[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:
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Drug NDA
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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