Federal Register / Vol. 60, No. 47 / Friday, March 10, 1995 / Notices 13161

batches are not practicable. The sponsor

may create an alternative plan to that

recommended in order to compare the

bioavailability and stability

characteristics of the test and

production batch. Another major change

to the guidelines is the provision of an

alternate means by which sponsors may

meet the supplemental application

recommendations for alternate

manufacturing sites and alternate

sources of bulk drug substance when

multiple NADA’s and ANADA’s are

affected. The sponsor may request that

pilot batches of representative drug

products within the same dosage form

class be manufactured instead of

producing pilot batches of all affected

drug products.

These ‘‘Animal Drug Manufacturing

Guidelines, 1994’’ are not intended to be

individual stand-alone documents.

Much of the information presented in

one guideline may be equally important

to the correct interpretation of the other

guidelines. Therefore, all four

guidelines are being issued

concurrently.

Guidelines state procedures or

practices that may be useful to the

persons to whom they are directed, but

are not legal requirements. The agency

is in the process of revising §§ 10.85(d)

and 10.90(b) (21 CFR 10.85(d) and

10.90(b)). Therefore, these guidelines

are not being issued under authority of

present §§ 10.85(d) and 10.90(b). A

person may follow the guideline or may

choose to follow alternate procedures or

practices. If a person chooses to use

alternate procedures or practices, that

person may wish to discuss the matter

further with the agency to prevent an

expenditure of money and effort on

activities that may later be determined

to be unacceptable to FDA. A guideline

does not bind the agency, and it does

not create or confer any rights,

privileges, or benefits for or on any

person. When a guideline states a

requirement imposed by statute or

regulation, however, the requirement is

law and its force and effect are not

changed in any way by virtue of its

inclusion in the guideline.

Interested persons may, at any time,

submit to the Dockets Management

Branch (address above) written

comments on the guideline. 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. The guideline and received

comments are available for public

examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

Received comments will be

considered to determine if further

revision of the guideline is necessary.

Dated: March 6, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95–6006 Filed 3–9–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95N–0058]

Drug Export; Bulk Drug Substance

Paclitaxel

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that NaPro BioTherapeutics, Inc., has

filed an application requesting approval

for the export of the bulk human drug

substance Paclitaxel for formulation,

filling, and packaging into AnzataxTM

Injection Concentrate 30 milligrams

(mg) paclitaxel in 5 milliliter (mL) vials

to Australia.

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

NaPro BioTherapeutics, Inc., 4725

Walnut St., suite 100, Boulder, CO

80301, has filed an application

requesting approval for the export of the

bulk human drug substance Paclitaxel

for formulation, filling, and packaging

into AnzataxTM Injection Concentrate 30

mg paclitaxel in 5 mL vials to Australia.

This product is indicated for the

treatment of refractory ovarian cancer.

The application was received and filed

in the Center for Drug Evaluation and

Research on October 21, 1994, which

shall be considered the filing date for

purposes of the act.

Interested persons may submit

relevant information on the application

to the Dockets Management Branch

(address above) in two copies (except

that individuals may submit single

copies) and identified with the docket

number found in brackets in the

heading of this document. These

submissions may be seen in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

The agency encourages any person

who submits relevant information on

the application to do so by March 20,

1995, and to provide an additional copy

of the submission directly to the contact

person identified above, to facilitate

consideration of the information during

the 30-day review period.

This notice is issued under the

Federal Food, Drug, and Cosmetic Act

(sec. 802 (21 U.S.C. 382)) and under

authority delegated to the Commissioner

of Food and Drugs (21 CFR 5.10) and

redelegated to the Center for Drug

Evaluation and Research (21 CFR 5.44).

Dated: March 2, 1995.

Edward Miracco,

Acting Deputy Director, Office of Compliance,

Center for Drug Evaluation and Research.

[FR Doc. 95–6005 Filed 3–9–95; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Social Security Administration

Agency Forms Submitted to the Office

of Management and Budget for

Clearance

Normally on Fridays, the Social

Security Administration publishes a list

of information collection packages that

have been submitted to the Office of

Management and Budget (OMB) for

clearance in compliance with P.L. 96–

511, The Paperwork Reduction Act. The

following clearance packages have been

submitted to OMB since the last list was

published in the Federal Register on

February 10, 1995. (Call Reports
13162 Federal Register / Vol. 60, No. 47 / Friday, March 10, 1995 / Notices

Clearance Officer on (410) 965–4142 for

copies of package.)

1. Real Property Current Market

Value—0960–0471. The information on

form SSA–2794 is used by the Social

Security Administration to determine

the value of non-home real property

owned by applicants for or recipients of

Supplemental Security Income. The

respondents are persons experienced in

estimating the current market of real

property.

Number of Respondents: 6,188

Frequency of Response: 1

Average Burden Per Response: 20

minutes

Estimated Annual Burden: 2,063 hours

2. Employer Verification of Earnings

After Death—0960–0472. The

information on form SSA–L4112 is used

by the Social Security Administration to

determine whether wages reported by

an employer are correct, when SSA

records indicate the wage earner is

deceased. The respondents are

employers who report wages for a

deceased employee.

Number of Respondents: 50,000

Frequency of Response: 1

Average Burden Per Response: 10

minutes

Estimated Annual Burden: 8,333 hours

3. Farm Self-Employment

Questionnaire—0960–0061. The

information on form SSA–7156 is used

by the Social Security Administration to

determine whether an agricultural trade

or business exists and possible covered

earnings for Social Security entitlement

purposes. The respondents are

claimants for benefits who allege

covered earnings from agricultural selfemployment.

Number of Respondents: 47,500

Frequency of Response: 1

Average Burden Per Response: 10

minutes

Estimated Annual Burden: 7,917 hours

4. SSI PE Returned Check

Questionnaire—0960–NEW. The

information on form SSA–281 will be

used by the Social Security

Administration to improve the accuracy

of the SSA PE returned check process.

The purpose of the questionnaire is to

collect statistical information needed to

identify areas which are deficient,

thereby improving service to the public

and reducing Government expenditures.

The respondents are SSI beneficiaries or

their representative payees.

Number of Respondents: 1,000

Frequency of Response: 1

Average Burden Per Response: 15

minutes

Estimated Annual Burden: 250 hours

5. Report by Former Representative

Payee—0960–0112. The information on

form SSA–625 is used by the Social

Security Administration to determine if

State institutions or agencies which

were formerly payees for Social Security

benefits have properly used such funds.

The respondents are State institutions or

agencies who have terminated

representative payee services.

Number of Respondents: 8,000

Frequency of Response: 1

Average Burden Per Response: 15

minutes

Estimated Annual Burden: 2,000 hours

6. Certificate of Support—0960–0001.

The information on form SSA–760 is

used by the Social Security

Administration to determine if a parent

of a deceased wage earner or a spouse

receiving a Government pension meets

the one-half support requirement for

entitlement to benefits. The respondents

are parents of deceased wage earners

and spouses who are entitled to receive

a Government pension.

Number of Respondents: 18,000

Frequency of Response: 1

Average Burden Per Response: 15

minutes

Estimated Annual Burden: 4,500 hours

OMB Desk Officer: Laura Oliven.

Written comments and

recommendations regarding these

information collections should be sent

directly to the appropriate OMB Desk

Officer designated above at the

following address: Office of

Management and Budget, OIRA, New

Executive Office Building, Room 10230,

Washington, D.C. 20503.

Dated: March 6, 1995.

Charlotte Whitenight,

Reports Clearance Officer, Social Security

Administration.

[FR Doc. 95–5829 Filed 3–9–95; 8:45 am]

BILLING CODE 4190–29–P

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

Office of Administration

[Docket No. R–95–1771/3881; FR–3844/

3859–N–02]

Notice of Submission of Proposed

Information Collection to OMB

AGENCY: Office of Administration, HUD.

ACTION: Notice.

SUMMARY: The proposed information

collection requirement described below

has been submitted to the Office of

Management and Budget (OMB) for

review, as required by the Paperwork

Reduction Act. The Department is

soliciting public comments on the

subject proposal.

ADDRESS: Interested persons are invited

to submit comments regarding this

proposal. Comments must be received

within thirty (30) days from the date of

this Notice. Comments should refer to

the proposal by name and should be

sent to: Joseph F. Lackey, Jr., OMB Desk

Officer, Office of Management and

Budget, New Executive Office Building,

Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT:

Kay F. Weaver, Reports Management

Officer, Department of Housing and

Urban Development, 451 7th Street,

Southwest, Washington, DC 20410,

telephone (202) 708–0050. This is not a

toll-free number. Copies of the proposed

forms and other available documents

submitted to OMB may be obtained

from Ms. Weaver.

SUPPLEMENTARY INFORMATION: The

Department has submitted the proposal

for the collection of information, as

described below, to OMB for review, as

required by the Paperwork Reduction

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

The Notice lists the following

information: (1) The title of the

information collection proposal; (2) the

office of the agency to collect the

information; (3) the description of the

need for the information and its

proposed use; (4) the agency form

number, if applicable; (5) what members

of the public will be affected by the

proposal; (6) an estimate of the total

number of hours needed to prepare the

information submission including

number of respondents, frequency of

response, and hours of response; (7)

whether the proposal is new or an

extension, reinstatement, or revision of

an information collection requirement;

and (8) the names and telephone

numbers of an agency official familiar

with the proposal and of the OMB Desk

Officer for the Department.

Authority: Section 3507 of the Paperwork

Reduction Act, 44 U.S.C. 3507; Section 7(d)

of the Department of Housing and Urban

Development Act, 42 U.S.C. 3535(d).

Dated: February 27, 1995.

David S. Cristy,

Acting Director, Information Resources and

Management Policy and Management

Division.

Notice of Submission of Proposed

Information Collection to OMB

Proposal: Enterprise Zones

Homeownership Opportunity Grant (EZ

Homes) (FR–3844/3859).

Office: Housing.

Description of the Need for the

Information and its Proposed Use:

Section 186 of the Housing and Urban

Development Act of 1992 (HCDA 1992)

(P.L. 102–550, approved October 28,