuticals Inc., P.O. Box 8299, 

Philadelphia, PA 19101–8299 

NDA 20–801 PEPCID AC (famotidine) Chewable Tablet, 10 

mg 

Merck Research Laboratories, Sumneytown 

Pike BLA 20, P.O. Box 4, West Point, PA 

19486–0004 

NDA 20–860 LEVLITE (ethinyl estradiol; levonorgestrel) 

Tablets (21 Tablets and 28 Tablets), 0.02 

mg; 0.1 mg 

Bayer Healthcare Pharmaceuticals, Inc., 340 

Changebridge Rd., P.O. Box 1000, 

Montville, NJ 07045–1000 

NDA 21–455 BONIVA (ibandronate sodium) Tablet, EQ 2.5 

mg base 

Hoffmann LaRoche, Inc., 340 Kingsland St., 

Bldg. 719/4, Nutley, NJ 07110–1199 

NDA 50–517 MEFOXIN (cefoxitin sodium) Injection, EQ 1 

gram (g) base/vial and EQ 2 g base/vial 

Merck and Co., Inc., Sumneytown Pike BLA 

20, P.O. Box 4, West Point, PA 19486– 

0004 

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 

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. 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 47 / Thursday, March 11, 2010 / Notices 11551 

Dated: March 8, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–5275 Filed 3–10–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

Advisory Committee for 

Pharmaceutical Science and Clinical 

Pharmacology; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Advisory 

Committee for Pharmaceutical Science 

and Clinical Pharmacology. 

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on April 14, 2010, from 8 a.m. to 

5 p.m. 

Location: Hilton Washington DC/ 

Silver Spring, The Ballrooms, 8727 

Colesville Rd., Silver Spring, MD. The 

hotel phone number is 301–589–5200. 

Contact Person: Anuja Patel, Center 

for Drug Evaluation and Research (HFD– 

21), Food and Drug Administration, 

5600 Fishers Lane (for express delivery, 

5630 Fishers Lane, rm. 1093) Rockville, 

MD 20857, 301–827–7001, FAX: 301– 

827–6776, e-mail: 

Anuja.Patel@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512539. Please call the Information 

Line for up-to-date information on this 

meeting. A notice in the Federal 

Register about last minute modifications 

that impact a previously announced 

advisory committee meeting cannot 

always be published quickly enough to 

provide timely notice. Therefore, you 

should always check the agency’s Web 

site and call the appropriate advisory 

committee hot line/phone line to learn 

about possible modifications before 

coming to the meeting. 

Agenda: On April 14, 2010, the 

committee will: (1) Receive 

presentations from the Office of Generic 

Drugs (OGD) on a proposal for revision 

of the bioequivalence (BE) approaches, 

specifically to discuss the addition of a 

limitation on point estimates; (2) receive 

presentations on an awareness topic to 

highlight some issues associated with 

product instability (failure of a marketed 

product to meet stability specifications 

through the expiration date), and the 

potential research needs to address 

those issues; and (3) receive and discuss 

presentations from Office of 

Pharmaceutical Science (OPS) on the 

regulatory challenges of drug-induced 

phospholipidosis (excessive 

intracellular accumulation of 

phospholipids, a kind of fatty molecule, 

due to the use of certain drugs). 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/ 

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before March 30, 2010. 

Oral presentations from the public will 

be scheduled between approximately 1 

p.m. and 2 p.m. Those desiring to make 

formal oral presentations should notify 

the contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before March 22, 2010. Time allotted 

for each presentation may be limited. If 

the number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by March 23, 2010. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Anuja Patel 

at least 7 days in advance of the 

meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: March 8, 2010. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2010–5264 Filed 3–10–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Eye Institute; Notice of 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of a meeting of the 

National Advisory Eye Council. 

The meeting will be open to the 

public as indicated below, with 

attendance limited to space available. 

Individuals who plan to attend and 

need special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications 

and/or contract proposals and the 

discussions could disclose confidential 

trade secrets or commercial property 

such as patentable material, and 

personal information concerning 

individuals associated with the grant 

applications and/or contract proposals, 

the disclosure of which would 

constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Advisory 

Eye Council. 

Date: June 17, 2010. 

Closed: 8:30 a.m. to 11 a.m. 

Agenda: To review and evaluate grant 

applications and/or proposals. 

Place: Melrose Hotel, 2430 Pennsylvania 

Ave., NW., Washington, DC 20037. 

Open: 11 a.m. to 5 p.m. 

Agenda: Following opening remarks by the 

Director, NEI, there will be presentations by 


jlentini on DSKJ8SOYB1PROD with NOTICES