Federal Register / Vol. 77, No. 53 / Monday, March 19, 2012 / Notices 16039 

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: Circulatory 

System Devices Panel of the Medical 

Devices Advisory Committee. 

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 25 and 26, 2012, from 8 

a.m. to 6 p.m. 

Location: Holiday Inn, Ballroom, 2 

Montgomery Village Ave., Gaithersburg, 

MD 20879. The hotel’s phone number is 

301–948–8900. 

Contact Person: Jamie Waterhouse, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Silver 

Spring, MD 20993, 301–796–3063, 

email: Jamie.Waterhouse@fda.hhs.gov, 

or FDA Advisory Committee 

Information Line, 1–800–741–8138 

(301–443–0572 in the Washington, DC 

area), and follow the prompts to the 

desired center or product area. 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 25, 2012, the committee will 

discuss, make recommendations and 

vote on information related to a 

supplement to the premarket approval 

application (PMA) for the HeartWare 

Ventricular Assist System (HVAS) 

sponsored by HeartWare, Inc. The 

HVAS is an implantable electrically 

powered centrifugal-flow rotary blood 

pump with external driver and power 

source(s). It is the first ventricular assist 

device that does not require the creation 

of an abdominal pump pocket. The 

HVAS is indicated for use as a bridge to 

cardiac transplantation in patients who 

are at risk of death from refractory, 

advanced heart failure. 

On April 26, 2012, the committee will 

discuss, make recommendations and 

vote on information related to the PMA 

for the Subcutaneous Implantable 

Cardioverter Defibrillator (S–ICD) 

System sponsored by Cameron Health, 

Inc. The S–ICD is the first implantable 

defibrillator that does not require the 

implantation of an electrode either on or 

in the heart. The S–ICD is intended to 

provide defibrillation therapy for the 

treatment of life-threatening ventricular 

tachyarrhythmias. The device is capable 

of delivering high energy defibrillation 

shocks as well as bradycardia demand 

mode cardiac pacing. The study 

provides data from the treatment of 

induced acute and chronic episodes of 

ventricular tachycardia/ventricular 

fibrillation and spontaneous episodes. 

In addition to the investigational device 

exemption study, clinical data were also 

obtained from using studies outside the 

United States and registries. 

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 

April 17, 2012. Oral presentations from 

the public will be scheduled between 

approximately 1 p.m. and 2 p.m. on 

April 25 and 26, 2012. Those 

individuals interested in making 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 April 10, 2012. 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 April 12, 2012. 

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 AnnMarie 

Williams, at 

AnnMarie.Williams@fda.hhs.gov, 301– 

796–5966, 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/ 

AdvisoryCommittees/ 

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 13, 2012. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2012–6484 Filed 3–16–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0190] 

Abbott Laboratories et al.; Withdrawal 

of Approval of 35 New Drug 

Applications and 64 Abbreviated New 

Drug Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is withdrawing 

approval of 35 new drug applications 

(NDAs) and 64 abbreviated new drug 

applications (ANDAs) from multiple 

applicants. The holders of the 

applications notified the Agency in 

writing that the drug products were no 

longer marketed and requested that the 

approval of the applications be 

withdrawn. 

DATES: Effective Date: April 18, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Florine P. Purdie, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6366, 

Silver Spring, MD 20993–0002, 301– 

796–3601. 

SUPPLEMENTARY INFORMATION: The 

holders of the applications listed in 

table 1 in this document have informed 


emcdonald on DSK29S0YB1PROD with NOTICES
16040 Federal Register / Vol. 77, No. 53 / Monday, March 19, 2012 / Notices 

FDA that these drug products are no 

longer marketed and have requested that 

FDA withdraw approval of the 

applications under the process in 

§ 314.150(c) (21 CFR 314.150(c)). The 

applicants have also, by their requests, 

waived their opportunity for a hearing. 

Withdrawal of approval of an 

application or abbreviated application 

under § 314.150(c) is without prejudice 

to refiling. 

TABLE 1 

Application No. Drug Applicant 

NDA 005545 ........................ Dicumarol Tablets ........................................................... Abbott Laboratories, PA77/Bldg. AP30–1E, 200 Abbott 

Park Rd., Abbott Park, IL 60064–6157. 

NDA 005845 ........................ Benadryl (diphenhydramine hydrochloride (HCl)), 

Benadryl with Ephedrine Sulfate, and Caladryl 

(diphenhydramine HCl and calamine).

McNeil Consumer Healthcare, Division of McNeil-PPC, 

Inc., 7050 Camp Hill Rd., Fort Washington, PA 

19034–2299. 

NDA 006146 ........................ Benadryl (diphenhydramine HCl)) Injection .................... Do. 

NDA 006773 ........................ Artane (trihexyphenidyl HCl) Tablets and Capsules and 

Artane (trihexyphenidyl) Elixir.

Lederle Laboratories, d/b/a Wyeth Pharmaceuticals, 

P.O. Box 8299, Philadelphia, PA 19101–8299. 

NDA 009486 ........................ Benadryl (diphenhydramine HCl)) Injection Preservative 

Free.

McNeil Consumer Healthcare. 

NDA 010021 ........................ Placidyl (ethchlorvynol) Capsules ................................... Abbott Laboratories, 200 Abbott Park Rd., Abbott Park, 

IL 60064. 

NDA 011552 ........................ Stelazine (trifluoperazine HCl) ........................................ GlaxoSmithKline, P.O. Box 13398, Five Moore Dr., Research Triangle Park, NC 27709–3398. 

NDA 012524 ........................ Enduron (methyclothiazide) Tablets, 2.5 milligrams (mg) 

and 5 mg.

Abbott Laboratories, PA77/Bldg. AP30–1E, 200 Abbott 

Park Rd., Abbott Park, IL 60064–6157. 

NDA 012775 ........................ Enduronyl and Enduronyl Forte (methyclothiazide and 

deserpidine) Tablets.

Do. 

NDA 014684 ........................ Aventyl (nortriptyline HCl) Capsules ............................... Eli Lilly and Co., Lilly Corp. Center, Indianapolis, IN 

46285. 

NDA 017577 ........................ Ditropan (oxybutynin chloride) Tablets ........................... Janssen Pharmaceuticals Inc., c/o Johnson & Johnson 

Pharmaceutical Research and Development, LLC, 

920 Route 202, P.O. Box 300, Raritan, NJ 08869. 

NDA 018473 ........................ Ventolin (albuterol) Inhalation Aerosol1 .......................... GlaxoSmithKline. 

NDA 018557 ........................ Fansidar (sulfadoxine and pyrimethamine) Tablets, 500 

mg and 25 mg.

Hoffman-La Roche, Inc., 340 Kingsland St., Nutley, NJ 

07110–1199. 

NDA 018709 ........................ Capozide (captopril and hydrochlorothiazide) Tablets ... Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 

08543–4000. 

NDA 018814 ........................ Heparin Sodium in 5% Dextrose Injection ...................... Baxter Healthcare Corp., 1620 Waukegan Rd., MPGR– 

AL, McGaw Park, IL 60085. 

NDA 019297 ........................ Novantrone (mitoxantrone HCl) Injection ........................ EMD Serono, One Technology Place, Rockland, MA 

02370. 

NDA 019508 ........................ Axid (nizatidine) Capsules .............................................. SmithKline Beecham Corp., d/b/a GlaxoSmithKline, 

P.O. Box 13398, Five Moore Dr., Research Triangle 

Park, NC 27709–3398. 

NDA 019915 ........................ Monopril (fosinopril sodium) Tablets, 10 mg, 20 mg, 

and 40 mg.

Bristol-Myers Squibb Co. 

NDA 019946 ........................ Nuromax (doxacurium chloride) Injection 1 mg/milliliter 

(mL).

Abbott Laboratories, P76/Bldg. AP30–1E, Abbott Park, 

IL 60064–6157. 

NDA 019960 ........................ Manoplax (flosequinan) Tablets ...................................... Do. 

NDA 020057 ........................ Ceredase (alglucerase) Injection .................................... Genzyme Corp., 500 Kendall St., Cambridge, MA 

02142. 

NDA 020088 ........................ Norplant System (levonorgestrel) Implants ..................... Wyeth Pharmaceuticals, Inc., P.O. Box 8299, Philadelphia, PA 19101–8299. 

NDA 020101 ........................ Prozac (fluoxetine HCl) Oral Solution, 20 mg/5 mL ....... Eli Lilly and Co. 

NDA 020236 ........................ Serevent (salmeterol xinafoate) Inhalation Aerosol1 ...... GlaxoSmithKline. 

NDA 020286 ........................ Monopril-HCT (fosinopril sodium and 

hydrochlorothiazide) Tablets, 20 mg/12.5 mg and 10 

mg/12.5 mg.

Bristol-Myers Squibb Co. 

NDA 020403 ........................ Zofran (ondansetron HCl) Injection ................................. Glaxo Wellcome Manufacturing Pte Limited, d/b/a 

GlaxoSmithKline, 1250 Collegeville Rd., UP4110, 

Collegeville, PA 19426. 

NDA 020627 ........................ Norplant II System (levonorgestrel) Implants ................. Wyeth Pharmaceuticals, Inc. 

NDA 020828 ........................ Fortovase (saquinavir) Capsules, 200 mg ...................... Hoffman-La Roche, Inc. 

NDA 020860 ........................ Levlite (ethinyl estradiol and levonorgestrel) Tablets ..... Bayer HealthCare Pharmaceuticals Inc., P.O. Box 

1000, Montville, NJ 07045. 

NDA 020984 ........................ Raplon (rapacuronium bromide) for Injection ................. Organon USA Inc., 2000 Galloping Hill Rd., Kenilworth, 

NJ 07033. 

NDA 021120 ........................ Novantrone (mitoxantrone HCl) Injection ........................ EMD Serono. 

NDA 021793 ........................ Reglan ODT (metoclopramide) Tablets .......................... Meda Pharmaceuticals Inc., 200 North Cobb Parkway, 

Suite 428, Marietta, GA 30062. 

ANDA 040207 ...................... Prochlorperazine Maleate Tablets USP, 5 mg and 10 

mg.

Duramed Pharmaceuticals, Inc., 400 Chestnut Rd., 

Woodcliff Lake, NJ 07677. 

ANDA 040231 ...................... Chlorpromazine HCl Oral Concentrate USP, 30 mg/mL Pharmaceutical Associates, Inc., 201 Delaware St., 

Greenville, SC 29605. 

NDA 050526 ........................ Staticin (erythromycin) Topical Solution, 1.5% ............... Bristol-Myers Squibb Co. 


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Federal Register / Vol. 77, No. 53 / Monday, March 19, 2012 / Notices 16041 

TABLE 1—Continued 

Application No. Drug Applicant 

NDA 050687 ........................ Banan (cefpodoxime proxetil) Tablets, 100 mg and 200 

mg.

Daiichi Sankyo, Inc., 399 Thornall St., 11th Floor, Edison, NJ 08837. 

NDA 050688 ........................ Banan (cefpodoxime proxetil) Granules for Oral Suspension, 50 mg/5 mL and 100 mg/5 mL.Do. 

ANDA 064098 ...................... Amikacin Sulfate Injection USP, 250 mg (base)/mL ...... Hospira, Inc., 275 North Field Dr., Bldg. H2–2, Lake 

Forest, IL 60045. 

ANDA 064106 ...................... Mitomycin for Injection USP, 20 mg Vial ........................ Do. 

ANDA 070505 ...................... Metoclopramide Injection USP, 5 mg/mL ....................... Do. 

ANDA 070506 ...................... Metoclopramide Injection USP, 5 mg/mL ....................... Do. 

ANDA 070566 ...................... Nitropress (sodium nitroprusside for Injection USP), 50 

mg.

Do. 

ANDA 071015 ...................... Haloperidol Oral Solution USP, 2 mg/mL ....................... Teva Pharmaceuticals USA, 1090 Horsham Rd., P.O. 

Box 1090, North Wales, PA 19454. 

ANDA 071554 ...................... Thiothixene HCl Oral Solution USP, 5 mg/mL ............... Do. 

ANDA 073058 ...................... Fluphenazine HCl Oral Solution USP, 5 mg/mL ............ Do. 

ANDA 073479 ...................... Pentamidine Isethionate for Injection, 300 mg Vial ........ Hospira, Inc. 

ANDA 074636 ...................... Iopamidol Injection USP, 41%, 51%, 61%, 76% ............ Do. 

ANDA 074898 ...................... Iopamidol Injection USP, 41%, 51%, 61%, 76% ............ Do. 

ANDA 075065 ...................... Acyclovir Sodium for Injection ......................................... Do. 

ANDA 075176 ...................... Haloperidol Decanoate Injection, 50 mg/mL and 100 

mg/mL.

Do. 

ANDA 075409 ...................... Midazolam HCl Injection, 1 mg (base)/mL and 5 mg 

(base)/mL.

Do. 

ANDA 075884 ...................... Milrinone Lactate Injection, 1 mg/mL .............................. Do. 

ANDA 076306 ...................... Topiramate Tablets, 25 mg, 50 mg, 100 mg, and 200 

mg.

Roxane Laboratories, Inc., 1809 Wilson Rd., Columbus, 

OH 43228. 

ANDA 077138 ...................... Ciprofloxacin Injection USP in 5% Dextrose Injection .... Teva Pharmaceuticals USA. 

ANDA 077223 ...................... Terbinafine HCl Tablets, 250 mg (base) ........................ Roxane Laboratories, Inc. 

ANDA 077784 ...................... Risperidone Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 

mg, and 4 mg.

Ratiopharm Inc., c/o Columbia Pharma Consulting 

Services Inc., 490 Northwest Datewood Dr., Suite 

400, Issaquah, WA 98027. 

ANDA 078241 ...................... Sumatriptan Succinate Tablets, 25 mg, 50 mg, and 100 

mg (base).

Roxane Laboratories, Inc. 

ANDA 078318 ...................... Sumatriptan Injection, 4 mg (base)/0.5 mL and 6 mg 

(base)/0.5 mL.

TEVA Parenteral Medicines, Inc., 19 Hughes, Irvine, 

CA 92618. 

ANDA 078416 ...................... Prednisolone Sodium Phosphate Oral Solution, 5 mg 

(base)/5 mL.

Vintage Pharmaceuticals, 120 Vintage Dr., Huntsville, 

AL 35811. 

ANDA 078517 ...................... Venlafaxine HCl Tablets, 25 mg (base), 37.5 mg 

(base), 50 mg (base), 75 mg (base), and 100 mg 

(base).

PLIVA Hrvatska d.o.o., c/o Barr Laboratories, Inc., 400 

Chestnut Ridge Rd., Woodcliff Lake, NJ 07677 

ANDA 080997 ...................... Succinylcholine Chloride Injection USP, 20 mg/mL ....... Organon USA Inc. 

ANDA 081125 ...................... Dexamethasone Sodium Phosphate Injection USP, 4 

mg/mL.

TEVA Parenteral Medicines, Inc., 19 Hughes, Irvine, 

CA 92618. 

ANDA 081126 ...................... Dexamethasone Sodium Phosphate Injection USP ....... Do. 

ANDA 081298 ...................... Chlorzoxazone Tablets, 250 mg ..................................... Ranbaxy Inc., U.S. Agent for Ohm, 600 College Rd. 

East, Princeton, NJ 08540. 

ANDA 081299 ...................... Chlorzoxazone Tablets, 500 mg ..................................... Do. 

ANDA 081310 ...................... Fluphenazine HCl Elixir USP, 2.5 mg/5 mL ................... Teva Pharmaceuticals USA. 

ANDA 087005 ...................... Trichlormethiazide Tablets, 4 mg .................................... Par Pharmaceutical, Inc., One Ram Ridge Rd., Spring 

Valley, NY 10977. 

ANDA 087007 ...................... Trichlormethiazide Tablets, 2 mg .................................... Do. 

ANDA 087032 ...................... Chlorpromazine HCl Oral Concentrate USP, 30 mg/mL Morton Grove Pharmaceuticals, Inc., U.S. Agent for 

Wockhardt EU Operations (Swiss) AG, 6451 West 

Main St., Morton Grove, IL 60053. 

ANDA 087053 ...................... Chlorpromazine HCl Oral Concentrate USP, 100 mg/ 

mL.

Do. 

ANDA 087406 ...................... Oxycodone and Acetaminophen Tablets USP, 5 mg/ 

325 mg.

Barr Laboratories, Inc., 400 Chestnut Ridge Rd., 

Woodcliff Lake, NJ 07677. 

ANDA 087585 ...................... Potassium Chloride for Injection Concentrate USP, 2 

mEq/mL.

Luitpold Pharmaceuticals, Inc., One Luitpold Dr., P.O. 

Box 9001, Shirley, NY 11967. 

ANDA 088143 ...................... Trifluoperazine Oral Solution USP, 10 mg/mL ............... Morton Grove Pharmaceuticals, Inc., U.S. Agent for 

Wockhardt EU Operations (Swiss) AG. 

ANDA 088194 ...................... Thioridazine HCl Tablets USP, 50 mg ............................ Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, 400 Chestnut Ridge Rd., Woodcliff 

Lake, NJ 07677. 

ANDA 088227 ...................... Thioridazine HCl Oral Solution USP (Concentrate), 100 

mg/mL.

Morton Grove Pharmaceuticals, Inc., U.S. Agent for 

Wockhardt EU Operations (Swiss) AG. 

ANDA 088258 ...................... Thioridazine HCl Oral Solution USP (Concentrate), 30 

mg/mL.

Do. 

ANDA 088270 ...................... Thioridazine HCl Tablets USP, 10 mg ............................ Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA. 

ANDA 088271 ...................... Thioridazine HCl Tablets USP, 15 mg ............................ Do. 


emcdonald on DSK29S0YB1PROD with NOTICES
16042 Federal Register / Vol. 77, No. 53 / Monday, March 19, 2012 / Notices 

TABLE 1—Continued 

Application No. Drug Applicant 

ANDA 088272 ...................... Thioridazine HCl Tablets USP, 25 mg ............................ Do. 

ANDA 088273 ...................... Thioridazine HCl Tablets USP, 100 mg .......................... Do. 

ANDA 088456 ...................... Thioridazine HCl Tablets USP, 100 mg .......................... Teva Pharmaceuticals USA. 

ANDA 088493 ...................... Thioridazine HCl Tablets USP, 10 mg ............................ Do. 

ANDA 088850 ...................... Hydroflumethiazide Tablets USP, 50 mg ........................ Par Pharmaceutical, Inc. 

ANDA 088907 ...................... Reserpine and Hydroflumethiazide Tablets, 0.125 mg/ 

50 mg.

Do. 

ANDA 088933 ...................... Sulfinpyrazone Tablets, 100 mg ..................................... Do. 

ANDA 088934 ...................... Sulfinpyrazone Capsules USP, 200 mg ......................... Do. 

ANDA 089135 ...................... Methyclothiazide Tablets, 2.5 mg ................................... Do. 

ANDA 089136 ...................... Methyclothiazide Tablets, 5 mg ...................................... Do. 

ANDA 089173 ...................... A–MethaPred (methylprednisolone sodium succinate for 

injection USP), 500 mg (base)/Vial.

Hospira, Inc. 

ANDA 089174 ...................... A–MethaPred (methylprednisolone sodium succinate for 

injection USP), 1 gram (base)/Vial.

Do. 

ANDA 089207 ...................... Methylprednisolone Tablets USP, 16 mg ....................... Par Pharmaceutical, Inc. 

ANDA 089208 ...................... Methylprednisolone Tablets USP, 24 mg ....................... Do. 

ANDA 089209 ...................... Methylprednisolone Tablets USP, 32 mg ....................... Do. 

ANDA 089457 ...................... Perphenazine Tablets USP, 16 mg ................................ Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA. 

ANDA 089602 ...................... Thioridazine HCl Oral Solution USP, 30 mg/mL ............ Teva Pharmaceuticals USA. 

ANDA 089603 ...................... Thioridazine HCl Oral Solution USP, 100 mg/mL .......... Do. 

ANDA 089624 ...................... Reversol (edrophonium chloride injection USP), 10 mg/ 

mL).

Organon USA Inc. 

ANDA 089657 ...................... Methocarbamol and Aspirin Tablets, 400 mg/325 mg .... Par Pharmaceutical, Inc. 

ANDA 089708 ...................... Perphenazine Tablets USP, 4 mg .................................. Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA. 

1This product included an oral pressurized metered-dose inhaler that contained chlorofluorocarbons (CFCs) as a propellant. CFCs may no 

longer be used as a propellant for any albuterol or salmeterol metered-dose inhalers (see 70 FR 17168, April 4, 2005; 71 FR 70870, December 

7, 2006). 

Therefore, under section 505(e) of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 355(e)) and under 

authority delegated to the Director, 

Center for Drug Evaluation and 

Research, by the Commissioner, 

approval of the applications listed in 

table 1 in this document, and all 

amendments and supplements thereto, 

is hereby withdrawn, effective April 18, 

2012. Introduction or delivery for 

introduction into interstate commerce of 

products without approved new drug 

applications violates section 301(a) and 

(d) of the FD&C Act (21 U.S.C. 331(a) 

and (d)). Drug products that are listed in 

table 1 in this document that are in 

inventory on the date that this notice 

becomes effective (see the DATES

section) may continue to be dispensed 

until the inventories have been depleted 

or the drug products have reached their 

expiration dates or otherwise become 

violative, whichever occurs first. 

Dated: February 16, 2012. 

Janet Woodcock, 

Director, Center for Drug Evaluation and 

Research. 

[FR Doc. 2012–6591 Filed 3–16–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: 

Comment Request 

In compliance with the requirement 

for opportunity for public comment on 

proposed data collection projects 

(section 3506(c)(2)(A) of Title 44, United 

States Code, as amended by the 

Paperwork Reduction Act of 1995, Pub. 

L. 104–13), the Health Resources and 

Services Administration (HRSA) 

publishes periodic summaries of 

proposed projects being developed for 

submission to the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and draft instruments, email 

paperwork@hrsa.gov or call the HRSA 

Reports Clearance Officer at (301) 443– 

1984. 

Comments are invited on: (a) The 

proposed collection of information for 

the proper performance of the functions 

of the agency; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. 

Proposed Project: Enrollment and ReCertification of Entities in the 340B 

Drug Pricing Program (OMB No. 0915– 

0327)—Revision 

Section 602 of Public Law 102–585, 

the Veterans Health Care Act of 1992, 

enacted section 340B of the Public 

Health Service Act (PHS Act) 

‘‘Limitation on Prices of Drugs 

Purchased by Covered Entities.’’ Section 

340B provides that a manufacturer who 

sells covered outpatient drugs to eligible 

entities must sign a pharmaceutical 

pricing agreement with the Secretary of 

Health and Human Services in which 

the manufacturer agrees to charge a 

price for covered outpatient drugs that 

will not exceed an amount determined 

under a statutory formula. 

Covered entities which choose to 

participate in the section 340B Drug 

Pricing Program must comply with the 

requirements of section 340B(a)(5) of the 

PHS Act. Section 340B(a)(5)(A) 

prohibits a covered entity from 

accepting a discount for a drug that 

would also generate a Medicaid rebate. 


emcdonald on DSK29S0YB1PROD with NOTICES