[Federal Register Volume 59, Number 178 (Thursday, September 15, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-22761]


[[Page Unknown]]

[Federal Register: September 15, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94N-0271]

 

Environmental Assessments and Findings of No Significant Impact

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that it 
has received environmental assessments (EA's) and issued findings of no 
significant impact (FONSI's) relating to the approval of 42 new drug 
applications (NDA's) listed in the table below. FDA is publishing this 
notice because Federal regulations require this information to be 
available to the public for inspection.

ADDRESSES: The EA's and FONSI's may be seen in the Dockets Management 
Branch (HFA-305), Food and Drug Administration, rm. 1-23, 12420 
Parklawn Dr., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Christina L. Good, Center for Drug 
Evaluation and Research (HFD-102), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-6758.

SUPPLEMENTARY INFORMATION: The National Environmental Policy Act (NEPA) 
requires all Federal agencies 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).) 
Under NEPA, all Federal agencies must assess the possible environmental 
impact of, and alternatives to, major Federal actions significantly 
affecting the environment, and such assessments are to be made 
available to the public. (See 42 U.S.C. 4332, 40 CFR 1506.6, and 21 CFR 
25.1(b).)
    FDA implements NEPA through its regulations at 21 CFR part 25. 
Under those regulations, the approval of an NDA usually constitutes an 
action that requires the preparation of an EA. (See 21 CFR 
25.22(a)(14).)
    FDA recently approved 42 NDA's pertaining to the following products 
as listed in the table below:

------------------------------------------------------------------------
                         Drug                                NDA no.    
------------------------------------------------------------------------
 Claritin (loratadine) Tablets.......................  NDA 19-658       
 Ambiem (zolpidem tartrate) Tablets..................  NDA 19-908       
 Manoplax (flosequinan) Tablets......................  NDA 19-960       
 Mannitol Injection (Excel Plastic Containers).......  NDA 20-006       
 Maxaquin (lomefloxacin hydrochloride) Tablets.......  NDA 20-013       
 Paroxetine (paroxetine hydrochloride) Tablets.......  NDA 20-031       
 Desogen (desogestrel and ethinyl estrodiol) Tablets.  NDA 20-071       
 Imitrex (sumatriptan succinate).....................  NDA 20-080       
 I-131 MIBG (iobenguane sulfate I 131) Injection.....  NDA 20-084       
 Imagent GI (perflubron).............................  NDA 20-091       
 Zofran (ondansetron hydrochloride) Tablets..........  NDA 20-103       
 Oncopent (pentostatin) for Injection................  NDA 20-122       
 Prohance (gadoteridol) Injection....................  NDA 20-131       
 Metastron (strontium chloride SR 89) Injection......  NDA 20-134       
 Demadex (torsemide) Tablets.........................  NDA 20-136       
 Demadex (torsemide) Injection.......................  NDA 20-137       
 Lovenox (enoxaparin sodium) Injection...............  NDA 20-164       
 Proscar (finasteride) Tablets.......................  NDA 20-180       
 Felbatol (felbamate) Tablets and Suspension.........  NDA 20-189       
 Alomide (lodoxamide tromethamine) Sterile Ophthalmic  NDA 20-191       
 Solution 0.1%.                                                         
 Lamisil (terbinafine hydrochloride) Topical Cream 1%  NDA 20-192       
 Hivid (zalcitabine) Tablets.........................  NDA 20-199       
 Dobutamine in 5% Dextrose Injection in Polyester CR3  NDA 20-201       
 Flexible Containers.                                                   
 Alkeran (melphalan hydrochloride) for Injection.....  NDA 20-207       
 Propulsid (cisapride) Tablets.......................  NDA 20-210       
 Atrovent (ipratropium bromide) Inhalation Solution..  NDA 20-228       
 Leustatin (cladribine) for Injection................  NDA 20-229       
 Rhinocort (budesonide) Nasal Inhaler................  NDA 20-233       
 Neurontin (gabapenton) Capsules.....................  NDA 20-235       
 Serevent (salmeterol xinafoate) Inhalation Aerosol..  NDA 20-236       
 Mepron (atovaquone) Tablets.........................  NDA 20-259       
 LesCol (fluvastatin sodium) Capsules................  NDA 20-261       
 Dobutamine in 5% Dextrose Injection in Glass          NDA 20-269       
 Containers.                                                            
 Fragmin (dalteparin sodium) Injection...............  NDA 20-287       
 Octreoscan (kit for the preparation of Indium IN-111  NDA 20-314       
 pentetreotide) Injection.                                              
 Orlaam (levomethadyl acetate hydrochloride) Oral      NDA 20-315       
 Solution.                                                              
 Temovate (clobetasol propionate) Emollient Cream....  NDA 20-340       
 Cerezyme (imiglucerase) for Injection...............  NDA 20-367       
 Zerit (stavudine) Capsules..........................  NDA 20-412       
 Zosyn (sterile piperacillin sodium/tazobactam         NDA 50-684       
 sodium).                                                               
 Mycobutin (rifabutin) Capsules......................  NDA 50-689       
 Biaxin (clarithromycin) Granules for Oral Suspension  NDA 50-698       
------------------------------------------------------------------------

    FDA has reviewed the EA's submitted for each of the NDA's in the 
table of this document and has determined that approval of these NDA's 
will not significantly affect the human environment. Therefore, under 
21 CFR 25.32, the agency has prepared a FONSI for each of these NDA's 
and no environmental impact statements are required. 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.

    Dated: September 6, 1994.
William K. Hubbard,
Interim Deputy Commissioner for Policy.
[FR Doc. 94-22761 Filed 9-14-94; 8:45 am]
BILLING CODE 4160-01-F