[Federal Register Volume 63, Number 95 (Monday, May 18, 1998)]
[Notices]
[Pages 27300-27303]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-13045]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98N-0286]


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 167 new drug applications 
(NDA'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, 301-594-5629.

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 25.51(b).)
    FDA implements NEPA through its regulations in part 25 (21 CFR part 
25). Under those regulations, actions to approve NDA's, abbreviated new 
drug applications (ANDA's), and supplements to existing approvals 
ordinarily require the preparation of an EA. (See Sec. 25.20(l).)
    FDA approved 167 NDA's and supplemental NDA's and ANDA's for the 
products listed in the following table:

[[Page 27301]]



                                                                                                                
----------------------------------------------------------------------------------------------------------------
                          Drug                                              Application Number                  
----------------------------------------------------------------------------------------------------------------
Klonopin (clonazepam) Tablets                            17-533/S-023                                           
Ativan (lorazepam) Injection                             18-140/S-003                                           
Rythmol (propafenone hydrochloride) Tablets              19-151/S-002                                           
Novantrone (mitoxantrone hydrochloride) for Injection    19-297/S-014                                           
Actigall (ursodiol) Capsules                             19-594/S-016                                           
Humatrope (somatropin) for Injection                     19-640/S-013 and S-018                                 
Asacol (mesalamine) Tablets                              19-651/S-005                                           
Tilade (nedocromil sodium) Inhalation Aerosol            19-660/S-015                                           
Zoladex (goserelin acetate) Implant                      19-726/S-018                                           
Prilosec (omeprazole) Capsules                           19-810/S-036                                           
Soriatane (acitretin) Capsules                           19-821                                                 
Zoloft (sertraline hydrochloride) Tablets                19-839/S-002 and S-011                                 
Corlopam (fenoldopam mesylate) for Injection             19-922                                                 
Zofran (ondansetron hydrochloride) Tablets               20-103/S-005                                           
Astelin (azelastine hydrochloride) Nasal Spray           20-114                                                 
Migranal (dihydroergotamine mesylate) Nasal Spray        20-148                                                 
Lovenox (enoxaparin sodium) Injection                    20-164/S-008                                           
Nicoderm (nicotine) Transdermal                          20-165/S-011                                           
Imdur (isosorbide mononitrate) Tablets                   20-225                                                 
Normiflo (ardeparin sodium) Injection                    20-227                                                 
Tegretol-XR (carbamazepine) Tablets                      20-234                                                 
Lescol (fluvastatin sodium) Capsules                     20-261/S-012                                           
Junior Strength Advil (ibuprofen) Tablets                20-267                                                 
Genotropin (somatropin) for Injection                    20-280/S-008                                           
Coreg (carvedilol) Tablets                               20-297/S-001                                           
Kytril (granisetron hydrochloride) Tablets               20-305                                                 
Nizoral A-D (ketoconazole) Shampoo                       20-310                                                 
Agrelin (anagrelide hydrochloride) Capsules              20-333                                                 
Famvir (famciclovir) Tablets                             20-363/S-012                                           
Niaspan (niacin) Tablets                                 20-381                                                 
Zanaflex (tizanidine hydrochloride) Tablets              20-397                                                 
Zofran (ondansetron hydrochloride) Injection             20-403                                                 
Avita (tretinoin) Cream                                  20-404                                                 
Lanoxin (digoxin) Tablets                                20-405                                                 
Prevacid (lansoprazole) Capsules                         20-406/S-010 and S-011                                 
Gastromark (ferumoxsil) Suspension                       20-410                                                 
Genesa (arbutamine hydrochloride) Injection              20-420                                                 
Orgaran (danaparoid sodium) Injection                    20-430                                                 
Pulmicort (budenoside) for Inhalation                    20-441                                                 
Imodium A-D (loperamide hydrochloride) Tablets           20-448                                                 
Pandel (hydrocortisone buteprate) Cream                  20-453                                                 
Galzin (zinc acetate) Capsules                           20-458                                                 
Nasalcrom (cromolyn sodium) Nasal Spray                  20-463                                                 
Nasacort AQ (triamcinolone acetonide) Nasal Spray        20-468/S-002                                           
Zyflo (zileuton) Tablets                                 20-471                                                 
Retin-A Micro (tretinoin) Gel                            20-475                                                 
Vanceril (beclomethasone dipropionate) Inhalation        20-486                                                 
 Aerosol                                                                                                        
Alphagen (brimonidine tartrate) Solution                 20-490                                                 
Fareston (toremifene citrate) Tablets                    20-497                                                 
Transderm Scop (scopolamine) Transdermal                 20-501                                                 
Hydrochlorothiazide Capsules                             20-504                                                 
Topamax (topiramate) Tablets                             20-505                                                 
Aphthasol (amlexanox) Paste                              20-511                                                 
Lupron Depot (leuprolide acetate) for Injection          20-517/S-002                                           
Retrovir (zidovudine) Tablets                            20-518                                                 
Loprox (ciclopirox) Gel                                  20-519                                                 
Condylox (podofilox) Gel                                 20-529                                                 
Duract (bromfenac sodium) Capsules                       20-535                                                 
Norplant II (levonorgestrel) Implant                     20-544                                                 
Flovent (fluticasone propionate) for Inhalation          20-549                                                 
Valtrex (valacyclovir hydrochloride) Caplets             20-550/S-003                                           
Fosamax (alendronate sodium) Tablets                     20-560/S-003                                           
Quadramet (samarium sm-153 lexidronam pentasodium) for   20-570                                                 
 Injection                                                                                                      
Flomax (tamsulosin hydrochloride) Capsules               20-579                                                 
Cotazym (pancrelipase) Capsules                          20-580                                                 
Follistim (follitropin) for Injection                    20-582                                                 
Depacon (valproate sodium) Injection                     20-593                                                 
Tazorac (tazarotene) Gel                                 20-600                                                 
Junior Strength Motrin (ibuprofen) Tablets               20-601                                                 
Zofran (ondansetron hydrochloride) Solution              20-605                                                 
Imodium (loperamide hydrochloride/simethicone) Tablets   20-606                                                 
Arthrotec (diclofenac sodium/misoprostol) Tablets        20-607                                                 

[[Page 27302]]

                                                                                                                
Dovonex (calcipotriene) Solution                         20-611                                                 
Pytest (C-14 urea) Capsules                              20-617                                                 
Betoptic Pilo (betaxolol hydrochloride/pilocarpine       20-619                                                 
 hydrochloride) Suspension                                                                                      
Copaxone (copolymer-1) for Injection                     20-622                                                 
Anzemet (dolasetron mesylate) Tablets                    20-623                                                 
Anzemet (dolasetron mesylate) Injection                  20-624                                                 
Imitrex (sumatriptan) Nasal Spray                        20-626                                                 
Meridia (sibutramine hydrochloride monohydrate)          20-632                                                 
 Capsules                                                                                                       
Levaquin (levofloxacin) Tablets                          20-634                                                 
Levaquin (levofloxacin) Injection                        20-635                                                 
Seroquel (quetiapine fumarate) Tablets                   20-639                                                 
Gabitril (tiagabine hydrochloride) Tablets               20-646                                                 
Diastat (diazepam) Gel                                   20-648                                                 
Edex (alprostadil) for Injection                         20-649                                                 
Teslascan (mangafodipir trisoodium) Injection            20-652                                                 
Alora (estradiol) Transdermal                            20-655                                                 
Sporanox (itraconazole) Solution                         20-657                                                 
Requip (ropinirole hydrochloride) Tablets                20-658                                                 
Butenafine Hydrochloride Cream                           20-663                                                 
Dostinex (cabergoline) Tablets                           20-664                                                 
Diovan (valsartan) Capsules                              20-665                                                 
Mirapex (pramipexole) Tablets                            20-667                                                 
Lexxel (enalapril maleate/felodipine) Tablets            20-668                                                 
Zagam (sparfloxacin) Tablets                             20-677                                                 
Clinimix E Sulfite-free (amino acid with electrolytes    20-678                                                 
 in dextrose with calcium) Injection                                                                            
Ortho Tri-Cyclen (norgestimate/ethinyl estradiol)        20-681                                                 
 Tablets                                                                                                        
Glyset (miglitol) Tablets                                20-682                                                 
Alesse (ethinyl estradiol/levonorgestrel) Tablets        20-683                                                 
Lumenhance (manganese chloride tetrahydrate) Solution    20-686                                                 
Patanol (olopatadine hydrochloride) Solution             20-688                                                 
Posicor (mibefradil dihydrochloride) Tablets             20-689                                                 
Aricept (donepezil hydrochloride) Tablets                20-690                                                 
Serevent (salmeterol xinafoate) for Inhalation           20-692                                                 
Sporanox (itraconazole) Capsules                         20-694                                                 
Raxar (grepafloxacin hydrochloride) Tablets              20-695                                                 
Effexor XR (venlafaxine hydrochloride) Capsules          20-699                                                 
Muse (alprostadil) Suppository                           20-700                                                 
Crinone (progesterone) Gel                               20-701                                                 
Lipitor (atorvastatin calcium) Tablets                   20-702                                                 
Claritin EZ (loratadine) Tablets                         20-704                                                 
Rescriptor (delavirdine mesylate) Tablets                20-705                                                 
Emadine (emedastine difumarate) Solution                 20-706                                                 
Skelid (tiludronate disodium) Tablets                    20-707                                                 
Lupron Depot (leuprolide acetate) for Injection          20-708                                                 
Paxil (paroxetine hydrochloride) Suspension              20-710                                                 
Zyban (bupropion hydrochloride) Tablets                  20-711                                                 
Carbatrol (carbamazepine) Capsules                       20-712                                                 
Nicotrol (nicotine) for Inhalation                       20-714                                                 
Vicoprofen (hydrocodone bitartrate/ibuprofen) Tablets    20-716                                                 
Prelay (troglitazone) Tablets                            20-719                                                 
Rezulin (troglitazone) Tablets                           20-720                                                 
Aldara (imiquimod) Cream                                 20-723                                                 
Femara (letrozole) Tablets                               20-726                                                 
Uniretic (moexipril hydrochloride/hydrochlorothiazide)   20-729                                                 
 Tablets                                                                                                        
Clinimix Sulfite-free (amino acid in dextrose)           20-734                                                 
 Injection                                                                                                      
Teveten (eprosartan mesylate) Tablets                    20-738                                                 
Baycol (cerivastatin) Tablets                            20-740                                                 
BSS (balanced salt) Solution                             20-742                                                 
Noritate (metronidazole) Cream                           20-743                                                 
Tilade (nedocromil sodium) Inhalation Solution           20-750                                                 
Crinone (progesterone) Gel                               20-756                                                 
Avapro (irbesartan) Tablets                              20-757                                                 
Irbesartan/hydrochlorthiazide Tablets                    20-758                                                 
Trovan (trovafloxacin mesylate) Tablets                  20-759                                                 
Trovan (alatrovafloxacin mesylate) Injection             20-760                                                 
Nasonex (mometasone furoate) Nasal Spray                 20-762                                                 
Propulsid Quicksolv (cisapride) Tablets                  20-767                                                 
Zomig (zolmitriptan) Tablets                             20-768                                                 
Viracept (nelfinavir mesylate) for Solution              20-778                                                 
Viracept (nelfinavir mesylate) Tablets                   20-779                                                 

[[Page 27303]]

                                                                                                                
Cipro (ciprofloxacin) for Suspension                     20-780                                                 
Allegra-D (fexofenadine hydrochloride/pseudoephedrine    20-786                                                 
 hydrochloride) Tablets                                                                                         
Cardizem (diltiazem hydrochloride) for Injection         20-792                                                 
Floxin (ofloxacin) Solution                              20-799                                                 
Fortovase (saquinavir) Capsules                          20-828                                                 
Prograf (tacrolimus) Capsules                            50-708                                                 
Prograf (tacrolimus) Capsules                            50-708/S-008                                           
Helidac (bismuth subsalicylate tablets, metronidazole    50-719                                                 
 tablets, and tetracycline hydrochloride capsules)                                                              
Cellcept (mycophenolate mofetil) Tablets                 50-723                                                 
Amphotec (amphotericin B) Cholesteryl Sulfate for        50-729                                                 
 Injection                                                                                                      
Zithromax (azithromycin) for Injection                   50-733                                                 
Idamycin-PFS (idarubicin hydrochloride) Injection        50-734                                                 
Neoral (cyclosporine) Capsules                           50-735                                                 
Neoral (cyclosporine) Solution                           50-736                                                 
Neoral (cyclosporine) Capsules                           50-737                                                 
Neoral (cyclosporine) Solution                           50-738                                                 
Omnicef (cefdinar) Capsules                              50-739                                                 
Ambisome (amphotericin B) Liposome for Injection         50-740                                                 
Stromectol (ivermectin) Tablets                          50-742                                                 
Bactroban (mupirocin calcium) Cream                      50-746                                                 
Omnicef (cefdinir) Suspension                            50-749                                                 
Primsol (trimethoprim hydrochloride) Solution            74-374/S-002                                           
----------------------------------------------------------------------------------------------------------------

    As part of its review of each of the NDA's and supplements listed 
in this table, FDA reviewed an EA. In each instance, FDA found that the 
approval of the NDA 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. 25.41, FDA prepared a FONSI for each NDA 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. Additional information 
regarding the submission of freedom of information requests is 
available on the Internet at <a href="http://www.fda.gov/opacom/backgrounders/
foiahand.html">http://www.fda.gov/opacom/backgrounders/
foiahand.html</a>.

    Dated: May 7, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-13045 Filed 5-15-98; 8:45 am]
BILLING CODE 4160-01-F