27300 Federal Register / Vol. 63, No. 95 / Monday, May 18, 1998 / Notices

application which includes

requirements that an applicant

document that the disease is rare (affects

fewer than 200,000 persons in the

United States annually) or that the

sponsor of the drug has no reasonable

expectation of recovering costs of

research and development of the drug.

Section 316.26 allows an applicant to

amend the application under certain

circumstances. Section 316.30 requires

submission of annual reports, including

progress reports on studies, a

description of the investigational plan,

and a discussion of changes that may

affect orphan status. The information

requested will provide the basis for an

FDA determination that the drug is for

a rare disease or condition and satisfies

the requirements for obtaining ophan

drug status. Secondly, the information

will describe the medical and regulatory

history of the drug. The respondents to

this collection of information are

biotechnology firms, drug companies,

and academic clinical researchers. FDA

estimates the burden of this collection

of information as follows:

TABLE 1.—Estimated Annual Reporting Burden1

21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

316.10, 316.12, and 316.14 0 0 0 0 0

316.20, 316.21, and 316.26 90 1.78 160.20 125 20,025

316.22 5 1 5 2 10

316.27 5 1 5 4 20

316.30 450 1 450 2 900

316.36 .2 3 .6 15 9

Total Burden Hours .......................... .......................... .......................... .......................... 20,964

1There are no capital costs or operating and maintenance costs associated with this collection of information.

The information requested from

respondents represents, for the most

part, an accounting of information

already in possession of the applicant.

It is estimated, based on the frequency

of requests over the past 5 years, that 90

persons or organizations per year will

request orphan drug designation and

that no requests for recommendations

on design of preclinical or clinical

studies will be received. Based upon

FDA experience over the last decade,

FDA estimates that the effort required to

prepare applications to receive

consideration for sections 525 and 526

of the act (§§ 316.10, 316.12, 316.20, and

316.21) is generally similar and is

estimated to require an average of 95

hours of professional staff time and 30

hours of support staff time per

application. Estimates of annual activity

and burden for foreign sponsor

nomination of a resident, agent, change

in ownership or designation, and

inadequate supplies of drug in

exclusivity, are based on total

experience by FDA with such requests

since 1983.

Dated: May 8, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–13042 Filed 5–15–98; 8:45 am]

BILLING CODE 4160–01–F

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 § 25.20(l).)

FDA approved 167 NDA’s and

supplemental NDA’s and ANDA’s for

the products listed in the following

table:
Federal Register / Vol. 63, No. 95 / Monday, May 18, 1998 / Notices 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 Aerosol 20–486

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 Injection 20–570

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
27302 Federal Register / Vol. 63, No. 95 / Monday, May 18, 1998 / Notices

Drug Application Number

Dovonex (calcipotriene) Solution 20–611

Pytest (C–14 urea) Capsules 20–617

Betoptic Pilo (betaxolol hydrochloride/pilocarpine hydrochloride) Suspension20–619

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) Capsules 20–632

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 in dextrose with

calcium) Injection

20–678

Ortho Tri-Cyclen (norgestimate/ethinyl estradiol) Tablets 20–681

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) Tablets 20–729

Clinimix Sulfite-free (amino acid in dextrose) Injection 20–734

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
Federal Register / Vol. 63, No. 95 / Monday, May 18, 1998 / Notices 27303

Drug Application Number

Cipro (ciprofloxacin) for Suspension 20–780

Allegra-D (fexofenadine hydrochloride/pseudoephedrine hydrochloride)

Tablets

20–786

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 tablets, and tetracycline hydrochloride capsules)50–719

Cellcept (mycophenolate mofetil) Tablets 50–723

Amphotec (amphotericin B) Cholesteryl Sulfate for Injection 50–729

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 § 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 http://

www.fda.gov/opacom/backgrounders/

foiahand.html.

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

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0486]

Agency Information Collection

Activities; Announcement of OMB

Approval

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Registration of Producers of Drugs and

Listing of Drugs in Commercial

Distribution’’ has been approved by the

Office of Management and Budget

(OMB) under the Paperwork Reduction

Act of 1995 (the PRA).

FOR FURTHER INFORMATION CONTACT:

Karen L. Nelson, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1482.

SUPPLEMENTARY INFORMATION: In the

Federal Register of December 11, 1997

(62 FR 65274), the agency announced

that the proposed information collection

had been submitted to OMB for review

and clearance under section 3507 of the

PRA (44 U.S.C. 3507). An agency may

not conduct

or sponsor, and a person is not required

to respond to, a collection of

information unless it displays a

currently valid OMB control number.

OMB has now approved the information

collection and has assigned OMB

control number 0910–0045. The

approval expires on April 30, 2001.

Dated: May 7, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–13044 Filed 5–15–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–339]

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

AGENCY: Health Care Financing

Administration.

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding this burden

estimate or any other aspect of this

collection of information, including any

of the following subjects: (1) The

necessity and utility of the proposed

information collection for the proper

performance of the agency’s functions;