[Federal Register Volume 61, Number 184 (Friday, September 20, 1996)]
[Notices]
[Pages 49470-49472]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-24149]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0310]


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 reviewed environmental assessments (EA's) and issued findings

[[Page 49471]]

of no significant impact (FONSI's) relating to the 51 new drug 
applications (NDA's) or supplements 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 and supplements 
to existing approvals ordinarily require the preparation of an EA. (See 
Sec. 25.22(a)(8) and (a)(14).)
    FDA approved 51 NDA's or supplemental NDA's for the products listed 
in the following table:

------------------------------------------------------------------------
                Drug                                  NDA               
------------------------------------------------------------------------
Versed (midazolam) Injection          18-654/S-026                      
Zantac (ranitidine hydrochloride)     18-703/S-051                      
 Tablets                                                                
Zantac (ranitidine hydrochloride)     19-675/S-016                      
 Syrup                                                                  
Prilosec (omeprazole) Capsules        19-810/S-019                      
Zyrtec (cetirizine hydrochloride)     19-835                            
 Tablets                                                                
Zofran (ondansetron hydrochloride)    20-007/S-005 and S-018            
 Injection                                                              
Paxil (paroxetine hydrochloride)      20-031/S-007 and S-009            
 Tablets                                                                
Thioplex (thiotepa) Injection         20-058                            
Habitrol (nicotine transdermal)        20-076/S-006                     
Zantac (ranitidine hydrochloride)     20-095                            
 Capsules                                                               
Flonase (fluticasone propionate)      20-121                            
 Nasal Spray                                                            
Imitrex (sumatriptan succinate)       20-132                            
 Tablets                                                                
Effexor (venlafaxine hydrochloride)   20-151                            
 Tablets                                                                
Serzone (nefazodone hydrochloride)    20-152                            
 Tablets                                                                
Perindopril Erbumine Tablets          20-184                            
Prozac (fluoxetine hydrochloride)     20-187                            
 Capsules/Oral Solution                                                 
Ultravist (iopromide) Injection       20-220                            
Tagamet (cimetidine) Tablets          20-238                            
Renormax (spirapril hydrochloride)     20-240                           
 Tablets                                                                
Lamictal (lamotrigine) Tablets        20-241                            
Luvox (fluvoxamine maleate) Tablets   20-243                            
Neurolite (bicisate dihydrochloride)  20-256                            
 Injection                                                              
Risperdal (risperidone) Caplets       20-272                            
Ultram (tramadol hydrochloride)       20-281                            
 Tablets                                                                
Coreg (carvedilol) Tablets             20-297                           
Trasylol (aprotinin) Injection        20-304                            
Univasc (moexipril hydrochloride)     20-312                            
 Tablets                                                                
Pepcid AC (famotidine) Tablets        20-325                            
Primacor (milrinone lactate)           20-343                           
 Injection                                                              
Sular (nisoldipine) ER Tablets        20-356                            
Glucophage (metformin hydrochloride)  20-357                            
 Tablets                                                                
Famvir (famiciclovir) Tablets         20-363                            
Cozaar (lorsartan potassium) Tablets  20-386                            
Hyzaar (losartan K/                   20-387                            
 hydroclorothiazide) Tablets                                            
Navelbine (vinorelbine tartrate)      20-388                            
 Injection                                                              
Atrovent (ipratropium bromide) Nasal  20-393                            
 Spray                                                                  
Atrovent (ipratropium bromide) Nasal  20-394                            
 Spray                                                                  
Prevacid (lansoprazole) Capsules      20-406                            
Trusopt (dorzolamide HCl) Ophthalmic   20-408                           
 Solution                                                               
Photofrin (porfirmer sodium)          20-451                            
 Injection                                                              
Precose (acabrose) Tablets             20-482                           
Casodex (bicalutamide) Tablets        20-498                            
Zantac (ranitidine hydrochloride)      20-520                           
 Tablets                                                                
Fosamax (alendronate sodium) Tablets  20-560                            
Dynabac (dirithromycin) Tablets       50-678                            
Cedax (ceftibuten) Capsules           50-685                            
Cedax (ceftibuten) Capsules           50-686                            
Neoral (cyclosporine microemulsion)   50-715                            
 Gel                                                                    
Neoral (cyclosporine microemulsion)   50-716                            
 Oral                                                                   
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    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. 25.32, 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

[[Page 49472]]

be obtained by writing the Freedom of Information Staff (address 
above). The request should identify by the NDA number the EA's and 
FONSI's requested. Separate requests should be submitted for each NDA. 
For additional information regarding the submission of freedom of 
information requests call 301-443-6310.

    Dated: September 13, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-24149 Filed 9-19-96; 8:45 am]
BILLING CODE 4160-01-F