26892 Federal Register / Vol. 60, No. 97 / Friday, May 19, 1995 / Notices

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 June 19, 1995,

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: May 9, 1995.

George H. Pauli,

Acting Director, Office of Premarket

Approval, Center for Food Safety and Applied

Nutrition.

[FR Doc. 95–12296 Filed 5–18–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95N–0127]

Roussel Corp., et al.; Withdrawal of

Approval of 16 Abbreviated New Drug

Applications

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is withdrawing

approval of 16 abbreviated new drug

applications (ANDA’s). The holders of

the ANDA’s 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withdrawn.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: June 19, 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 ANDA’s 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

62–830 ................ Sterile Cefazolin Sodium, U.S.P. (bulk) .................................. Roussel Corp., 95 Chestnut Ridge Rd., P.O. Box 30,

Montvale, NJ 07645.

70–662 ................ Diazepam Injection, U.S.P., 5 milligrams (mg)/milliliter (mL) .. Fujisawa Pharmaceutical Co., Parkway North Center, Three

Parkway North, Deerfield, IL 60015–2548.

80–517 ................ Prednisolone Sodium Phosphate Injection, U.S.P., 20 mg/mL Steris Laboratories, Inc., 620 North 51st Ave., Phoenix, AZ

85043–4705.

80–702 ................ Vitamin A Palmitate Capsules, EQ 50,000 Units Base ........... Banner Pharmacaps, Inc., 1111 Jefferson Ave., Elizabeth,

NJ 07207.

83–531 ................ Dimenhydrinate Injection, U.S.P., 50 mg/mL .......................... Steris Laboratories, Inc.

83–593 ................ Chlorpheniramine Maleate Injection, U.S.P., 10 mg/mL ......... Do.

83–948 ................ Vitamin A Palmitate Capsules, EQ 50,000 Units Base ........... Banner Pharmacaps, Inc.

83–973 ................ Vitamin A Capsules, 50,000 U.S.P. Units ............................... Do.

85–591 ................ Chlorpromazine Hydrochloride Injection, U.S.P., 25 mg/mL ... Steris Laboratories, Inc.

86–419 ................ Testosterone Injection, U.S.P., 50 mg/mL .............................. Do.

86–420 ................ Testosterone Injection, U.S.P., 25 mg/mL .............................. Do.

86–468 ................ Procainamide Hydrochloride Extended-release Tablets,

U.S.P., 250 mg.

Parke-Davis, Division of Warner-Lambert Co., 2800 Plymouth Rd., Ann Arbor, MI 48105.

86–844 ................ Acetic Acid Otic Solution with Hydrocortisone, 2%/1% ........... Procter & Gamble Pharmaceuticals, 11370 Reed Hartman

Hwy. Cincinnati, OH 45241–2422.

86–845 ................ Acetic Acid Otic Solution, U.S.P., 2% ..................................... Do.

87–274 ................ Hydroxyzine Hydrochloride Injection, U.S.P., 25 mg/mL and

50 mg/mL.

Steris Laboratories, Inc.

88–642 ................ Diethylpropion Hydrochloride Tablets, U.S.P., 25 mg ............. Lemmon Co., 650 Cathill Rd., Sellersville, PA 18960.

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 ANDA’s listed

above, and all amendments and

supplements thereto, is hereby

withdrawn, effective June 19, 1995.

Dated: April 18, 1995.

Murray M. Lumpkin,

Deputy Director, Center for Drug Evaluation

and Research.

[FR Doc. 95–12295 Filed 5–18–95; 8:45 am]

BILLING CODE 4160–01–F

Public Health Service

Agency Forms Undergoing Paperwork

Reduction Act Review

Each Friday the Public Health Service

(PHS) publishes a list of information

collection requests under review, in

compliance with the Paperwork

Reduction Act (44 U.S.C. Chapter 35).

To request a copy of these requests, call

the PHS Reports Clearance Office on

(202) 690–7100.

The following requests have been

submitted for review since the list was

last published on May 12.

1. Studies of Adverse Reproductive

Outcomes in Female Occupational

Groups—New—The reproductive health

of a group of female workers exposed to

a particular environmental chemical

agent will be compared to the

reproductive health of a group of

working women with no occupational

exposure to known or suspected

reproductive toxicants. Respondents:

Individuals or households; Business or

other for-profit. Send comments to

Shannah Koss, Human Resources and

Housing Branch, New Executive Office

Building, Room 10235, Washington, DC

20503.
Federal Register / Vol. 60, No. 97 / Friday, May 19, 1995 / Notices 26893

No. of

respondents

No. of

responses

per respondent

Avg. burden/

response

Women .. 6,200 1 2.85 hours.

Physicians.1,200 1 .5 hour.

Estimated Annual Burden: 18,250

hours.

2. Infant Feeding Study Puberty

Follow-up—0925–0381—Extension, no

change—Children from a previous study

of health effects of PCBs and DDE are

being restudied to determine whether

PCBs or DDE affect growth or pubertal

development. Information is being

collected annually from 431 children

and their parents to determine whether

there is public health concern about

these chemicals in children.

Respondents: Individuals or

households; Number of Respondents:

862; Number of Responses per

Respondent: 1.1; Average Burden per

Response: 0.23 hour; Estimated Annual

Burden: 219 hours. Send comments to

James Scanlon, Office of the Assistant

Secretary for Health, Room 737–F,

Humphrey Building, 200 Independence

Ave., SW., Washington, DC 20201.

3. FDA Recall Regulations—0910–

0249—Extension, no change—Recall

guidelines set forth procedures to be

used by manufacturers and distributors

or other responsible persons in notifying

or alerting health professionals or other

persons of an unreasonable risk of

substantial harm to the public’s health

and describe the procedures used or

required by FDA in the recall process.

Respondents: Business or other forprofit. Send comments to Shannah Koss,

Human Resources and Housing Branch,

New Executive Office Building, Room

10235, Washington, DC 20503.

No. of

respondents

No. of responses/

respondents

Avg. burden/response

21 CFR

7.42.

1,294 1 1.8 hours.

21 CFR

7.46/

7.49.

1,294 1 4 hours.

21 CFR

7.53.

1,294 1 36 hours.

21 CFR

7.55(b).

1,294 1 2 hours.

Estimated Annual Burden: 56,677

hours.

Written Comments and

recommendations concerning the

proposed information collections

should be sent within 30 days of this

notice directly to the individual

designated.

Dated: May 12, 1995.

James Scanlon,

Director, Data Policy Staff, Office of the

Assistant Secretary for Health and PHS

Report Clearance Officer.

[FR Doc. 95–12256 Filed 5–18–95; 8:45 am]

BILLING CODE 4160–01–M

Substance Abuse and Mental Health

Services Administration

Advisory Committee for Women’s

Services; Meeting

Pursuant to Pub.L. 92–463, notice is

hereby given of the meeting of the

Advisory Committee for Women’s

Services of the Substance Abuse and

Mental Health Services Administration

(SAMHSA).

The meeting of the Advisory

Committee for Women’s Services will

include a discussion of policy and

program issues relating to women’s

substance abuse and mental health

service needs at SAMHSA, including

the SAMHSA FY 1996 budget, the

SAMHSA Strategic Plan, and on-going

women’s activities within SAMHSA’s

Center for Substance Abuse Prevention,

Center for Substance Abuse Treatment

and Center for Mental Health Services.

A summary of the meeting and/or a

roster of committee members may be

obtained from: Jennifer B. Fiedelholtz,

Executive Secretary, Advisory

Committee for Women’s Services, Office

for Women’s Services, Substance Abuse

and Mental Health Services

Administration, Parklawn Building,

Room 13–99, 5600 Fishers Lane,

Rockville, Maryland 20857, Telephone:

(301) 443–5184.

Substantive information may be

obtained from the contact whose name

and telephone number is listed below.

Committee Name: Advisory Committee for

Women’s Services.

Meeting Date: June 12–13, 1995.

Place: Conference Room B, Parklawn

Building, 5600 Fishers Lane, Rockville,

Maryland 20857.

Open: 8:30 a.m. to 5 p.m.

Contact: Jennifer B. Fiedelholtz, Room 13–

99, Parklawn Building, Telephone (301) 443–

5184.

Dated: May 15, 1995.

Jeri Lipov,

Committee Management Officer, Substance

Abuse and Mental Health Services

Administration.

[FR Doc. 95–12331 Filed 5–18–95; 8:45 am]

BILLING CODE 4162–20–P

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

Office of the Assistant Secretary for

Community Planning and

Development

[Docket No. N–95–1917; FR–3778–N–37]

Federal Property Suitable as Facilities

To Assist the Homeless

AGENCY: Office of the Assistant

Secretary for Community Planning and

Development, HUD.

ACTION: Notice.

SUMMARY: This Notice identifies

unutilized, underutilized, excess, and

surplus Federal property reviewed by

HUD for suitability for possible use to

assist the homeless.

ADDRESSES: For further information,

contact David Pollack, room 7256,

Department of Housing and Urban

Development, 451 Seventh Street SW,

Washington, DC 20410; telephone (202)

708–1234; TDD number for the hearingand speech-impaired (202) 708–2565

(these telephone numbers are not tollfree), or call the toll-free Title V

information line at 1–800–927–7588.

SUPPLEMENTARY INFORMATION: In

accordance with 56 FR 23789 (May 24,

1991) and section 501 of the Stewart B.

McKinney Homeless Assistance Act (42

U.S.C. 11411), as amended, HUD is

publishing this Notice to identify

Federal buildings and other real

property that HUD has reviewed for

suitability for use to assist the homeless.

The properties were reviewed using

information provided to HUD by

Federal landholding agencies regarding

unutilized and underutilized buildings

and real property controlled by such

agencies or by GSA regarding its

inventory of excess or surplus Federal

property. This Notice is also published

in order to comply with the December

12, 1988 Court Order in National

Coalition for the Homeless v. Veterans

Administration, No 88–2503–OG

(D.D.C.).

Properties reviewed are listed in this

Notice according to the following

categories: Suitable/available, suitable/

unavailable, suitable/to be excess, and

unsuitable. The properties listed in the

three suitable categories have been

reviewed by the landholding agencies,

and each agency has transmitted to

HUD: (1) Its intention to make the

property available for use to assist the

homeless, (2) its intention to declare the

property excess to the agency’s needs, or

(3) a statement of the reasons that the

property cannot be declared excess or

made available for use as facilities to

assist the homeless.