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;