10592 Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Notices

Receipt of

new/revised/

supplementary/

competitive renewal applications

Initial

review

Secondary

review

Earliest

award

date

May 1, 1995 ... June .. July ... Aug. 1,

1995.

FUTURE RECEIPT DATES ARE AS FOLLOWS:

Receipt of

new/revised/

supplementary/

competitive renewal applications

Initial

review

Secondary

review

Earliest

award

date

April ................ June .. July ... Aug.

Where to Obtain Additional

Information

All application procedures and

guidelines are contained within this

program announcement. Business

management technical assistance may

be obtained from Maggie Slay, Grants

Management Specialist, Centers for

Disease Control and Prevention (CDC),

255 East Paces, Ferry Road, NE.,

Mailstop E13, Atlanta, GA 30305,

telephone (404) 842–6797.

Programmatic technical assistance may

be obtained from Tom Voglesonger,

Program Manager, Injury Control

Research Centers, National Center for

Injury Prevention and Control, Centers

for Disease Control and Prevention

(CDC), 4770 Buford Highway, Mailstop

K58, Atlanta, GA 30341–3724,

telephone (404) 488–4265.

Potential applicants may obtain a

copy of ‘‘Healthy People 2000’’ (Full

Report, Stock No. 017–001–00474–0) or

‘‘Healthy People 2000’’ (Summary

Report; Stock No. 017–001–00473–1)

through the Superintendent of

Documents, Government Printing

Office, Washington, DC 20402–9325,

telephone (202) 783–3238.

Dated: February 21, 1995.

Joseph R. Carter,

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 95–4684 Filed 2–24–95; 8:45 am]

BILLING CODE 4163–18–P

Food and Drug Administration

[Docket No. 94D–0386]

Revised FDA Form 3210 Application

for Establishment License for

Manufacture of Biological Products (4/

94); Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of the revised FDA Form

3210 Application for Establishment

License for Manufacture of Biological

Products (4/94). This form replaces the

previous edition of FDA Form 3210 (12/

88). FDA Form 3210 is used by

manufacturers to apply for licensure of

a facility for the manufacture of

biological products regulated under the

Public Health Service Act. The form has

been revised because of inadequacies in

the previous form that resulted in

requests by the agency for supplemental

information. The revised form is

intended to shorten review time and

decrease expenditure of resources for

both the agency and industry.

DATES: FDA will continue to accept

submissions using the previous Form

3210 (12/88) until August 28, 1995.

FOR FURTHER INFORMATION CONTACT:

Timothy W. Beth, Center for Biologics

Evaluation and Research (HFM–635),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–594–3074.

ADDRESSES: Submit written requests for

single copies of the revised FDA Form

3210 Application for Establishment

License for Manufacture of Biological

Products (4/94) to Division of

Congressional and Public Affairs (HFM–

11), Center for Biologics Evaluation and

Research (CBER), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448, 301–594–

1800. Requests should be identified

with the docket number found in

brackets in the heading of this

document. Send two self-addressed

adhesive labels to assist that office in

processing your requests. The form may

also be obtained by calling the CBER

FAX Information System at 301–594–

1939 from a FAX machine with a touch

tone phone attached or built in. FDA

Form 3210 Application for

Establishment License for Manufacture

of Biological Products (4/94) is available

for public examination in the Dockets

Managements Branch (HFA–305), Food

and Drug Administration, rm. 1–23,

12420 Parklawn Dr., Rockville, MD

20857, between 9 a.m. and 4 p.m.,

Monday through Friday.

SUPPLEMENTARY INFORMATION: FDA is

making available revised FDA Form

3210 Application for Establishment

License for Manufacture of Biological

Products (4/94). The form was revised

due to inadequacies in the old form

which made the application review

process cumbersome and difficult for

both the agency and industry. In the

past, the review process was often

significantly lengthened because of

requests by the agency for supplemental

information from the manufacturer in

order to ensure the safety, purity,

potency, and efficacy of manufactured

biological products. The revised form

details more specifically the information

that is required for establishment

licensure. FDA believes that the revised

form will expedite the review process

by reducing the need for supplemental

information requests and responses.

The revised form solicits information

from the manufacturer in the following

areas: (1) General information (names

and addresses); (2) water systems; (3)

heating ventilation and air conditioning

systems; (4) raw materials and ancillary

facilities; (5) source materials; (6)

propagation of host systems; (7)

intermediate processing; (8) formulation

and final product preparation; (9)

computer systems; (10) support areas;

(11) quality control areas; (12) animal

facilities for testing; (13) animal

facilities for production; (14) calibration

and validation; and (15) records.

In addition, the revised form also

requires the following information to be

submitted: A description of the lot

numbering system, an organizational

chart, an environmental assessment

report, written agreements, curriculum

vitae for key manufacturing and

responsible personnel, and an overview

of the current good manufacturing

practices (CGMP) training program. A

comments section is provided on the

revised form for additional information

that the manufacturer deems to be

appropriate but may not be covered

under other sections.

Manufacturers preparing to submit

applications for establishment licensure

should now utilize the revised (4/94)

form. FDA will continue to accept

submissions using the previous (12/88)

form until August 28, 1995. Because the

old form does not address specific

questions and issues that are present on

the revised form, additional review

cycles should be anticipated when using

the previous form.

Under the Paperwork Reduction Act

of 1980 (Pub. L. 96–511) all forms

requesting a collection of information
Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Notices 10593

on identical items from 10 or more

public respondents must be approved

by the Office of Management and

Budget (OMB) and must display a valid

OMB control number and expiration

date.

In accordance with the Paperwork

Reduction Act, in the Federal Register

of February 4, 1994 (59 FR 5436), a

notice announced the proposed revision

of FDA Form 3210 Application For

Establishment License for Manufacture

of Biological Products. OMB approval

for the revised FDA Form 3210 was

obtained on April 30, 1994, and given

OMB approval number 0910–0124;

expiration date April 30, 1997.

Dated: February 17, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95–4766 Filed 2–24–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95N–0042]

Drug Export; OGEN (Piperazine

Oestrone Sulfate) 0.625 Milligram (mg),

1.25 mg, and 2.5 mg Tablets

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Abbott Laboratories has filed an

application requesting approval for the

export of the human drug OGEN

(piperazine oestrone sulfate) 0.625

milligram (mg), 1.25 mg, and 2.5 mg

Tablets 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

Abbott Laboratories, One Abbott Park

Rd., Abbott Park, IL 60064–3500, has

filed an application requesting approval

for the export of the human drug OGEN

(piperazine oestrone sulfate) 0.625 mg,

1.25 mg, and 2.5 mg Tablets to

Australia. This product is indicated for

replacement therapy of oestrogen

deficiency in female hypogonadism,

amenorrhoea, female castration, primary

ovarian failure, and in the management

of menopausal syndrome, senile

vaginitis, kraurosis vulvae with or

without pruritus, and abnormal uterine

bleeding due to hormonal imbalance in

the absence of organic pathology. The

firm has new drug application approval

for OGEN (piperazine oestrone sulfate)

in the above dosage strengths using a

different manufacturing process. The

application was received and filed in

the Center for Drug Evaluation and

Research on October 31, 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 9,

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: February 9, 1995.

Edward Miracco,

Acting Deputy Director, Office of Compliance,

Center for Drug Evaluation and Research.

[FR Doc. 95–4768 Filed 2–24–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 94D–0422]

Draft Guideline on the Manufacture of

Positron Emission Tomography

Radiopharmaceutical Drug Products;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guideline entitled

‘‘Draft Guideline on the Manufacture of

Positron Emission Tomographic (PET)

Drug Products’’ prepared by FDA’s

Center for Drug Evaluation and Research

(CDER). The draft guideline is intended

to assist persons in determining whether

certain manufacturing practices,

procedures, and facilities used in the

small-scale production of liquid

injectable radiopharmaceutical drug

products used for positron emission

tomography (PET radiopharmaceuticals)

are in compliance with FDA’s current

good manufacturing practice (CGMP)

regulations for finished

pharmaceuticals.

DATES: Written comments by May 30,

1995.

ADDRESSES: Submit written requests for

single copies of the draft guideline

entitled ‘‘Draft Guideline on the

Manufacture of Positron Emission

Tomographic (PET) Drug Products’’ to

the CDER Executive Secretariat Staff

(HFD–8), Center for Drug Evaluation

and Research, Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855. Send two selfaddressed adhesive labels to assist that

office in processing your requests.

Submit written comments on the draft

guideline to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, rm. 1–23, 12420

Parklawn Dr., Rockville, MD 20857.

Requests and comments should be

identified with the docket number

found in brackets in the heading of this

document. A copy of the draft 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.

FOR FURTHER INFORMATION CONTACT: John

W. Levchuk, Center for Drug Evaluation

and Research (HFD–322), Food and