11106 Federal Register / Vol. 60, No. 40 / Wednesday, March 1, 1995 / Notices

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 95D–0002]

Memorandum on the Use of an FDA

Cleared or Approved Sterile

Connecting Device in Blood Bank

Practice; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a memorandum dated

August 5, 1994, to all registered blood

establishments. In the August 5, 1994,

memorandum, the Center for Biologics

Evaluation and Research (CBER)

recommends practices and procedures

in the use of sterile connecting devices

(STCD’s). CBER also advises that certain

uses of these devices may create a new

product or significantly modify a

regulated product, such that approval of

a license application or an application

supplement is required. This

memorandum provides information to

registered blood establishments on the

use of STCD’s.

DATES: Written comments may be

submitted at any time.

ADDRESSES: Submit written requests for

single copies of the memorandum to the

Congressional and Consumer Affairs

Branch (HFM–12), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448. Send two

self-addressed adhesive labels to assist

that office in processing your requests.

Persons with access to INTERNET may

request this document from ‘‘Mem8—

05—94@A1.cber.fda.gov’’. The

document may also be obtained by

calling CBER FAX Information System

at 301–594–1939 from a FAX machine

with a touch tone phone attached or

built in. Submit written comments on

the memorandum to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, rm. 1–23,

12420 Parklawn Dr., Rockville, MD

20857. Two copies of any comments are

to be submitted, except that individuals

may submit one copy. Requests and

comments should be identified with the

docket number found in brackets in the

heading of this document. The

memorandum and received comments

are available for public examination in

the Dockets Management Branch

(address above) between 9 a.m. and 4

p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT:

Betty J. Poindexter, Center for Biologics

Evaluation and Research (HFM–335),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–496–2577.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of a

memorandum to all registered blood

establishments on the use of an FDA

cleared or approved STCD. STCD’s

produce sterile welds between two

pieces of compatible tubing. This

procedure permits sterile connection of

a variety of containers and/or needles.

This document describes recommended

practices and procedures for the use of

these devices.

The memorandum provides guidance

on the common uses of STCD’s as

follows: (1) Adding a new or smaller

needle to a blood collection set; (2)

preparing components; (3) pooling

blood products; (4) preparing an aliquot

for pediatric use and divided units; (5)

connecting additional saline or

anticoagulant lines during an automated

plasmapheresis procedure; (6) attaching

processing solutions; (7) adding an

FDA-cleared leukocyte reduction filter;

and (8) removing samples from blood

product containers for testing.

The memorandum also presents

general guidance as well as specific

information and examples concerning

specifications for submission of

applications and application

supplements to FDA addressing the use

of a STCD. It also includes an appendix

with the currently approved dating

periods for blood components and

source plasma (21 CFR 610.53) and

currently recommended dating periods

for automated plateletpheresis products

(see Revised Guideline for Collection of

Platelets, Pheresis (54 FR 3852, January

26, 1989)).

As with other memoranda, FDA does

not intend this document to be allinclusive and cautions that not all

information may be applicable to all

situations. The memorandum is

intended to provide information and

does not set forth new requirements.

The procedures cited in the

memorandum are recommendations.

FDA anticipates that blood

establishments may develop alternative

procedures and discuss them with FDA.

FDA may find those alternative

procedures acceptable. FDA recognizes

that advances may continue in the use

of STCD’s and that this document may

become outdated as those advances

occur. The memorandum does not bind

FDA and does not create or confer any

rights, privileges, or benefits on or for

any private person, but is intended

merely for guidance.

Interested persons may, at any time,

submit to the Dockets Management

Branch (address above) written

comments on the memorandum. Two

copies of any comments are to be

submitted, except that individuals may

submit one copy. Comments are to be

identified with the docket number

found in brackets in the heading of this

document. Received comments may be

seen in the Dockets Management Branch

between 9 a.m. and 4 p.m., Monday

through Friday.

Received comments will be

considered in determining whether

further revisions to the memorandum

are warranted.

Dated: February 17, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95–5061 Filed 2–28–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95N–0051]

Solvay Pharmaceuticals, Inc., et al.;

Withdrawal of Approval of 11

Abbreviated Antibiotic Applications

and 11 Abbreviated New Drug

Applications

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is withdrawing

approval of 11 abbreviated antibiotic

applications (AADA’s) and 11

abbreviated new drug applications

(ANDA’s). The holders of the

applications notified the agency in

writing that the drug products were no

longer marketed and requested that the

approval of the applications be

withdrawn.

EFFECTIVE DATE: March 31, 1995.

FOR FURTHER INFORMATION CONTACT: Lola

E. Batson, Center for Drug Evaluation

and Research (HFD–360), Food and

Drug Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1038.

SUPPLEMENTARY INFORMATION: The

holders of the applications listed in the

table in this document have informed

FDA that these drug products are no

longer marketed and have requested that

FDA withdraw approval of the

applications. The applicants have also,

by their request, waived their

opportunity for a hearing.
Federal Register / Vol. 60, No. 40 / Wednesday, March 1, 1995 / Notices 11107

AADA No. Drug Applicant

60–128 Ampicillin Trihydrate ........................................................... IBI, Giovanni Lorenzini S.p.A., 20139 Milano, Italy.

60–130 Ampicillin ............................................................................ Do.

61–659 Erythromycin Delayed-Release Tablets, U.S.P., 250 milligrams (mg) ..................................................................... Solvay Pharmaceuticals, Inc., 901 Sawyer Rd., Marietta,

GA 30062.

61–818 Cephalexin Monohydrate ................................................... IBI.

61–923 Amoxicillin Trihydrate ......................................................... Do.

62–052 Nystatin Ointment, U.S.P. .................................................. Lemmon Co., 650 Cathill Rd., Sellersville, PA 18960.

62–430 Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment, U.S.P. ................................................................... Pharmafair, Inc., 110 Kennedy Dr., Hauppauge, NY

11788.

62–449 Cephalothin Sodium ........................................................... IBI.

62–666 Cephalothin Sodium for Injection, U.S.P., 1 gram (g) and

2 g ................................................................................... Fujisawa USA, Inc., Parkway North Center, Three Parkway North, Deerfield, IL 60015–2548

62–710 Cephalothin Sodium ........................................................... IBI.

62–747 Clindamycin Phosphate Injection, U.S.P., 150 mg/milliliters (mL) ........................................................................ Fujusawa USA, Inc.

ANDA No. Drug Applicant

80–041 Trisulfapyrimidines Oral Suspension, U.S.P., 0.5 g/5 mL .. Solvay Pharmaceuticals, Inc.

80–921 Vitamin A Capsules, U.S.P., 50,000 units ......................... Lemmon Co.

83–993 Phendimetrazine Tartrate Tablets, U.S.P., 35 mg ............. Solvay Pharmaceuticals, Inc.

84–435 Meprobamate Tablets, U.S.P., 200 mg .............................. Do.

85–897 Phendimetrazine Tartrate Capsules, U.S.P., 35 mg .......... Do.

87–074 Diatrizoate Meglumine and Diatriozoate Sodium Injectin,

U.S.P. .............................................................................. Mallinckrodt Medical, Inc., P.O. Box 5840, St. Louis, MO

63134.

87–113 Triamcinolone Acetonide Cream, U.S.P. 0.1% .................. Solvay Pharmaceuticals, Inc.

87–210 Reserpine, Hydralazine Hydrochloride, and

Hydrochlorothiazide Tablets, U.S.P., 0.1 mg/25 mg/15

mg ................................................................................... Do.

87–833 Prednisone Tablets, U.S.P., 25 mg .................................... Roxane Laboratories, Inc., P.O. Box 16532, Columbus,

OH 43216–6532

88–071 Dexamethasone Sodium Phosphate Ophthalmic Ointment, U.S.P., 0.05% ....................................................... Pharmafair, Inc.

88–612 Phentermine Hydrochloride Capsules, U.S.P., 30 mg ....... Lemmon Co.

Therefore, under section 505(e) of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 355(e)) and under authority

delegated to the Director, Center for

Drug Evaluation and Research (21 CFR

5.82), approval of the applications listed

above, and all amendments and

supplements thereto, is hereby

withdrawn, effective March 31, 1995.

Dated: February 16, 1995.

Janet Woodcock,

Director, Center for Drug Evaluation and

Research.

[FR Doc. 95–5060 Filed 2–28–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95N–0050]

Drug Export; Sandostatin (Octreotide

Acetate) Lar Injection; 10-Milligram

(mg), 20-mg, and 30-mg Vials

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Sandoz Pharmaceuticals Corp. has

filed an application requesting

conditional approval for the export of

the human drug Sandostatin (octreotide

acetate) LAR Injection 10-mg, 20-mg,

and 30-mg vials to Switzerland for

further packaging and marketing.

ADDRESSES: Relevant information on

this application may be directed to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

rm. 1–23, 12420 Parklawn Dr.,

Rockville, MD 20857, and to the contact

person identified below. Any future

inquiries concerning the export of

human drugs under the Drug Export

Amendments Act of 1986 should also be

directed to the contact person.

FOR FURTHER INFORMATION CONTACT:

James E. Hamilton, Center for Drug

Evaluation and Research (HFD–310),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–594–2073.

SUPPLEMENTARY INFORMATION: The drug

export provisions in section 802 of the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 382) provide that

FDA may approve applications for the

export of drugs that are not currently

approved in the United States. Section

802(b)(3)(B) of the act sets forth the

requirements that must be met in an

application for approval. Section

802(b)(3)(C) of the act requires that the

agency review the application within 30

days of its filing to determine whether

the requirements of section 802(b)(3)(B)

have been satisfied. Section 802(b)(3)(A)

of the act requires that the agency

publish a notice in the Federal Register

within 10 days of the filing of an

application for export to facilitate public

participation in its review of the

application. To meet this requirement,

the agency is providing notice that

Sandoz Pharmaceuticals Corp., 59 Route

10, East Hanover, NJ 07936–1080, has

filed an application requesting approval

for the export of the human drug

Sandostatin (octreotide acetate) LAR

Injection 10-mg, 20-mg, and 30-mg vials

to Switzerland. This product is a new

formulation of octreotide acetate

manufactured by a different process

which is indicated for aromegaly,

malignant carcinoid syndrome, and

vipoma. The firm does have approval

for Sandostatin Injection. The