82 FR 46079 - Johnson & Johnson Consumer Inc. et al.; Withdrawal of Approval of 7 New Drug Applications and 71 Abbreviated New Drug Applications
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 190 (October 3, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 190 (October 3, 2017)
| Page Range | 46079-46081 | |
| FR Document | 2017-21177 |
[Federal Register Volume 82, Number 190 (Tuesday, October 3, 2017)] [Notices] [Pages 46079-46081] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-21177] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-4563] Johnson & Johnson Consumer Inc. et al.; Withdrawal of Approval of 7 New Drug Applications and 71 Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of 7 new drug applications (NDAs) and 71 abbreviated new drug applications (ANDAs) from multiple [[Page 46080]] 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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: Withdrawal of approval is effective November 2, 2017. FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301- 796-3601. SUPPLEMENTARY INFORMATION: The holders of the applications listed in the table have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications pursuant to the process in Sec. 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 Sec. 314.150(c) is without prejudice to refiling. ---------------------------------------------------------------------------------------------------------------- Application No. Drug Applicant ---------------------------------------------------------------------------------------------------------------- NDA 014349.............................. Delfen (nonoxynol-9) Johnson & Johnson Consumer Inc., 199 Contraceptive Foam, 12.5%. Grandview Rd., Skillman, NJ 08558. ANDA 019346............................. Dextrose 60% Injection USP in Hospira, Inc., 275 North Field Dr., Plastic Container. Dept. 389, Bldg. H2-2, Lake Forest, IL 60045. NDA 019810.............................. Prilosec (omeprazole) Delayed- AstraZeneca Pharmaceuticals LP, One Release Capsules, 10 milligrams MedImmune Way, Gaithersburg, MD (mg), 20 mg, and 40 mg. 20878. NDA 020184.............................. Aceon (perindopril erbumine) Symplmed Pharmaceuticals, LLC, 5375 Tablets, 2 mg, 4 mg, and 8 mg. Medspace Way, Cincinnati, OH 45227. NDA 022345.............................. Potiga (ezogabine) Tablets, 50 GlaxoSmithKline Intellectual mg, 200 mg, 300 mg, and 400 mg. Property Management LTD England, c/ o GlaxoSmithKline, 1250 South Collegeville Road, P.O. Box 5089, Collegeville, PA 19426. NDA 021712.............................. Fluxid (famotidine) Orally UCB, Inc., 1950 Lake Park Dr., Bldg. Disintegrating Tablets, 20 mg 2100, Smyrna, GA 30080. and 40 mg. ANDA 040108............................. Acetazolamide for Injection USP, Hospira, Inc. Equivalent to (EQ) 500 mg base/ vial. ANDA 040206............................. Digoxin Injection USP, 0.25 mg/ Do. milliliter (mL). ANDA 040527............................. Phentermine Hydrochloride (HCl) Sun Pharmaceutical Industries, Inc., Capsules USP, 37.5 mg. 270 Prospect Plains Rd., Cranbury, NJ 08512. ANDA 040899............................. Hydroxyzine HCl Tablets USP, 10 Do. mg, 25 mg, and 50 mg. ANDA 060099............................. Penicillin G Procaine for Pfizer Inc., 235 East 42nd St., New Injection, 300,000 units/vial York, NY 10017. and 1,500,000 units/vial. ANDA 063161............................. Tobramycin Injection USP, EQ 40 Hospira, Inc. mg base/mL. ANDA 070171............................. Naloxone HCl Injection USP, 0.02 Do. mg/mL. ANDA 070186............................. Disopyramide Phosphate Capsules Ivax Pharmaceuticals, Inc., USP, EQ 100 mg base. Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. ANDA 070233............................. Propranolol HCl Tablets USP, 20 Teva Pharmaceuticals USA, Inc., 425 mg. Privet Rd., Horsham, PA 19044. ANDA 070255............................. Naloxone HCl Injection, 0.4 mg/ Hospira, Inc. mL. ANDA 070698............................. Methyldopate HCl Injection USP, Do. 50 mg/mL, ADD-Vantage Vial. ANDA 070699............................. Methyldopate HCl Injection USP, Do. 50 mg/mL, Fliptop Vial. ANDA 070739............................. Verapamil HCl Injection, 2.5 mg/ Do. mL, 2 mL Abbojet-PA Syringe. ANDA 070740............................. Verapamil HCl Injection, 2.5 mg/ Do. mL, 4 mL Abbojet Syringe Vial. ANDA 070803............................. Enflurane USP, 99.9%............ Abbott Laboratories, Hospital Products Division, 200 Abbott Park Rd., D389, Bldg. J45-2, Abbott Park, IL 60064. ANDA 070888............................. Aminocaproic Acid Injection USP, Hospira, Inc. 250 mg/mL. ANDA 071357............................. Tolazamide Tablets USP, 100 mg.. Sun Pharmaceutical Industries, Inc. ANDA 071438............................. Ritodrine HCl in Dextrose 5% Hospira, Inc. Injection, 30 mg/100 mL. ANDA 071618............................. Ritodrine HCl Injection USP, 10 Do. mg/mL. ANDA 071619............................. Ritodrine HCl Injection USP, 15 Do. mg/mL. ANDA 071982............................. Droperidol and Fentanyl Citrate Do. Injection, 2.5 mg/mL and EQ 0.05 mg base/mL. ANDA 072321............................. Pancuronium Bromide Injection, 2 Do. mg/mL. ANDA 073199............................. Sulfamethoxazole and Do. Trimethoprim Injection USP, 80 mg/mL and 16 mg/mL. ANDA 073310............................. Tolmetin Sodium Tablets USP, EQ Sun Pharmaceutical Industries, Inc. 200 mg base. ANDA 073428............................. CO-LAV (polyethylene glycol 3350 Vintage Pharmaceuticals, 150 Vintage and electrolytes) for Oral Dr., Huntsville, AL 35811. Suspension. ANDA 073433............................. GO-EVAC (polyethylene glycol Do. 3350 and electrolytes) for Oral Suspension. ANDA 073677............................. Carbastat (carbachol) Novartis Pharmaceuticals Corp., One Intraocular Solution, 0.01%. Health Plaza, East Hanover, NJ 07936. ANDA 074168............................. Diltiazem HCl Tablets USP, 30 Ivax Pharmaceuticals, Inc., mg, 60 mg, 90 mg, and 120 mg. Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 074280............................. Lorazepam Injection USP, 2 mg/mL Hospira, Inc. and 4 mg/mL. ANDA 074296............................. Cimetidine HCl Injection, EQ 300 Do. mg base/2 mL (Carpuject). ANDA 074412............................. Cimetidine HCl Injection, EQ 300 Do. mg base/2 mL. ANDA 074422............................. Cimetidine HCl Injection, EQ 300 Do. mg base/2 mL, ADD-Vantage Vial. ANDA 074468............................. Cimetidine HCl in Sodium Do. Chloride 0.9% Injection in Plastic Container, EQ 90 mg base/100 mL, EQ 120 mg base/100 mL, EQ 180 mg base/100 mL, EQ 240 mg base/100 mL, EQ 360 mg/ 100 mL, and EQ 480 mg base/100 mL. ANDA 074620............................. Butorphanol Tartrate Injection Do. USP, 1 mg/mL and 2 mg/mL. ANDA 074758............................. Acyclovir for Injection USP, EQ Do. 500 mg base/vial and EQ 1 gram (g) base/vial. [[Page 46081]] ANDA 074801............................. Ketorolac Tromethamine Injection Do. USP, 15 mg/mL and 30 mg/mL. ANDA 075385............................. Buspirone HCl Tablets USP, 5 mg, Ivax Pharmaceuticals, Inc., 10 mg, and 15 mg. Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 075453............................. Doxazosin Tablets USP, EQ 1 mg Do. base, EQ 2 mg base, EQ 4 mg base, and EQ 8 mg base. ANDA 076883............................. Sotalol HCl Tablets USP, 80 mg, Teva Pharmaceuticals USA, Inc. 120 mg, and 160 mg. ANDA 077052............................. Citalopram Hydrobromide Tablets, Sun Pharmaceutical Industries, Inc. EQ 10 mg base, EQ 20 mg base, and EQ 40 mg base. ANDA 077937............................. Meloxicam Tablets, 7.5 mg and 15 Do. mg. ANDA 078081............................. Amlodipine Besylate Tablets, EQ Do. 2.5 mg base, EQ 5 mg base, and EQ 10 mg base. ANDA 078158............................. Fosphenytoin Sodium Injection Hospira, Inc. USP, EQ 50 mg Phenytoin Soudium/ mL. ANDA 078483............................. Zolpidem Tartrate Extended- Synthon Pharmaceuticals, Inc., 1007 Release Tablets USP, 6.25 mg Slater Rd., Suite 150, Durham, NC and 12.5 mg. 27703. ANDA 080136............................. Isoniazid Tablets, 100 mg....... Sun Pharmaceutical Industries, Inc. ANDA 080209............................. Prednisone Tablets USP, 5 mg.... Contract Pharmacal Corp., c/o SciRegs International Inc., 6333 Summercrest Dr., Columbia, MD 21045. ANDA 080224............................. Sorbitol; Mannitol Irrigation Hospira, Inc. Solution, 2.7 g/100 mL; 540 mg/ 100 mL. ANDA 083345............................. Potassium Chloride for Injection Do. Concentrate USP, 1 milliequivalent (mEQ)/mL, 1.5 mEQ/mL, and 2 mEQ/mL. ANDA 083808............................. Quinidine Sulfate Tablets USP, Contract Pharmacal Corp., c/o 200 mg. SciRegs International Inc. ANDA 084623............................. Chlordiazepoxide HCl Capsules Upsher-Smith Laboratories, Inc., USP, 10 mg. 6701 Evenstad Dr., Maple Grove, MN 55369. ANDA 084644............................. Chlordiazepoxide HCl Capsules Do. USP, 5 mg. ANDA 084710............................. Ogen (estropipate) Vaginal Cream Pfizer Inc. USP, 1.5 mg/g. ANDA 085061............................. Folic Acid Tablets USP, 1 mg.... Contract Pharmacal Corp., c/o SciRegs International Inc. ANDA 085933............................. Phentermine HCl Tablets USP..... Lemmon Co., 650 Cathill Rd., Sellersville, PA 18960. ANDA 086494............................. Chlordiazepoxide HCl Capsules, Teva Pharmaceuticals USA, Inc. 25 mg. ANDA 086821............................. Hydroxyzine HCl Injection USP, Hospira, Inc. 50 mg/mL. ANDA 087416............................. Hydroxyzine HCl Injection USP, Do. 25 mg/mL, Carpuject. ANDA 087546............................. Hydroxyzine HCl Injection USP, Do. 50 mg/mL, Carpuject. ANDA 087862............................. Hydroxyzine HCl Tablets USP, 100 Sun Pharmaceutical Industries, Inc. mg. ANDA 088147............................. Aminophylline in Sodium Chloride Hospira, Inc. 0.45% Injection, 100 mg/100 mL and 200 mg/100 mL. ANDA 088367............................. Lidocaine HCl Injection USP, 10% Do. ANDA 088542............................. Lidocaine HCl Injection USP, 4%. Do. ANDA 089162............................. Cyclopentolate HCl Ophthalmic Alcon Pharmaceuticals, Ltd., 6201 Solution, 1%. South Freeway TC-45, Fort Worth, TX 76134. ANDA 089347............................. Diatrizoate Meglumine and Bracco Diagnostics Inc., 259 Diatrizoate Sodium Injection Prospect Plains Rd., Bldg. H, USP, 66%; 10%. Monroe Township, NJ 08831. ANDA 089393............................. Glycopyrrolate Injection USP, Hospira, Inc. 0.2 mg/mL. ANDA 089488............................. Diphenhydramine HCl Capsules, 25 Sun Pharmaceutical Industries, Inc. mg. ANDA 089521............................. Phenytoin Sodium Injection USP, Hospira, Inc. 50 mg/mL, Ampule. ANDA 089537............................. Procainamide HCl Injection USP, Do. 500 mg/mL, Carpuject. ANDA 089744............................. Phenytoin Sodium Injection USP, Do. 50 mg/mL, Carpuject. ANDA 089915............................. Leucovorin Calcium for Pharmachemie B.V., c/o SICOR Injection, EQ 100 mg base/vial. Pharmaceuticals, Inc., 19 Hughes, Irvine, CA 92618. NDA 202258.............................. Victrelis (boceprevir) Capsules, Merck Sharp & Dohme Corp., 200 mg. Subsidiary of Merck & Company, Inc., 1 Merck Dr., P.O. Box 100, Whitehouse Station, NJ 08889. NDA 203093.............................. Vitekta (elvitegravir) Tablets, Gilead Sciences, Inc., 333 Lakeside 85 mg and 150 mg. Dr., Foster City, CA 94404. ---------------------------------------------------------------------------------------------------------------- Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn, effective November 2, 2017. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in the table that are in inventory on the date that this notice becomes effective (see DATES) 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: September 27, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-21177 Filed 10-2-17; 8:45 am] BILLING CODE 4164-01-P
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members and observers.
Administration, 10903 New Hampshire Food and Drug Administration
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on the organization of the CTD and [Docket No. FDA–2017–N–4563]
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fda.hhs.gov; or Stephen Ripley, Center Johnson & Johnson Consumer Inc. et
providing direction on the location and
for Biologics Evaluation and Research, al.; Withdrawal of Approval of 7 New
hierarchy of headings within modules,
Food and Drug Administration, 10903 Drug Applications and 71 Abbreviated
document pagination and segregation,
New Hampshire Ave., Bldg. 71, Rm. New Drug Applications
section numbering within documents,
7301, Silver Spring, MD 20993–0002,
asabaliauskas on DSKBBXCHB2PROD with NOTICES
and the formatting of the table of AGENCY: Food and Drug Administration,
240–402–7911. Regarding the ICH:
contents. The guidance updates the HHS.
Amanda Roache, Center for Drug
Quality-related sections of the ACTION: Notice.
Evaluation and Research, Food and
Granularity Document Annex, Module
Drug Administration, 10903 New
2.3 Quality Overall Summary, and SUMMARY: The Food and Drug
Hampshire Ave., Bldg. 51, Rm. 1176,
Module 3 Quality. The guidance Administration (FDA) is withdrawing
Silver Spring, MD 20993–0002, 301–
provides separate tables describing the approval of 7 new drug applications
796–4548.
recommended granularity for paper and (NDAs) and 71 abbreviated new drug
SUPPLEMENTARY INFORMATION: eCTD v3.2.2 submissions, and for paper applications (ANDAs) from multiple
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![Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices 46081
Application No. Drug Applicant
ANDA 074801 ......................... Ketorolac Tromethamine Injection USP, 15 mg/mL and 30 Do.
mg/mL.
ANDA 075385 ......................... Buspirone HCl Tablets USP, 5 mg, 10 mg, and 15 mg ..... Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA,
Inc.
ANDA 075453 ......................... Doxazosin Tablets USP, EQ 1 mg base, EQ 2 mg base, Do.
EQ 4 mg base, and EQ 8 mg base.
ANDA 076883 ......................... Sotalol HCl Tablets USP, 80 mg, 120 mg, and 160 mg .... Teva Pharmaceuticals USA, Inc.
ANDA 077052 ......................... Citalopram Hydrobromide Tablets, EQ 10 mg base, EQ Sun Pharmaceutical Industries, Inc.
20 mg base, and EQ 40 mg base.
ANDA 077937 ......................... Meloxicam Tablets, 7.5 mg and 15 mg .............................. Do.
ANDA 078081 ......................... Amlodipine Besylate Tablets, EQ 2.5 mg base, EQ 5 mg Do.
base, and EQ 10 mg base.
ANDA 078158 ......................... Fosphenytoin Sodium Injection USP, EQ 50 mg Phe- Hospira, Inc.
nytoin Soudium/mL.
ANDA 078483 ......................... Zolpidem Tartrate Extended-Release Tablets USP, 6.25 Synthon Pharmaceuticals, Inc., 1007 Slater Rd., Suite 150, Durham, NC
mg and 12.5 mg. 27703.
ANDA 080136 ......................... Isoniazid Tablets, 100 mg ................................................... Sun Pharmaceutical Industries, Inc.
ANDA 080209 ......................... Prednisone Tablets USP, 5 mg .......................................... Contract Pharmacal Corp., c/o SciRegs International Inc., 6333
Summercrest Dr., Columbia, MD 21045.
ANDA 080224 ......................... Sorbitol; Mannitol Irrigation Solution, 2.7 g/100 mL; 540 Hospira, Inc.
mg/100 mL.
ANDA 083345 ......................... Potassium Chloride for Injection Concentrate USP, 1 Do.
milliequivalent (mEQ)/mL, 1.5 mEQ/mL, and 2 mEQ/mL.
ANDA 083808 ......................... Quinidine Sulfate Tablets USP, 200 mg ............................. Contract Pharmacal Corp., c/o SciRegs International Inc.
ANDA 084623 ......................... Chlordiazepoxide HCl Capsules USP, 10 mg .................... Upsher-Smith Laboratories, Inc., 6701 Evenstad Dr., Maple Grove, MN
55369.
ANDA 084644 ......................... Chlordiazepoxide HCl Capsules USP, 5 mg ...................... Do.
ANDA 084710 ......................... Ogen (estropipate) Vaginal Cream USP, 1.5 mg/g ............ Pfizer Inc.
ANDA 085061 ......................... Folic Acid Tablets USP, 1 mg ............................................ Contract Pharmacal Corp., c/o SciRegs International Inc.
ANDA 085933 ......................... Phentermine HCl Tablets USP ........................................... Lemmon Co., 650 Cathill Rd., Sellersville, PA 18960.
ANDA 086494 ......................... Chlordiazepoxide HCl Capsules, 25 mg ............................. Teva Pharmaceuticals USA, Inc.
ANDA 086821 ......................... Hydroxyzine HCl Injection USP, 50 mg/mL ........................ Hospira, Inc.
ANDA 087416 ......................... Hydroxyzine HCl Injection USP, 25 mg/mL, Carpuject ...... Do.
ANDA 087546 ......................... Hydroxyzine HCl Injection USP, 50 mg/mL, Carpuject ...... Do.
ANDA 087862 ......................... Hydroxyzine HCl Tablets USP, 100 mg ............................. Sun Pharmaceutical Industries, Inc.
ANDA 088147 ......................... Aminophylline in Sodium Chloride 0.45% Injection, 100 Hospira, Inc.
mg/100 mL and 200 mg/100 mL.
ANDA 088367 ......................... Lidocaine HCl Injection USP, 10% ..................................... Do.
ANDA 088542 ......................... Lidocaine HCl Injection USP, 4% ....................................... Do.
ANDA 089162 ......................... Cyclopentolate HCl Ophthalmic Solution, 1% .................... Alcon Pharmaceuticals, Ltd., 6201 South Freeway TC–45, Fort Worth,
TX 76134.
ANDA 089347 ......................... Diatrizoate Meglumine and Diatrizoate Sodium Injection Bracco Diagnostics Inc., 259 Prospect Plains Rd., Bldg. H, Monroe
USP, 66%; 10%. Township, NJ 08831.
ANDA 089393 ......................... Glycopyrrolate Injection USP, 0.2 mg/mL .......................... Hospira, Inc.
ANDA 089488 ......................... Diphenhydramine HCl Capsules, 25 mg ............................ Sun Pharmaceutical Industries, Inc.
ANDA 089521 ......................... Phenytoin Sodium Injection USP, 50 mg/mL, Ampule ....... Hospira, Inc.
ANDA 089537 ......................... Procainamide HCl Injection USP, 500 mg/mL, Carpuject .. Do.
ANDA 089744 ......................... Phenytoin Sodium Injection USP, 50 mg/mL, Carpuject .... Do.
ANDA 089915 ......................... Leucovorin Calcium for Injection, EQ 100 mg base/vial .... Pharmachemie B.V., c/o SICOR Pharmaceuticals, Inc., 19 Hughes,
Irvine, CA 92618.
NDA 202258 ........................... Victrelis (boceprevir) Capsules, 200 mg ............................. Merck Sharp & Dohme Corp., Subsidiary of Merck & Company, Inc., 1
Merck Dr., P.O. Box 100, Whitehouse Station, NJ 08889.
NDA 203093 ........................... Vitekta (elvitegravir) Tablets, 85 mg and 150 mg .............. Gilead Sciences, Inc., 333 Lakeside Dr., Foster City, CA 94404.
Therefore, approval of the Dated: September 27, 2017. DEPARTMENT OF HEALTH AND
applications listed in the table, and all Anna K. Abram, HUMAN SERVICES
amendments and supplements thereto, Deputy Commissioner for Policy, Planning,
is hereby withdrawn, effective Legislation, and Analysis. Food and Drug Administration
November 2, 2017. Introduction or [FR Doc. 2017–21177 Filed 10–2–17; 8:45 am] [Docket No. FDA–2017–N–4977]
delivery for introduction into interstate BILLING CODE 4164–01–P
commerce of products without Joint Meeting of the
approved new drug applications Psychopharmacologic Drugs Advisory
violates section 301(a) and (d) of the Committee and the Drug Safety and
Federal Food, Drug, and Cosmetic Act Risk Management Advisory
(21 U.S.C. 331(a) and (d)). Drug Committee; Notice of Meeting;
products that are listed in the table that Establishment of a Public Docket;
are in inventory on the date that this Request for Comments
asabaliauskas on DSKBBXCHB2PROD with NOTICES
notice becomes effective (see DATES) AGENCY: Food and Drug Administration,
may continue to be dispensed until the HHS.
inventories have been depleted or the ACTION: Notice; establishment of a
drug products have reached their public docket; request for comments.
expiration dates or otherwise become
violative, whichever occurs first. SUMMARY: The Food and Drug
Administration (FDA or Agency)
announces a forthcoming public
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Document Created: 2017-10-03 01:01:14
Document Modified: 2017-10-03 01:01:14
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Withdrawal of approval is effective November 2, 2017. | |
| Contact | Florine P. Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301- 796-3601. | |
| FR Citation | 82 FR 46079 |
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