Federal Register / Vol. 65, No. 191 / Monday, October 2, 2000 / Notices 58775

Dated: September 26, 2000.

Nancy Cheal,

Acting Associate Director for Policy,

Planning, and Evaluation, Centers for Disease

Control and Prevention (CDC).

[FR Doc. 00–25144 Filed 9–29–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Statement of Organization, Functions,

and Delegations of Authority

Part C (Centers for Disease Control

and Prevention) of the Statement of

Organization, Functions, and

Delegations of Authority of the

Department of Health and Human

Services (45 FR 67772–76, dated

October 14, 1980, and corrected at 45 FR

69296, October 20, 1980, as amended

most recently at 65 FR 41079, dated July

3, 2000) is amended to reflect the

retitling of the Division of Public Health

Systems and the Division of Media and

Training Services, Public Health

Practice Program Office, to the Division

of Public Health Systems Development

and Research and the Division of

Professional Development and

Evaluation respectively.

Section C–B, Organization and

Functions, is hereby amended as

follows:

Delete the title Division of Public

Health Systems (CH5) and insert the

title Division of Public Health Systems

Development and Research (CH5).

Delete the title Division of Media and

Training Services (CH7) and insert the

title Division of Professional

Development and Evaluation (CH7).

Dated: September 20, 2000.

Martha Katz,

Acting Director.

[FR Doc. 00–25261 Filed 9–29–00; 8:45 am]

BILLING CODE 4160–18–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1516]

Apothecon, Inc., et al.; Withdrawal of

Approval of 76 Abbreviated New Drug

Applications

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is withdrawing

approval of 76 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withdrawn.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: October 10, 2000.

FOR FURTHER INFORMATION CONTACT:

Olivia A. Pritzlaff, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

2041.

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.

ANDA No. Drug Applicant

60–100 Crysticillin (Penicillin G Procaine Suspension

USP).

Apothecon, Inc., P.O. Box 4500, Princeton, NJ 08543.

60–618 Grifulvin V (Griseofluvin Microsize) Tablets, 125

milligrams (mg), 250 mg, and 500 mg.

Johnson & Johnson Consumer Co, Inc., 199 Grandview Rd.,

Skillman, NJ 08858.

61–220 Opthochlor (Chloramphenicol Ophthalmic Solution

USP) 5 mg/milliliter (mL).

Parkedale Pharmaceuticals, Inc., 501 Fifth St., Bristol, TN 37620.

61–334 Bactocill (Oxacillin Sodium for Injection). SmithKline Beecham Pharmaceuticals, One Franklin Plaza, P.O.

Box 7929, Philadelphia, PA 19101.

61–449 Staphcillin (Methicillin Sodium). Apothecon, Inc.

61–452 Cloxacillin Sodium Capsules USP, 250 mg and

500 mg.

Do.

61–739 Garamycin Pediatric Injection (Gentamicin Sulfate

Injection USP).

Schering Corp., 2000 Galloping Hill Rd., Kenilworth, NJ 07033.

62–328 Erythromycin Topical Solution USP, 1.5%. Alpharma, 333 Cassell Dr., suite 3500, Baltimore, MD 21224.

62–727 Totacillin-N (Ampicillin Sodium) for Injection. Smithkline Beecham Pharmaceuticals.

62–755 Nallpen (Nafcillin Sodium Powder for Injection

USP).

Do.

70–356 Diazepam Tablets USP, 2 mg. Roxane Laboratories, Inc., P.O. Box 16532, Columbus, OH 43216.

70–357 Diazepam Tablets USP, 5 mg. Do.

70–358 Diazepam Tablets USP, 10 mg. Do.

71–010 Acetominophen Suppositories, 120 mg. Do.

71–011 Acetominophen Suppositories, 650 mg. Do.

71–018 Metaproterenol Sulfate Inhalation Solution USP,

0.6%.

AstraZeneca, L.P.

71–275 Metaproterenol Sulfate Inhalation Solution USP,

0.4%.

Do.

72–018 Droperidol Injection USP, 2.5 mg/mL. Do.

72–019 Droperidol Injection USP, 2.5 mg/mL. Do.

72–021 Droperidol Injection USP, 2.5 mg/mL. Do.

72–648 Timolol Maleate Tablets USP, 5 mg. Novopharm Limited, c/o Novopharm NC, Inc., 4700 Novopharm

Blvd., Wilson, NC 27893.

72–649 Timolol Maleate Tablets USP, 10 mg. Do.

72–650 Timolol Maleate Tablets USP, 20 mg. Do.

58776 Federal Register / Vol. 65, No. 191 / Monday, October 2, 2000 / Notices

ANDA No. Drug Applicant

73–187 Loperamide Hydrochloride Oral Solution, 1 mg/5

mL.

Alpharma.

73–340 Prometa Inhalation Solution (Metaproternol Sulfate

Inhalation Solution USP), 5%.

Muro Pharmaceutical, Inc., 890 East St., Tewksbury, MA 01876.

74–361 Cimetidine Tablets USP, 300 mg, 400 mg, and

800 mg.

Roxane Laboratories, Inc.

74–371 Cimetidine Tablets USP, 800 mg. Do.

74–790 Ketorolac Tromethamine Tablets USP. Do.

74–832 Captopril and Hydrochlorothiazide Tablets USP, 50

mg/25 mg.

Danbury Pharmacal, Inc., 131 West St., Danbury, CT 06810.

80–001 Calcium Gluceptate Injection USP. Abbott Laboratories.

80–327 Prednisolone Tablets USP, 5 mg. Roxane Laboratories, Inc.

80–474 Hytone (Hydrocortisone) Ointment 0.25%, 0.5%,

1%, and 2.5%.

Dermik Laboratories, Inc., 500 Arcola Rd., P.O. Box 1200,

Collegeville, PA 19426–0107.

83–682 Phendimetrazine Tartrate Tablets USP, 35 mg. Zenith Goldline Pharmaceuticals, Inc., 140 Legerand Ave.,

Northvale, NJ 07647.

84–655 Prednicen-M (Prednisone Tablets USP), 5 mg. Schwarz Pharma, Inc., P.O. Box 2038, Milwaukee, WI 53201.

84–659 Acetominophen and Codeine Phosphate Tablets

USP, 300 mg/15 mg.

Roxane Laboratories, Inc.

84–667 Acetominophen and Codeine Phosphate Tablets

USP, 300 mg/60 mg.

Do.

84–811 Apresazide (Hydralazine Hydrochloride and

Hydrochlorothiazide USP) Capsules, 100/50 mg.

Novartis Pharmaceuticals Corp.

84–990 Dexone (Dexamethasone Tablets, USP), 1.5 mg. Solvay Pharmaceuticals, Inc., 901 Sawyer Rd., Marietta, GA 30062.

85–539 Flutex (Triamcinolone Acetonide Cream USP),

0.1%, 0.5%, and 0.025%.

Zenith Goldline Pharmaceuticals, Inc.

85–686 Curretab (Medroxyprogesterone Acetate Tablets,

USP) 10 mg.

Solvay Pharmaceuticals, Inc.

85–733 Hydrocortisone Cream USP, 1%. Zenith Goldline Pharmaceuticals, Inc.

85–777 Selenium Sulfide Lotion USP, 2.5%. Do.

85–873 Butabarbital Sodium Elixir, 30 mg/5 mL. Alpharma.

85–944 Amitriptyline Hydrochloride Tablets USP, 25 mg. Roxane Laboratories, Inc.

85–945 Amitriptyline Hydrochloride Tablets USP, 50 mg. Do.

86–002 Amitriptyline Hydrochloride Tablets USP, 10 mg. Do.

86–003 Amitriptyline Hydrochloride Tablets USP, 100 mg. Do.

86–004 Amitriptyline Hydrochloride Tablets USP, 75 mg. Do.

86–065 Procan SR (Procainamide Hydrochloride

Extended-Release Tablets, USP), 500 mg.

Parkedale Pharmaceuticals, Inc.

86–090 Amitriptyline Hydrochloride Tablets USP, 150 mg. Roxane Laboratories, Inc.

87–025 Isoetharine Inhalation Solution USP, 0.125%. Roxane Laboratories, Inc.

87–203 Flurandrenolide Lotion USP. Alpharma.

87–328 Trifluoperazine Hydrocholride Tablets USP, 5 mg. Zenith Goldline Pharmaceuticals, Inc.

87–375 Flutex (Triamcinolone Acetonide Ointment USP). Do.

87–376 Flutex (Triamcinolone Acetonide Ointment USP). Do.

87–377 Flutex (Triamcinolone Acetonide Ointment USP). Do.

87–396 Isoetharine Inhalation Solution USP, 0.1%. Roxane Laboratories, Inc.

87–427 Nogenic HC (Hydrocortisone Cream USP), 1%. Zenith Goldline Pharmaceuticals, Inc.

87–428 Triatex (Triamcinolone Acetonide Cream USP),

0.5%.

Do.

87–429 Triatex (Triamcinolone Acetonide Cream USP),

0.1%.

Do.

87–430 Triatex (Triamcinolone Acetonide Cream USP),

0.025%.

Do.

87–510 Procan SR (Procainamide Hydrochloride

Extended-Release Tablets, USP), 750 mg.

Parkedale Pharmaceuticals, Inc.

87–611 Liquid Pred (Prednisone Syrup USP), 5 mg/5 mL. Muro Pharmaceutical, Inc.

87–612 Trifluoperazine Hydrochloride Tablets USP, 1 mg. Zenith Goldline Pharmaceuticals, Inc.

87–613 Trifluoperazine Hydrochloride Tablets USP, 2 mg. Do.

87–614 Trifluoperazine Hydrochloride Tablets USP, 10 mg. Do.

87–742 Oxycodone Hydrochloride 2.25 mg, Oxycodone

Terephthalate 0.19 mg, and Aspirin 325 mg

Tablets.

Roxane Laboratories, Inc.

88–275 Isoetharine Inhalation Solution USP, 0.25%. Do.

88–489 Procan SR (Procainamide Hydrochloride

Extended-Release Tablets, USP), 1 gram.

Parkedale Pharmaceuticals, Inc.

89–193 Methocarbamol and Aspirin Coated Tablets, 400

mg/325 mg.

McNeil Consumer Healthcare, 7050 Camp Hill Rd., Fort Washington, PA 19034–2299.

89–427 Dipyridamole Tablets USP, 75 mg. Purepac Pharmaceutical Co., 200 Elmora Ave., Elizabeth, NJ

07207.

89–614 Isoetharine Inhalation Solution USP, 0.062%. AstraZeneca, L.P.

89–615 Isoetharine Inhalation Solution USP, 0.125%. Do.

Federal Register / Vol. 65, No. 191 / Monday, October 2, 2000 / Notices 58777

ANDA No. Drug Applicant

89–616 Isoetharine Inhalation Solution USP, 0.167%. Do.

89–617 Isoetharine Inhalation Solution USP, 0.2%. Do.

89–618 Isoetharine Inhalation Solution USP, 0.25%. Do.

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

in the table in this document, and all

amendments and supplements thereto,

is hereby withdrawn, effective October

10, 2000.

Dated: September 12, 2000.

Janet Woodcock,

Director, Center for Drug Evaluation and

Research.

[FR Doc. 00–24844 Filed 9–29–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Government-Owned Inventions;

Availability for Licensing

AGENCY: National Institutes of Health,

Public Health Service, DHHS.

ACTION: Notice.

SUMMARY: The inventions listed below

are owned by agencies of the U.S.

Government and are available for

licensing in the U.S. in accordance with

35 U.S.C. 207 to achieve expeditious

commercialization of results of

federally-funded research and

development. Foreign patent

applications are filed on selected

inventions to extend market coverage

for companies and may also be available

for licensing.

ADDRESSES: Licensing information and

copies of the U.S. patent applications

listed below may be obtained by writing

to the indicated licensing contact at the

Office of Technology Transfer, National

Institutes of Health, 6011 Executive

Boulevard, Suite 325, Rockville,

Maryland 20852–3804; telephone: 301/

496–7057; fax: 301/402–0220. A signed

Confidential Disclosure Agreement will

be required to receive copies of the

patent applications.

Method and Device for Analysis of

Biological Specimens

M. Emmert-Buck (NCI), C. Englert (NCI),

R. Bonner (NICHD), and L. Liotta

(NCI)

DHHS Reference No. E–197–00/0 filed

26 Jul 2000

Licensing Contact: Uri Reichman; 301/

496–7736 ext. 240; e-mail:

reichmau@od.nih.gov

The invention discloses methods for

selective analysis of cellular samples,

and more particularly it provides

methods for selective analysis of tissue

samples, such as tumors. The methods

include placing the tissue on a surface

such as membrane for example, and

activating the surface at selected sites

adjacent to the cells of interest. The

activated sites become permeable and

thus transferable to fluids. The cells

adjacent to the permeable sites can than

be selectively extracted and their

content analyzed by standard

biochemical procedures or by applying

the extract to microarray devices, such

as cDNA arrays, for analysis of gene

expression etc. The technique presents

a convenient alternative to existing

methods of tissue microdissection. For

further convenience, the technique can

be readily combined with a variety of

analytical devices such as microarrays

biochips or other devices which include

multiple regions carrying multiple

capture molecules.

Hepatitis A Virus Clones Adapted for

Growth in African Green Monkey

Kidney (AGMK) Cells and Vaccines

Comprising said Clones

Robert H. Purcell et al. (NIAID)

DHHS Reference No. E–008–95/0 filed

06 Aug 1999

Licensing Specialist: Carol Salata; 301/

496–7735 ext. 232; e-mail:

salatac@od.nih.gov

The present invention relates to

hepatitis A virus clones adapted to

growth in African Green Monkey

Kidney Cells intended to be used as a

live attenuated vaccine. Several cell

culture-adapted strains of hepatitis A

virus (HAV) are currently being used as

inactivated vaccines. However, the

inactivated vaccines have the limitation

that multiple doses are required for

effective immunization. Thus, a live

vaccine could have the advantage of

inducing life-long immunity following

administration of only a single dose.

Preclinical studies have been done

using virus isolates of this invention.

Preliminary observations suggest that

some of the HM–175 P39 virus isolates

analyzed may be promising candidates

for use as a live attenuated vaccine.

HM–175 P39 clone 15 appears to have

the growth and attenuation properties

that are desirable in a live vaccine for

HAV as it is partially attenuated for

tamarins and fully attenuated for

chimpanzees. HM–175 P39 clone 13

may also be a potential vaccine

candidate as it replicates efficiently in

tamarins, resulting in moderate

increases in serum liver enzyme and

early seroconversion to anti-HAV

positivity but is still fully attenuated for

chimpanzees.

Method of Predicting Susceptibility to

HIV Infection or Progression of HIV

Disease

Michael W. Smith, Hyoung Doo Shin,

Stephen J. O’Brien (NCI)

DHHS Reference No. E–066–99/0 filed

09 Apr 1999 and DHHS Reference No.

E–066–99/1 filed 06 Apr 2000

Licensing Contact: J. P. Kim; 301/496–

7056 ext. 264; e-mail:

kimj@od.nih.gov

This invention identifies the

importance of a variant in the IL 10 gene

(–592–5′A) that is commonly found in

the population with HIV–1/AIDS.

Individuals that inherit one or two

copies of this form of IL 10 are at a

greater risk for progression from HIV–1

infection to the development of clinical

AIDS or death. The effects of IL 10–592

are particularly evident 5 years after

infection. The gene variant and its

product may be of diagnostic value in

testing to determine treatment regimens

for patients and mimicking the effect of

the IL 10–5′A gene variant may be

useful in developing therapies for HIV

infection. The polymorphism of the

present invention can be used in

association with other alleles, such as

CCR5–D32, CCR2–64I, CCR5– +.P1.+,

HLA–B35 and HLA homozygosity, to

determine an individual’s susceptibility

to HIV infection, and provide a

prognosis for disease progression in

those who have been infected. The

potential therapies derived from the IL

10–592 genetic variant may be

particularly applicable to patients on

triple drug therapy since these patients

have generally been infected for a

number of years prior to treatment.