[Federal Register Volume 62, Number 81 (Monday, April 28, 1997)]
[Notices]
[Pages 22960-22962]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-10911]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N-0138]


Environmental Assessments and Findings of No Significant Impact

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that it 
has reviewed environmental assessments (EA's) and issued findings of no 
significant impact (FONSI's) relating to the 141 new drug applications 
(NDA's), abbreviated new drug applications (ANDA's), and supplemental 
applications listed in this document. FDA is publishing this notice 
because Federal regulations require public notice of the availability 
of environmental documents.

ADDRESSES: The EA's and FONSI's may be seen in the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 
1-23, Rockville, MD 20857, or a copy may be requested by writing the 
Freedom of Information Staff (HFI-35), Food and Drug Administration, 
5600 Fishers Lane, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Nancy B. Sager, Center for Drug 
Evaluation and Research (HFD-357), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-5721.

SUPPLEMENTARY INFORMATION: Under the National Environmental Policy Act 
of 1969 (NEPA), Congress declared that it will be the continuing policy 
of the Federal Government to ``use all practicable means and measures, 
including financial and technical assistance, in a manner calculated to 
foster and promote the general welfare, to create and maintain 
conditions under which man and nature can exist in productive harmony, 
and fulfill the social, economic and other requirements of present and 
future generations of Americans.'' (See 42 U.S.C. 4331(a).) NEPA 
requires all Federal agencies to include in every proposal for major 
Federal actions significantly affecting the quality of the human 
environment, a detailed statement assessing the environmental impact 
of, and alternatives to, the proposed action and to make available to 
the public such statements. (See 42 U.S.C. 4332, 40 CFR 1506.6, and 21 
CFR 25.41(b).)
    FDA implements NEPA through its regulations in part 25 (21 CFR part 
25). Under those regulations, actions to approve NDA's, ANDA's, and 
supplements to existing approvals ordinarily require the preparation of 
an EA. (See Sec. 25.22(a)(8) and (a)(14).)
    FDA approved 141 NDA's, ANDA's, and supplemental NDA's for the 
products listed in the following table:

                                                                        
------------------------------------------------------------------------
                   Drug                          Application Number     
------------------------------------------------------------------------
Coumadin (warfarin sodium) for Injection..  09-218/S-077 and S-078      
Tavist-1 (clemastine fumarate) Tablets....  17-661/S-048                
Tavist-D (clemastine fumarate/              18-298/S-024                
 phenylpropanolamine hydrochloride)                                     
 Tablets.                                                               
Eulexin (flutamide) Capsules..............  18-554/S-014                
Nicorette (nicotine) Chewing Gum..........  18-612/S-022, 20-066/S-004  
Depakote (divalproex sodium) Tablets......  18-723/S-020                
Calcijex (calcitriol) Injection...........  18-874/S-007                
Etodolac (lodine) Capsules................  18-922/S-013                
Heparin Sodium in 5% Dextrose I.V.          19-339/S-011, S-012, S-013, 
 Infusion.                                   and S-014                  
Prinivil (lisinopril) Tablets.............  19-558/S-027                
Depakote (divalproex sodium) Sprinkle       19-680/S-008                
 Capsules.                                                              
Saizen (somatropin) for Injection.........  19-764                      
Zestril (lisinopril) Tablets..............  19-777/S-023                
Nasacort (triamcinolone acetonide)          19-798/S-006                
 Inhalation Aerosol.                                                    
Prilosec (omeprazole) Capsules............  19-810/S-033 and S-037      
Pro-amatine (midodrine hydrochloride)       19-815                      
 Tablets.                                                               
Renova (tretinoin) Cream..................  19-963                      
Aredia (pamidronate disodium) for           20-036/S-011                
 Injection.                                                             
Lioresal (baclofen) Injection.............  20-075/S-004                
Imitrex (sumatriptan succinate) Injection.  20-080/S-004                
Zofran (ondansetron hydrochloride) Tablets  20-103/S-004                
Acthrel (corticorelin ovine triflutate)     20-162                      
 for Injection.                                                         
Nilandron (nilutamide) Tablets............  20-169                      
Elmiron (pentosan polysulfate sodium)       20-193                      
 Capsules.                                                              
Zinecard (dexrazoxane) for Injection......  20-212                      
Ethyol (amifostine) for Injection.........  20-221 and 20-221/S-002     
Luvox (fluvoxamine maleate) Tablets.......  20-243/S-004                

[[Page 22961]]

                                                                        
Intralipid (fat emulsion) I.V. Infusion...  20-248                      
Voltaren XR (diclofenac sodium) Tablets...  20-254                      
Monpril HCT (fosinopril sodium/             20-286                      
 hydrochlorthiazide) Tablets.                                           
Zyloprim (allopurinol sodium) for           20-298                      
 Injection.                                                             
Fludeoxyglucose F-18 Injection............  20-306                      
Oxilan (ioxilan) Injection................  20-316                      
 Zyrtec (cetirizine hydrochloride) Syrup..  20-346                      
 Visipaque (iodixanol) Injection..........  20-351                      
 Wellbutrin (bupropion hydrochloride)       20-358                      
 Tablets.                                                               
 Myoview (technetium TC99M tetrofosmin)     20-372                      
 Injection.                                                             
 Cordarone (amiodarone hydrochloride)       20-377                      
 Injection.                                                             
 Nicotrol (nicotine) Nasal Spray..........  20-385                      
 Tiazac (diltiazem hydrochloride) Capsules  20-401                      
 Zerit (stavudine) Oral Solution..........  20-413                      
 Remeron (mirtazapine) Tablets............  20-415                      
 Feridex (ferumoxides) Injection..........  20-416                      
 Femstat (butoconazole nitrate) Vaginal     20-421                      
 Cream.                                                                 
 Azelex (azelaic acid) Cream..............  20-428                      
 Vesanoid (tretinoin) Capsules............  20-438                      
 Timolol Ophthalmic Solution..............  20-439                      
 Flolan (epoprostenol sodium) for           20-444                      
 Injection.                                                             
 Cerebyx (fosphenytoin sodium) Injection..  20-450                      
 Cytovene (ganciclovir) Capsules..........  20-460/S-005                
 Azulfidine (sulfasalazine) Tablets.......  20-465                      
 Nasacort AQ (triamcinolone acetonide)      20-468                      
 Nasal Spray.                                                           
 Claritin-D (loratadine/pseudoephedrine     20-470                      
 sulfate) Tablets.                                                      
 Tagamet HB (cimetidine hydrochloride)      20-473                      
 Tablets.                                                               
 Ultane (sevoflurane) Inhalation..........  20-478                      
 Valtrex (valacyclovir hydrochloride)       20-487                      
 Caplets.                                                               
 Corvert (ibutilide fumarate) Injection...  20-491                      
 Amaryl (glimepriride) Tablets............  20-496                      
 Actron (ketoprofen) Tablets/Caplets......  20-499                      
 Proventil HFA (albuterol sulfate)          20-503                      
 Inhalation Aerosol.                                                    
 Tiamate (diltiazem malate) Tablets.......  20-506                      
 Teczem (diltiazem malate/enalapril         20-507                      
 maleate) Tablets.                                                      
 Lac-Hydrin (ammonium lactate) Cream......  20-508                      
 Gemzar (gemcitabine hydrochloride)         20-509                      
 Injection.                                                             
 Zantac (ranitidine hydrochloride) Tablets  20-520                      
 Mentax (butenafine hydrochloride) Cream..  20-524                      
 Gyne-Lotrimin 3 (clotimazole) Vaginal      20-525                      
 Inserts.                                                               
 Conjugated estrogens/Medroxyprogesterone   20-527                      
 acetate Tablets.                                                       
 Mavik (trandolapril) Tablets.............  20-528                      
 Iontocaine (lidocaine/epinephrine)         20-530                      
 Topical Solution.                                                      
 Metrocream (metronidazole) Cream.........  20-531                      
 Ivy-Block (quaternium-18 bentonite)        20-532                      
 Lotion.                                                                
 Naropin (ropivacaine hydrochloride)        20-533                      
 Injection.                                                             
 Nicotrol (nicotine) Transdermal System...  20-536                      
 Arimidex (anastrozole) Tablets...........  20-541                      
 Dopamine hydrochloride in 5% Dextrose      20-542                      
 Injection.                                                             
 Accolate (zafirlukast) Tablets...........  20-547                      
 Flovent (fluticasone propionate)           20-548                      
 Inhalation Aerosol.                                                    
 Nimbex (cisatracurium besylate) Injection  20-551                      
 Oxycontin (oxycodone hydrochloride)        20-553                      
 Tablets.                                                               
 Dovonex (calcipotriene) Cream............  20-554                      
 Axid AR (nizatidine) Tablets.............  20-555                      
 Tritec (ranitidine bismuth citrate)        20-559                      
 Tablets.                                                               
 Humalog (insulin lispro) Injection.......  20-563                      
 Epivir (lamivudine) Tablets..............  20-564                      
 Vitrasert (ganciclovir) Implant..........  20-569                      
 Camptosar (irinotecan hydrochloride)       20-571                      
 Injection.                                                             
 Buphenyl (phenylbutyrate sodium) Tablets.  20-572                      
 Buphenyl (phenylbutyrate sodium) Oral      20-573                      
 Powder.                                                                
 Lidocaine Transoral Delivery System......  20-575                      
 Cystadane (betaine) Oral Powder..........  20-576                      
 Elliotts B Solution......................  20-577                      
 Zoladex (goserelin acetate) Implant......  20-578                      
 Lodine (etodolac) Tablets................  20-584                      
 Risperdal (risperidone) Oral Solution....  20-588                      
 Children's Advil (ibuprofen) Oral          20-589                      
 Suspension.                                                            
 Tarka (trandolapril/verapamil              20-591                      
 hydrochloride) Tablets.                                                
 Zyprexa (olanzapine) Tablets.............  20-592                      
 Epivir (lamivudine) Oral Solution........  20-596                      
 Xalatan (latanoprost) Ophthalmic Solution  20-597                      
 Rilutek (riluzole) Tablets...............  20-599                      
 Jr. Strength Motrin (ibuprofen) Caplets..  20-602                      
 Children's Motrin (ibuprofen) Oral Drops.  20-603                      
 Serostim (somatropin) for Injection......  20-604                      
 Alphagan (brimonidine tartrate)            20-613                      
 Ophthalmic Solution.                                                   
 Clonidine hydrochloride Injection........  20-615                      
 Kadian (morphine sulfate) Capsules.......  20-616                      
 Allegra (fexofenadine hydrochloride)       20-625                      
 Capsules.                                                              
 Invirase (saquinavir) Capsules...........  20-628                      
 Denavir (penciclovir) Cream..............  20-629                      

[[Page 22962]]

                                                                        
 Ultiva (remifentanil hydrochloride)        20-630                      
 Injection.                                                             
 Morphine Sulfate Injection...............  20-631                      
 Viramune (nevirapine) Tablets............  20-636                      
 Gliadel Wafer (polifeprosan 20 with        20-637                      
 carmustine) Implant.                                                   
 Tavist-D (clemastine fumerate/             20-640                      
 phenylpropanolamine hydrochloride)                                     
 Tablets.                                                               
 Claritin (loratadine) Syrup..............  20-641                      
 Eldepryl (selegiline hydrochloride)        20-647                      
 Capsules.                                                              
 Norvir (ritonavir) Oral Solution.........  20-659                      
 Albenza (albendazole) Tablets............  20-666                      
 Hycamtin (topotecan hydrochloride)         20-671                      
 Injection.                                                             
 Norvir (ritonavir) Capsules..............  20-680                      
 Crixivan (indinavir sulfate) Capsules....  20-685                      
 Dexferrum (iron dextran) Injection.......  40-024                      
 Blenoxane (bleomycin sulfate) for          50-443/S-025                
 Injection.                                                             
 Maxipime (cefepime hydrochloride) for      50-679                      
 Injection.                                                             
 Daunoxome (liposomal daunorubicin)         50-704                      
 Injection.                                                             
 Merrem (meropenem) Injection.............  50-706                      
 Doxil (liposomal doxorubicin) Injection..  50-718                      
 Augmentin (amoxicillin/clavulanic acid)    50-720                      
 Tablet.                                                                
 Biaxin (clarithromycin) Tablets..........  50-721                      
 Abelcet (amphotericin B lipid complex)     50-724/S-002                
 Injection.                                                             
 Augmentin (amoxicillin/clavulanate         50-725                      
 potassium) Oral Suspension.                                            
 Augmentin (amoxicillin/clavulanate         50-726                      
 potassium) Tablets.                                                    
 Zithromax (azithromycin) Tablets.........  50-730                      
------------------------------------------------------------------------

    As part of its review of each of the NDA's, ANDA's, and supplements 
listed in this table, FDA reviewed an EA. In each instance, FDA found 
that the approval of the NDA, ANDA, or supplement will not 
significantly affect the human environment. In accordance with the 
Council on Environmental Quality regulations in 40 CFR 1501.4(e) and 
FDA regulations in Sec. 25.32, FDA prepared a FONSI for each NDA, ANDA, 
and supplement. This notice announces that the EA's and FONSI's for 
these human drug products may be seen in the Dockets Management Branch 
(address above) between 9 a.m. and 4 p.m., Monday through Friday. For a 
fee, copies of these EA's and FONSI's may be obtained by writing the 
Freedom of Information Staff (address above). The request should 
identify by the application number the EA's and FONSI's requested. 
Separate requests should be submitted for each application number. For 
additional information regarding the submission of freedom of 
information requests, call 301-443-6310.

    Dated: April 21, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-10911 Filed 4-25-97; 8:45 am]
BILLING CODE 4160-01-F