Federal Register / Vol. 62, No. 152 / Thursday, August 7, 1997 / Notices 42575

Mineral Density: Results from the PostMenopausal Estrogens/Progestins

Intervention (PEPI) Trial,’’ Journal of the

American Medical Association, Vol 276, No.

17, pp. 1389–1396, November 6, 1996.

97. Harris, S. T., H. K. Genant, D. J.

Baylink, et al., ‘‘The Effects of Estrone (Ogen)

on Spinal Bone Density of Postmenopausal

Women,’’ Archives of Internal Medicine,

151:1980–1984, October 1991.

98. United States Pharmacopeia 23,

‘‘Conjugated Estrogens Monograph,’’ p. 629,

1995.

99. Duursma, S. A., M. de Raadt, J. A.

Raymakers, and A. A. Haspels, ‘‘Is 1 mg of

Estradiol Valerate or 0.625 mg of Conjugated

Estrogens Sufficient for All Women to

Prevent Menopausal Bone Loss?’’

Gynecological Endocrinology., 6:205–209,

1992.

100. Transcript and Summary Minutes of

the meeting of FDA’s Fertility and Maternal

Health Drugs Advisory Committee, Vol. II,

pp. 85–105, July 27–28, 1995.

101. Lafferty, F. W., and M. E. Fiske,

‘‘Postmenopausal Estrogen Replacement: A

Long-Term Cohort Study,’’ American Journal

of Medicine, 97:66–77, 1994.

102. Bhavnani, B. R., ‘‘The Saga of the Ring

B Unsaturated Equine Estrogens,’’ Endocrine

Reviews, 9:396–416, 1988.

103. Wyeth-Ayerst submission to the

docket 94P–0429 (SUP 4), ‘‘Contributions of

>8,9-dehydroestrone (>8,9 DHES) to the

Biologic Activities of Conjugated Estrogens,’’

GTR–26521, pp. 38–40, September 25, 1995.,

104. Duramed submission to the docket

94P–0429 (C 94), January 8, 1997.

105. FDA, Center for Drug Evaluation and

Research, Office of Clinical Pharmacology

and Biopharmaceutics, Division of

Pharmaceutical Evaluation II, ‘‘A

Pharmacokinetic Analysis of Conjugated

Estrogens Including >8,9-Dehydroestrone

and 17>8,9-Dehydroestradiol,’’ October 25,

1996 (OCPB Report), Addendum 2, p. 26,

March 31, 1997.

106. Id., p. 8, Table 5.

V. Notice of Opportunity for a Hearing

The Director of CDER (the Director)

has evaluated the information discussed

above and, on the grounds stated, is

proposing to refuse to approve ANDA

40–115 and ANDA 40–154.

Therefore, notice is given to Duramed

and Barr and to all other interested

persons that under section 505

(j)(3)(C)(ii), (j)(3)(F), and (j)(3)(J) of the

act and § 314.127 (a)(3)(ii), (a)(6), and

(a)(12), the Director proposes to refuse

to approve ANDA 40–115 and ANDA

40–154.

In accordance with section

505(j)(4)(C) of the act and § 314.200(a),

the applicants are hereby given notice of

an opportunity for a hearing to show

that approval of ANDA 40–115 and

ANDA 40–154 should not be refused.

An applicant who decides to seek a

hearing shall file: (1) On or before

September 8, 1997: a written notice of

appearance and request for hearing, and

(2) on or before October 6, 1997, the

data, information, and analyses relied

on to demonstrate that there is a

genuine issue of material fact to justify

a hearing, as specified in § 314.200(c).

Any other interested person may also

submit comments on this notice. The

procedures and requirements governing

this notice of opportunity for a hearing,

a notice of appearance and request for

a hearing, information and analyses to

justify a hearing, other comments, and

a grant or denial of a hearing are

contained in § 314.200 and in 21 CFR

part 12.

The failure of the applicant to file a

timely written notice of appearance and

request for a hearing, as required by

§ 314.200, constitutes an election by that

person not to use the opportunity for a

hearing concerning the proposed action,

and a waiver of any contentions

concerning the legal status of the

referenced drug products.

A request for a hearing may not rest

upon mere allegations or denials, but

must present specific facts showing that

there is a genuine and substantial issue

of fact that requires a hearing. If it

conclusively appears from the face of

the data, information, and factual

analyses in the request for a hearing that

there is no genuine and substantial issue

of fact that precludes the refusal to

approve the application, or when a

request for a hearing is not made in the

required format or with the required

analyses, the Commissioner of Food and

Drugs will enter summary judgment

against the person who requests the

hearing, making findings and

conclusions, and denying a hearing.

All submissions pursuant to this

notice of opportunity for a hearing are

to be filed in four copies. Except for data

and information prohibited from public

disclosure under 21 U.S.C. 331(j) or 18

U.S.C. 1905, the submissions may be

seen in the Dockets Management Branch

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

p.m., Monday through Friday.

This notice is issued under the

Federal Food, Drug, and Cosmetic Act

(section 505) and under authority

delegated to the Director of the Center

for Drug Evaluation and Research (21

CFR 5.82).

Dated: July 29, 1997.

Murray M. Lumpkin,

Director, Center for Drug Evaluation and

Research.

[FR Doc. 97–20792 Filed 8–6–97; 8:45 am]

BILLING CODE 4160–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0326]

Sterling Drug, Inc., et al.; Withdrawal of

Approval of 28 New Drug Applications,

9 Abbreviated Antibiotic Applications,

and 46 Abbreviated New Drug

Applications

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is withdrawing

approval of 28 new drug applications

(NDA’s), 9 abbreviated antibiotic

applications (AADA’s), and 46

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: September 8, 1997.

FOR FURTHER INFORMATION CONTACT:

Olivia A. Vieira, 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.

Application No. Drug Applicant

NDA 6–801 Neocurtasal Sterling Drug, Inc., 90 Park Ave., New York, NY 10016.

NDA 8–472 Cyclaine Merck & Co., Inc., P.O. Box 4, BLA–20, West Point, PA

19486.

NDA 8–656 Hydrocortone Acetate Topical Ointment Do.
42576 Federal Register / Vol. 62, No. 152 / Thursday, August 7, 1997 / Notices

Application No. Drug Applicant

NDA 9–241 Serfia Tablets Westerfield Pharma, 3941 Brotherton Rd., Cincinnati, OH

45209.

NDA 9–272 Evraserp Tablets Evron Indust., 7475 North Rogers Ave., Chicago, IL 60626.

NDA 9–443 Rauwolfia Serpentina Tablets Direct Laboratories, 377 Genesse St., Buffalo, NY 14204.

NDA 9–459 Hexamethonium Chloride Tablets Global Pharms, 3725 Castor Ave., Philadelphia, PA 19124.

NDA 9–599 Sustac (Nitroglycerin) Extended-release Tablets, 2.6 milligrams (mg) and 6.5 mgKey Pharms, 909 Third Ave., New York, NY 10022–4731.

NDA 9–720 Reserpine Tablets S. F. Durst & Co., Inc., 1683 Winchester Rd., Philadelphia,

PA 19020.

NDA 9–765 Reserpine Tablets Hance Brothers & White Co., 12th & Hamilton Sts., Philadelphia, PA 19123.

NDA 9–812 Reserpine Tablets Boyle & Co., 6330 Chalet Dr., Los Angeles, CA 90022.

NDA 9–926 Rauserpin Tablets Ferndale Laboratories, Inc., 780 West Eight Mile Rd., Ferndale, MI 48220.

NDA 10–260 Ecolid Chloride Novartis Pharms, 556 Morris Ave., Summit, NJ 07901.

NDA 10–408 Ekans Tablets 100 mg Haag, Inc., 5 South 15th St., Richmond, VA 23219.

NDA 10–576 Perivas Tablets Grant Chemical Co., Inc., 924 Rogers Ave., Brooklyn, NY

11226.

NDA 10–581 Hyserpin Tablets Phys Products, 50 Washington St., Norwalk, CT 06856.

NDA 10–632 Serpena Tablets 0.25 mg (Reserpine) Haag, Inc.

NDA 10–751 Reserpine Tablets Horton & Converse Laboratories, Inc., 2200 South Figueroa

St., Los Angeles, CA 90007.

NDA 10–883 Serpanray Injection Panray, P.O. Box 150, Englewood, NJ 07631.

NDA 12–128 Fovane (benzthiazide) Tablets Pfizer, 235 East 42d St., New York, NY 10017–5755.

NDA 12–285 Syntocinon (oxytocin nasal solution) Nasal Spray Novartis Pharmaceutical Corp., 59 Rte. 10, East Hanover, NJ

07936–1080.

NDA 12–911 Metopirone (metyrapone USP) Tablets (only those portions of

NDA that deal with Tablets)

Novartis Pharms.

NDA 12–985 Duphaston (Dydrogesterone) Tablets, 5, 10, and 20 mg Solvay Pharmaceuticals, 901 Sawyer Rd., Marietta, GA

30062.

NDA 13–412 CUEMID Merck & Co., Inc.

NDA 13–538 Decaderm Do.

NDA 17–926 Regular Insulin (insulin injection, USP (Pork)) Novo Nordisk Pharmaceuticals, Inc., Suite 200, 100 Overlook

Center, Princeton, NJ 08540–7810.

NDA 17–929 NPH Insulin (isophane insulin suspension, USP (Beef)) Do.

NDA 17–998 Lente Insulin (insulin zinc suspension, USP (Beef)) Do.

AADA 60–633 Tetracycline Syrup, 125 mg/5 milliliters (mL) Alpharma, U.S. Pharmaceuticals Div., Suite 3500, 3333

Cassell Dr., Baltimore, MD 21224.

AADA 60–730 Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic

Solution, USP

Steris Laboratories, Inc., 620 North 51st Ave., Phoenix, AZ

85043–4705.

AADA 61–450 Oxacillin Sodium Capsules, USP Apothecon, Inc., P.O. Box 4500, Princeton, NJ 08543–4500.

AADA 62–300 Tetracycline Hydrochloride Capsules USP, 250 mg and 500

mg

Warner Chilcott, Inc., Rockaway 80 Corp. Center, 100 Enterprise Dr., Suite 280, Rockaway, NJ 07866.

AADA 62–521 Neomycin and Polymyxin B Sulfates and Hyrocortisone Otic

Suspension, USP

Steris Laboratories, Inc.

AADA 62–625 Ampicillin Trihydrate Non-Sterile Bulk SmithKline Beecham Pharmaceuticals, 1250 South

Collegeville Rd., P.O. Box 5089, Collegeville, PA 19426–

0989.

AADA 62–724 Cefadyl (Sterile Cephapirin Sodium, USP), ADD-Vantage vials Apothecon, Inc.

AADA 62–973 Cephalexin Capsules USP, 250 mg Do.

AADA 62–974 Cephalexin Capsules USP, 500 mg Do.

ANDA 70–042 Metronidazole Injection USP, 5 mg/mL Steris Laboratories, Inc.

ANDA 70–452 Methyldopa Tablets, USP, 500 mg Purepac Pharmaceutical Co., 200 Elmora Ave., Elizabeth, NJ

07207.

ANDA 70–749 Methyldopa Tablets, USP, 125 mg Do.

ANDA 70–750 Methyldopa Tablets, USP, 250 mg Do.

ANDA 70–912 Diazepam Injection USP, 5 mg/mL Steris Laboratories, Inc.

ANDA 71–122 Ibuprofen Tablets, USP, (200 mg, orange) Purepac Pharmaceutical Co.

ANDA 71–455 Pseudoephedrine Hydrochloride and Chlorpheniramine Maleate Extended-Release Capsules, 120 mg/12 mgKV Pharmaceutical Co., 2503 South Hanley Rd., St. Louis,

MO 63144–2555.

ANDA 71–656 Metaproterenol Sulfate Syrup USP, (10 mg/5 mL) Morton Grove Pharmaceuticals, Inc., 6451 West Main St.,

Morton Grove, IL 60053.

ANDA 71–664 Ibuprofen Tablets, USP, (200 mg, white) Purepac Pharmaceutical Co.

ANDA 71–964 Ibuprofen Tablets, USP, 800 mg Do.

ANDA 72–758 Triprolidine and Pseudoephedrine Hydrochlorides ExtendedRelease Caplets, 5 mg/120 mgKV Pharmaceutical Co.

ANDA 80–325 Prednisolone Tablets, 5 mg Purepac Pharmaceutical Co.

ANDA 80–753 Reserpine Tablets USP, 0.1 mg and 0.25 mg Do.

ANDA 83–013 Cyanocobalamin Injection USP, 100 micrograms (μg)/mL Steris Laboratories, Inc.

ANDA 83–064 Cyanocobalamin Injection USP, 1,000 μg/mL Do.

ANDA 83–120 Cyanocobalamin Injection USP, 100 μg/mL and 1,000 μg/mL Do.

ANDA 83–532 Promethazine Hydrochloride Injection USP, 50 mg/mL Do.
Federal Register / Vol. 62, No. 152 / Thursday, August 7, 1997 / Notices 42577

Application No. Drug Applicant

ANDA 83–533 Diphenhydramine Hydrochloride Injection USP, 10 mg/mL Do.

ANDA 83–534 Thiamine Hydrochloride Injection USP, 100 mg/mL and 200

mg/mL

Do.

ANDA 83–535 Procaine Hydrochloride Injection USP, 1% and 2% Do.

ANDA 83–595 Testosterone Propionate Injection USP, 100 mg/mL Do.

ANDA 83–627 Lidocaine Hydrochloride Injection USP, 1% and 2% Do.

ANDA 83–654 Sterile Prednisolone Acetate Suspension USP, 25 mg/mL Do.

ANDA 83–667 Testosterone Enanthate Injection USP, 100 mg/mL and 200

mg/mL

Do.

ANDA 83–759 Sterile Hydrocortisone Acetate Sterile Suspension USP, 25

mg/mL and 50 mg/mL

Do.

ANDA 83–760 Pyridoxine Hydrochloride Injection USP, 100 mg/mL Do.

ANDA 84–355 Dexamethasone Sodium Phosphate Injection USP, 4 mg/mL

(base)

Do.

ANDA 84–401 Testosterone Cypionate Injection USP, 100 mg/mL and 200

mg/mL

Do.

ANDA 84–740 Phendimetrazine Tartrate Tablets, 35 mg (Gray) Inwood Laboratories, Inc., 909 Third Ave., New York, NY

10022–4731.

ANDA 84–741 Phendimetrazine Tartrate Tablets, 35 mg (Yellow) Do.

ANDA 84–742 Phendimetrazine Tartrate Tablets, 35 mg (Pink) Do.

ANDA 84–743 Phendimetrazine Tartrate Tablets, 35 mg (Green) Do.

ANDA 85–374 Sterile Methylprednisolone Acetate Sterile Suspension USP,

40 mg/mL

Steris Laboratories, Inc.

ANDA 85–463 Lidocaine Hydrochloride and Epinephrine Injection USP 1%;

0.01 mg/mL

Do.

ANDA 85–528 Hydroxocobalamin Injection USP, 1,000 μg/mL Do.

ANDA 85–529 Sterile Triamcinolone Diacetate Suspension USP, 40 mg/mL Do.

ANDA 85–781 Sterile Prednisolone Acetate Suspension USP, 50 mg/mL Do.

ANDA 86–052 Hydrocortisone Acetate Cream, 1% Purepac Pharmaceutical Co.

ANDA 86–507 Sterile Methylprednisolone Acetate Suspension USP, 80 mg/

mL

Steris Laboratories, Inc.

ANDA 87–192 Triamcinolone Acetonide Lotion USP, 1% Alpharma, U.S. Pharmaceuticals Div.

ANDA 87–214 Phendimetrazine (Extended-release Capsules, 105 mg) D. M. Graham Laboratories, Inc., 58 Pearl St., P.O. Box P,

Hobart, NY 13788.

ANDA 87–248 Sterile Methylprednisolone Acetate Suspension USP, 20 mg/

mL

Steris Laboratories, Inc.

ANDA 87–598 Nandrolone Decanoate Injection USP, 50 mg/mL Do.

ANDA 87–599 Nandrolone Decanoate Injection USP, 100 mg/mL Do.

ANDA 88–062 Hyrex-105 (Phendimetrazine Tartrate Extended-release Capsules, 105 mg)D. M. Graham Laboratories, Inc.

ANDA 88–305 Axotal Tablets (Butalbital and Aspirin Tablets USP) 50 mg/

650 mg

Savage Laboratories, 60 Baylis Rd., Melville, NY 11747.

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

September 8, 1997.

Dated: July 17, 1997.

Janet Woodcock,

Director, Center for Drug Evaluation and

Research.

[FR Doc. 97–20871 Filed 8–6–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

Periodically, the Health Resources

and Services Administration (HRSA)

publishes abstracts of information

collection requests under review by the

Office of Management and Budget, in

compliance with the Paperwork

Reduction Act of 1995 (44 U.S.C.

Chapter 35). To request a copy of the

clearance requests submitted to OMB for

review, call the HRSA Reports

Clearance Office on (301)–443–1129.

The following request has been

submitted to the Office of Management

and Budget for review under the

Paperwork Reduction Act of 1995:

Grantee Reporting Requirements for the

Rural Health Network Grant Program—

New—

The Rural Health Network Grant

Program is authorized by Section 330A

of the Public Health Service Act as

amended by the Health Centers

Consolidation Act of 1996 (Public Law

104–229). The purpose of the program is

to assist in the development of vertically

integrated networks of health care

providers in rural communities.

Grantees will be working to change the

delivery system in their service areas

and will be using the federal funds to

develop network capabilities.

Grantees will be asked to submit a

baseline report and semiannual tracking

reports which provide information on

progress towards goals and objectives of

the network, progress toward

developing the governance and

organizational arrangements for the

network, specific network activities,