Federal Register / Vol. 62, No. 186 / Thursday, September 25, 1997 / Notices 50387

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97F–0388]

Cultor Food Science, Inc.; Filing of

Food Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Cultor Food Science, Inc., has filed

a petition proposing that the food

additive regulations be amended to

permit aqueous transition metal

catalytic hydrogenation in the

production of polydextrose and to adopt

the specifications for polydextrose of

the Food Chemicals Codex, 4th ed.,

1996.

DATES: Written comments on the

petitioner’s environmental assessment

by October 27, 1997.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Rosalie M. Angeles, Center for Food

Safety and Applied Nutrition (HFS–

206), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–418–3107.

SUPPLEMENTARY INFORMATION: Under the

Federal Food, Drug, and Cosmetic Act

(sec. 409(b)(5) (21 U.S.C. 348(b)(5))),

notice is given that a food additive

petition (FAP 7A4556) has been filed by

Cultor Food Science, Inc., 205 East 42d

St., New York, NY 10017. The petition

proposes to amend the food additive

regulations in § 172.841 Polydextrose

(21 CFR 172.841) to permit aqueous

transition metal catalytic hydrogenation

in the production of polydextrose and to

adopt the specifications for

polydextrose of the Food Chemicals

Codex, 4th ed., 1996, pp. 297–300.

The potential environmental impact

of this action is being reviewed. To

encourage public participation

consistent with regulations promulgated

under the National Environmental

Policy Act (40 CFR 1501.4(b)), the

agency is placing the environmental

assessment submitted with the petition

that is the subject of this notice on

public display at the Dockets

Management Branch (address above) for

public review and comment. Interested

persons may, on or before October 27,

1997 submit to the Dockets Management

Branch (address above) written

comments. 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 office

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

Monday through Friday. FDA will also

place on public display any

amendments to, or comments on, the

petitioner’s environmental assessment

without further announcement in the

Federal Register. If, based on its review,

the agency finds that an environmental

impact statement is not required and

this petition results in a regulation, the

notice of availability of the agency’s

finding of no significant impact and the

evidence supporting that finding will be

published with the regulation in the

Federal Register in accordance with 21

CFR 25.40(c).

Dated: September 9, 1997.

Alan M. Rulis,

Director, Office of Premarket Approval,

Center for Food Safety and Applied Nutrition.

[FR Doc. 97–25368 Filed 9–24–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food And Drug Administration

[Docket No. 97F–0405]

Shikoku Chemical Corp.; Filing of

Food Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Shikoku Chemical Corp. has filed a

petition proposing that the food additive

regulations be amended to provide for

the safe use of aluminum borate as an

antistatic agent and/or antifogging agent

for olefin polymers intended for use as

packaging materials in contact with

food.

FOR FURTHER INFORMATION CONTACT: Vir

D. Anand, Center for Food Safety and

Applied Nutrition (HFS–215), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3081.

SUPPLEMENTARY INFORMATION: Under the

Federal Food, Drug, and Cosmetic Act

(sec. 409(b)(5) (21 U.S.C. 348(b)(5))),

notice is given that a food additive

petition (FAP 7B4559) has been filed by

Shikoku Chemical Corp., c/o SRS

International Corp., suite 1000, 1625 K

St. NW., Washington DC 20006–1604.

The petition proposes to amend the food

additive regulations in § 178.3130

Antistatic and/or antifogging agents in

food-packaging materials (21 CFR

178.3130) to provide for the safe use of

aluminum borate as an antistatic and/or

antifogging agent for olefin polymers

complying with 21 CFR 177.1520(c) as

packaging materials intended for use in

contact with food.

The agency has determined under 21

CFR 25.32(i) that this action is of the

type that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

Dated: September 11, 1997.

Alan M. Rulis,

Director, Office of Premarket Approval,

Center for Food Safety and Applied Nutrition.

[FR Doc. 97–25430 Filed 9–24–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0399]

Helen A. Ballack Co. et al.; Withdrawal

of Approval of 61 New Drug

Applications, 8 Abbreviated Antibiotic

Applications, and 36 Abbreviated New

Drug Applications

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is withdrawing

approval of 61 new drug applications

(NDA’s), 8 abbreviated antibiotic

applications (AADA’s), and 36

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 25, 1997.

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,
50388 Federal Register / Vol. 62, No. 186 / Thursday, September 25, 1997 / Notices

by their request, waived their

opportunity for a hearing.

Application No. Drug Applicant

NDA 4–526 Bal-Con Capsules Helen A. Ballack Co., 1356 Book Bldg., Detroit, MI 48226.

NDA 6–203 Nupercaine Heavy Solution (dibucaine hydrochloride) Novartis Pharmaceuticals Corp., 59 Rt. 10, East Hanover, NJ

07936–1080.

NDA 6–514 Benylin (diphenhydramine hydrochloride) Cough Syrup 12.5

milligrams (mg)/milliliter (mL)

Warner-Lambert Co., 170 Tabor Rd., Morris Plains, NJ 07950.

NDA 6–550 ORTHOXICOL Cough Syrup The Upjohn Co., 7000 Portage Rd., Kalamazoo, MI 49001–

0199.

NDA 6–658 Floropryl (isoflurophate ophthalmic solution) Ophthalmic SolutionMerck & Co., Inc., P.O. Box 4, BLA–20, West Point, PA

19486.

NDA 6–921 CHLOR-TRIMETON (chlorpheniramine maleate) Tablets and

Syrup

Schering-Plough Corp., 2000 Galloping Hill Rd., Kenilworth,

NJ 07033.

NDA 7–635 NPH Insulin Merck Sharp & Dohme, Division of Merck & Co., Inc.

NDA 7–757 Gantrisin (sulfoxazole diolamine ophthalmic solution) Ophthalmic SolutionHoffman-LaRoche, Inc., 340 Kingsland St., Nutley, NJ 07110–

1199.

NDA 9–018 Hydrocortone Acetate Ophthalmic Solution and Ophthalmic

Ointment

Merck & Co., Inc.

NDA 10–656 Floropryl (isoflurophate ophthalmic ointment) Ophthalmic OintmentDo.

NDA 11–185 Reserpine Tablets USP, 0.1 mg and 0.25 mg Zenith Goldline Pharmaceuticals, Inc., 140 Legrand Ave.,

Northvale, NJ 07647.

NDA 11–300 Paraflex (chlorzoxazone tablet) Caplets, 250 mg R. W. Johnson Pharmaceutical Research Institute, 920 Rt.

202 South, P.O. Box 300, Raritan, NJ 08860–0602.

NDA 11–521 Rauwolfia Serpentine Tablets USP, 50 mg and 100 mg Zenith Goldline Pharmaceuticals, Inc.

NDA 11–919 Otrivin (xylometazoline hydrochloride) Novartis Pharmaceuticals, Corp., 59 Rt. 10, East Hanover, NJ

07936–1080.

NDA 17–313 Iodohippurate Sodium I–131 Injection CIS–US, Inc., 10 De Angelo Dr., Bedford, MA 01730.

NDA 17–672 Lithonate Syrup (Lithium Citrate Syrup, USP) Solvay Pharmaceuticals, Inc., 901 Sawyer Rd., Marietta, GA

30062.

NDA 17–792 AN–MAA, Technetium TC 99m Albumin Aggregated Kit CIS–US, Inc.

NDA 17–996 Semilente Insulin (prompt insulin zinc suspension, USP

(Beef))

Novo Nordisk Pharmaceuticals, Inc., suite 200, 100 Overlook

Center, Princeton, NJ 08540–7810.

NDA 17–997 Ultralente Insulin (extended insulin zinc suspension, USP

(Beef))

Novo Nordisk.

NDA 18–125 Halog (halcinonide ointment) Ointment, 0.025% Bristol-Myers Squibb Pharmaceutical Research Institute, P.O.

Box 4000, Princeton, NJ 08543–4000.

NDA 18–055 3.3% Dextrose and 0.3% Sodium Chloride Injection in Flexible

Containers

Abbott Laboratories, D–389 Bldg. AP30, 200 Abbott Park Rd.,

Abbott Park, IL 60064–3537.

NDA 18–384 Lentard (Purified pork and beef insulin zinc suspension) Novo Nordisk.

NDA 18–462 Ringer’s Irrigation in Flexible Containers Abbott Laboratories.

NDA 18–525 Purified beef insulin zinc suspension Novo Nordisk.

NDA 18–526 Isophane purified beef insulin suspension Do.

NDA 18–528 Purified pork insulin injection Do.

NDA 18–804 Aminosyn 3.5% and 3.5%M in Flexible Containers Abbott Laboratories.

NDA 18–875 Aminosyn 3.5% and 3.5%M in CR3 Flexible Containers Do.

NDA 18–923 38.5% Dextrose Injection in Flexible Containers Do.

NDA 19–065 Novolin N NPH Human Insulin Isophane Suspension (semisynthetic)Novo Nordisk.

NDA 19–118 Aminosyn 3.5% and 25% Dextrose Injection Abbott Laboratories.

NDA 19–119 Aminosyn 4.25% and 25% Dextrose Injection Do.

NDA 19–120 Aminosyn 3.5% and 5% Dextrose Injection Do.

NDA 19–218 0.9% Sodium Chloride Injection in Plastic Vials Do.

NDA 19–339 Heparin Sodium in 5% Dextrose Injection in CR3 Flexible

Container

Do.

NDA 19–400 Aminosyn-HBC 7% in CR3 Flexible Containers Do.

NDA 19–449 Insulatard NPH Human (human insulin (semi-synthetic)

isophane suspension)

Novo Nordisk.

NDA 19–482 5% Dextrose and 0.225% Sodium Chloride Injection in 250

mL ADD-Vantage Flexible Containers

Abbott Laboratories.

NDA 19–483 5% Dextrose and 0.9% Sodium Chloride Injection in 250 mL

ADD-Vantage Flexible Containers

Do.

NDA 19–484 5% Dextrose and 0.45% Sodium Chloride Injection in 250 mL

ADD-Vantage Flexible Containers

Do.

NDA 19–485 Lactated Ringer’s Injection in 250 mL ADD-Vantage Flexible

Containers

Do.

NDA 19–486 5% Dextrose and 0.3% Sodium Chloride Injection in 250 mL

ADD-Vantage Flexible Containers

Do.

NDA 19–491 Aminosyn II 3.5% in CR3 Flexible Containers Do.

NDA 19–493 Aminosyn II 3.5M in CR3 Flexible Containers Do.
Federal Register / Vol. 62, No. 186 / Thursday, September 25, 1997 / Notices 50389

Application No. Drug Applicant

NDA 19–504 Aminosyn II 4.25% w/25% Dextrose in Dual-Chamber Flexible

Container

Do.

NDA 19–505 Aminosyn II 3.5% w/25% Dextrose in CR3 Dual-Chamber

Flexible Container

Do.

NDA 19–506 Aminosyn II 3.5% w/5% Dextrose in CR3 Dual-Chamber

Flexible Container

Do.

NDA 19–712 Aminosyn II w/Electrolytes in Dextrose Injection in 2000 mL

CR3 Flexible Container

Do.

NDA 19–713 Aminosyn II in Dextrose Injection in CR3 Flexible Containers Do.

NDA 19–714 Aminosyn II w/Electrolytes in Dextrose Injection w/Calcium in

2000 mL CR3 Flexible Container

Do.

NDA 19–837 Bretylium Tosylate in 5% Dextrose Injection in Plastic Container, PL 146Baxter Healthcare Corp., Rt. 120 and Wilson Rd., Round

Lake, IL 60073–0490.

NDA 20–043 OMNIFLOX (temafloxacin hydrochloride) Filmtab Tablets Abbott Laboratories.

NDA 50–188 VINACTANE (sterile viomycin sulfate) Novartis Pharms, 556 Morris Ave., Summit, NJ 07901.

NDA 50–019 Penbritin Drops Wyeth-Ayerst Laboratories, P.O. Box 8299, Philadelphia, PA

19101–8299.

NDA 50–028 DYNAPEN (Dicloxacillin sodium menohydrate) Capsules Bristol-Myers, U.S. Pharmaceutical Group, Evansville, IN

47721–0001.

NDA 50–029 Hetacillin Potassium, Sterile Bristol-Myers Squibb Co., P.O. Box 4755, Syracuse, NY

13221–4755.

NDA 50–134 SYNCILLIN (phenethicillin potassium) O.S. Bristol-Myers, U.S. Pharmaceutical Group.

NDA 50–328 Methicillin Sodium Bristol-Myers Squibb Co.

NDA 50–378 Neohydeltrasol (neomycin sulfate/prednisolone sodium sulfate

ophthalmic ointment) Ophthalmic Ointment

Merck & Co., Inc.

NDA 50–562 Azlin (azlocillin sodium) Miles, Pharmaceutical Division, 400 Morgan Lane, West

Haven, CT 06516–4175.

NDA 50–618 AMIKIN (amikacin sulfate) in 0.9% NaCL (PVC flexible containers)Apothecon, P.O. Box 4500, Princeton, NJ 08543–4500.

AADA 60–291 Tetracycline Oral Suspension USP, 125 mg/5 mL Purepac Pharmaceutical Co., 200 Elmora Ave., Elizabeth, NJ

07207.

AADA 62–218 Ampicillin Trihydrate, bulk drug ACS Dobfar SpA, U.S. Agent: Interchem Corp., 120 Rt. 17

North, P.O. Box 1579, Paramus, NJ 07653–1579.

AADA 62–319 Tetracycline Hydrochloride (bulk, nonsterile) Tianjin Pharmaceuticals Corp., U.S. Agent: Darsheng Trade &

Tech. Dev. Co., Ltd., P.O. Box 1220, 655 Amboy Ave., Awing, 1st Fl., Woodbridge, NJ 07095.

AADA 62–387 Nystatin Cream USP, 100,000 Units/g Alpharma, U.S. Pharmaceuticals Div., Johns Hopkins Bayview

Center, 333 Cassell Dr., suite 3500, Baltimore, MD 21224.

AADA 62–571 Nystatin Oral Suspension USP, 100,000 Units/mL Do.

AADA 62–731 Nystatin Ointment USP, 100,000 Units/g Do.

AADA 62–809 Cephalexin Capsules USP, 250 mg and 500 mg Purepac Pharmaceutical.

AADA 62–942 Cyclacilin, bulk drug ACS Dobfar SpA.

ANDA 70–580 Allopurinol Tablets, USP, 300 mg Purepac Pharmaceutical.

ANDA 71–085 Betamethasone Dipropionate Lotion USP, 0.05% Alpharma.

ANDA 71–798 Triprolidine and Pseudo-ephedrine Hydrochlorides ExtendedRelease Capsules, 5 mg/120 mgKV Pharmaceutical Co., 2503 South Hanley Rd., St. Louis,

MO 63144–2555.

ANDA 71–924 Clorazepate Dipotassium Capsules, 3.75 mg Purepac Pharmaceutical.

ANDA 71–925 Clorazepate Dipotassium Capsules, 7.5 mg Do.

ANDA 71–926 Clorazepate Dipotassium Capsules, 15 mg Do.

ANDA 80–087 Sulfisoxazole Tablets USP, 500 mg Do.

ANDA 80–395 Hydrocortisone Tablets, 20 mg Do.

ANDA 83–271 Niacin Tablets, 500 mg Do.

ANDA 84–020 Triamcinolone Tablets USP, 4 mg Do.

ANDA 84–247 Hydrocortisone Tablets, 10 mg Do.

ANDA 84–804 Meprobamate Tablets USP, 200 mg and 400 mg Do.

ANDA 84–939 Chlordiazepoxide Hydrochloride Capsules USP, 10 mg Do.

ANDA 85–144 Chlordiazepoxide Hydrochloride Capsules USP, 25 mg Do.

ANDA 85–155 Chlordiazepoxide Hydrochloride Capsules USP, 5 mg Do.

ANDA 85–753 Liothyronine Sodium Tablets, 50 micrograms Bolar Pharmaceutical Co., Inc., 130 Lincoln St., Copiague, NY

11726.

ANDA 85–904 Isoproterenol Hydrochloride Inhalation Aerosol USP, 0.25% Alpharma.

ANDA 86–110 Sustachron (Nitroglycerin Extended-release) Oral Tablets, 6.5

mg

Forest Laboratories, Inc., 909 Third Ave., New York, NY

10022–4731.

ANDA 86–112 Sustachron (Nitroglycerin Extended-release) Oral Tablets, 2.6

mg

Do.

ANDA 86–649 Sustachron (Nitroglycerin) Tablets, 10 mg Do.

ANDA 87–110 Nitroglycerin Extended-release Capsules KV Pharmaceutical Co.

ANDA 87–683 Pentaerythritol Tetra-nitrate Extended-release Capsules, 80

mg

Inwood Laboratories, Inc., 909 Third Ave., New York, NY

10022–4731.

ANDA 87–995 THEO–DUR (Theophylline Sustained-release Capsules)

Sprinkle, 200 mg

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

07033.
50390 Federal Register / Vol. 62, No. 186 / Thursday, September 25, 1997 / Notices

Application No. Drug Applicant

ANDA 88–015 THEO–DUR (Theophylline Sustained-release Capsules)

Sprinkle, 75 mg

Do.

ANDA 88–016 THEO–DUR (Theophylline Sustained-release Capsules)

Sprinkle, 125 mg

Do.

ANDA 88–022 THEO–DUR (Theophylline Sustained-release Capsules)

Sprinkle, 50 mg

Do.

ANDA 88–066 Hydrocone Bitartrate and Homatropine Methylbromide Syrup,

5 mg/1.5 mg per5 mL

Halsey Drug Co., 1827 Pacific St., Brooklyn, NY 11233.

ANDA 88–112 Tripodrine (Triprolidine and Pseudoephedrine Hydrochlorides

Tablets USP) 2.5 mg/60 mg

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

ANDA 88–140 Chlorthalidone Tablets USP, 50 mg Purepac Pharmaceutical.

ANDA 88–178 Hydralazine Hydrochloride Tablets, 50 mg Do.

ANDA 88–360 Fluocinolone Acetonide Cream USP, 0.025% Alpharma.

ANDA 88–361 Fluocinolone Acetonide Cream USP, 0.01% Do.

ANDA 88–950 Tolbutamide Tablets, 500 mg Purepac Pharmaceutical.

ANDA 88–997 Dexamethasone Elixir USP, 0.5 mg/5 mL Alpharma.

ANDA 89–754 Hydrocortisone Cream USP, 2.5% Do.

ANDA 89–840 Procainamide Hydrochloride Extended-release Tablets, 500

mg

Inwood Laboratories.

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 25, 1997.

Dated: September 11, 1997.

Janet Woodcock,

Director, Center for Drug Evaluation and

Research.

[FR Doc. 97–25369 Filed 9–24–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Delegation of Authority

Notice is hereby given that I have

delegated to the Director, Centers for

Disease Control and Prevention, with

authority to redelegate, the following

authorities vested in the Secretary of

Health and Human Services under Title

XXVI of the Public Health Service Act,

‘‘Health Care Services Program,’’ and

the Ryan White Care Act Amendments

of 1996 (P.L. 104–146), as amended

hereafter, insofar as these authorities

pertain to the functions assigned to the

Centers for Disease Control and

Prevention:

Section 2625—CDC Guidelines for Pregnant

Women

Section 2626—Perinatal Transmission of HIV

Disease; Contingent Requirement

Regarding State Grants Under This Part

Section 2628—Report by the Institute of

Medicine

Sections 2641–2650—Formula Grants for

States

Sections 2661–2667—General Provisions

Section 2675—Coordinaiton

Section 2680—Grants to States and political

subdivisions of States to implement

guidelines and model curriculum for

health workers and public safety workers,

including emergency response employees.

Sections 2681–2690—Notificaiton of Possible

Exposure to Infectious Diseases

The Centers for Disease Control and

Prevention and the Health Resources

and Services Administration shall

cooperate in the implementation of

Section 2626(e).

This delegation shall be excised under

the Department’s existing delegation of

authority and policy on regulations.

This delegation became effective upon

date of signature. In addition, I have

affirmed and ratified any actions taken

by the Director, Centers for Disease

Control and Prevention or his

subordinates which involved the

exercise of the authorities delegated

herein prior to the effective date of the

delegation.

Dated: September 15, 1997.

Donna E. Shalala,

Secretary.

[FR Doc. 97–25467 Filed 9–24–97; 8:45 am]

BILLING CODE 4160–18–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–R–97]

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;

(2) the accuracy of the estimated

burden; (3) ways to enhance the quality,

utility, and clarity of the information to

be collected; and (4) the use of

automated collection techniques or

other forms of information technology to

minimize the information collection

burden.

Type of Information Collection

Request: Reinstatement, without change,

of a previously approved collection for

which approval has expired; Title of

Information Collection: Requirement to

Disclose HMO Financial Information to

Members and Supporting Regulations in

42 CFR 417.124; Form No.: HCFA–R–

0097 (OMB 0938–0472); Use: Federally