[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
