8662 Federal Register / Vol. 60, No. 31 / Wednesday, February 15, 1995 / Notices

approval of five new animal drug

applications (NADA’s), one held by

Pfizer, Inc., and four NADA’s held by

Premiere Agri Technologies, Inc. Pfizer,

Inc., notified FDA that its

oxytetracycline soluble powder is no

longer marketed. Premiere Agri

Technologies, Inc., notified FDA that its

approved NADA’s are no longer

required to manufacture Type B

medicated feeds containing tylosin or

virginiamycin. For these reasons, both

sponsors requested that approval of the

applications be withdrawn. In a final

rule published elsewhere in this issue of

the Federal Register, FDA is amending

the regulations by removing the entries

which reflect approval of the NADA’s.

EFFECTIVE DATE: February 27, 1995.

FOR FURTHER INFORMATION CONTACT:

Mohammad I. Sharar, Center for

Veterinary Medicine (HFV–216), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–594–

1722.

SUPPLEMENTARY INFORMATION: FDA has

been informed by : (1) Pfizer, Inc., that

it is no longer manufacturing or

marketing its oxytetracycline soluble

powder, and (2) Premiere Agri

Technologies, Inc., that approval of its

NADA’s listed in the table is no longer

required to manufacture Type B

medicated feeds containing tylosin or

virginiamycin (Type A medicated

articles containing tylosin are covered

by another NADA). Accordingly, both

firms requested in writing that FDA

withdraw approval of the applications.

NADA

No. Drug name Sponsor nameand address

10–661 . Oxytetracycline

soluble powder

(Terramycin

Egg Formula).

Pfizer, Inc., 235

East 42d St.,

New York,

NY 10017

45–690 . Tylosin Type B

medicated

feeds and

Type A medicated article.

Premiere Agri

Technologies,

Inc., P.O. Box

2508, Fort

Wayne, IN

46801–2508

(former sponsor Henwood

Feed Additives)

97–289 . Tylosin Type B

medicated

feeds and

Type A medicated article.

Do. (Former

sponsor Feed

Specialties

Co., Inc.)

NADA

No. Drug name Sponsor nameand address

133–361 Virginiamycin

Type B medicated feed.

Do. (Former

sponsor Feed

Specialties

Co., Inc.)

133–839 Virginiamycin

Type B medicated feed.

Do. (Former

sponsor

MAC-PAGE,

Inc.)

Therefore, under authority delegated

to the Commissioner of Food and Drugs

(21 CFR 5.10) and redelegated to the

Center for Veterinary Medicine (21 CFR

5.84), and in accordance with § 514.115

Withdrawal of approval of applications

(21 CFR 514.115), notice is given that

approval of NADA’s 10–661, 45–690,

97–289, 133–361, and 133–839 and all

supplements and amendments thereto is

hereby withdrawn, effective February

27, 1995.

In a final rule published elsewhere in

this issue of the Federal Register, FDA

is: (1) Amending 21 CFR 558.625 by

removing and reserving paragraphs

(b)(11) and (b)(15) to reflect the

withdrawal of approval of NADA’s 45–

690 and 97–289 and (2) amending 21

CFR 558.635(b)(2) to reflect the

withdrawal of approval of NADA’s 133–

361 and 133–839. It is unnecessary to

amend the regulations to reflect

withdrawal of approval of NADA 10–

661 because it is not codified.

Dated: January 6, 1995.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 95–3801 Filed 2–14–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95N–0024]

Somatic Cell and Gene Therapy

Manufacturing Issues; Public Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA), Center for

Biologics Evaluation and Research

(CBER), is announcing a public meeting

to discuss somatic cell and gene therapy

production issues. The meeting is

designed to discuss several issues

related to the limited access to ancillary

components on the development of

somatic cell and gene therapies and to

solicit public testimony regarding these

issues.

DATES: The public meeting will be held

on Monday, March 6, 1995, from 6 p.m.

to 7:30 p.m., immediately following the

National Institutes of Health,

Recombinant DNA Advisory Committee

meeting. Submit written requests for

participation and written copies or

summaries of oral presentations, or any

written comments for possible

discussion at the meeting by February

27, 1995. Written comments may also be

submitted after the meeting to the

Dockets Management Branch (address

below).

ADDRESSES: The public meeting will be

held at the National Institutes of Health,

Bldg. 31C, 9000 Rockville Pike,

conference room 6, Bethesda, MD. No

registration is required to attend the

meeting. Submit to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, rm. 1–23,

12420 Parklawn Dr., Rockville, MD

20857, written requests for participation

and written copies or summaries of oral

presentations, or any 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.

FOR FURTHER INFORMATION CONTACT:

For information regarding the

meeting: John G. Bishop, Center for

Biologics Evaluation and Research

(HFM–515), Food and Drug

Administration, 1401 Rockville

Pike, Rockville, MD 20852–1448,

301–402–1336, FAX 301–496–7027.

For information regarding this notice:

Stephen M. Ripley, Center for

Biologics Evaluation and Research

(HFM–635), Food and Drug

Administration, 1401 Rockville

Pike, Rockville, MD 20852–1448,

301–594–3074.

SUPPLEMENTARY INFORMATION: The field

of gene and somatic cell therapy is

rapidly evolving. FDA is interested in

exploring approaches to overcome

barriers to the development of novel and

useful therapeutics for a variety of

human diseases without diminishing

patient safety. To facilitate this process,

FDA is holding a public meeting to

discuss practical concerns relating to

gene therapy vector production and

somatic cell production.

In recent months, FDA has been asked

by several sponsors of clinical

investigations conducted under

investigational new drug applications to

allow modifications to gene therapy

protocols, due to limited access to

critical reagents and products, e.g.,

growth factors used in the expansion of

cells for somatic cell and gene therapies.

Limited access to ancillary components

could potentially lead to the adoption of

suboptimal somatic cell and gene

therapy procedures which might affect

the investigation of the safety and
Federal Register / Vol. 60, No. 31 / Wednesday, February 15, 1995 / Notices 8663

efficacy of somatic cell and gene therapy

products. This limited access may, in

the long term, unduly restrict progress

in the field of somatic cell and gene

therapy in the United States.

To obtain more information, FDA

would like to discuss several issues

related to the limited access to ancillary

components on the development of

somatic cell and gene therapies,

including: (1) What are the ancillary

components that are most critical to

somatic cell and gene therapy trials? (2)

What are the main reasons for the lack

of availability of ancillary components?

(3) Are there alternate suppliers of

ancillary components? and (4) What is

the impact of the limited supply of

ancillary components on somatic cell

and gene therapy development?

FDA is soliciting public testimony

from biomedical researchers, university

faculty and administrators,

biotechnology associations, other

Federal and government agencies, and

other individuals and organizations

with relevant information concerning

limited access to critical ancillary

componets for gene therapy and somatic

cell therapy manufacturing. FDA also

solicits testimony, in particular, from

affected individuals and consumer

organizations. All interested parties are

invited to participate in the meeting.

Every effort will be made to

accommodate each person who wants to

participate in the public meeting.

However, because presentations will be

limited to the first 30 minutes of the

meeting, the time allotted for each

presentation will be restricted to 5

minutes. Due to the time limitations of

the meeting, all requests may not be

granted. Therefore, each person who

wants to participate in the meeting is

encouraged, by close of business on

February 27, 1995, to do the following:

(1) File a written request of participation

containing the name, address, phone

number, facsimile number, affiliation, if

any, of the participant, and topic of the

presentation, and (2) submit a copy or

summary of their presentation. The

requested information, including the

written notice of participation, may be

submitted to the Dockets Management

Branch (address above). After the

presentations, the remainder of the

meeting will be used to allow for

discussion.

Before the meeting, CBER will

determine the schedule for the

presenters. A schedule of the presenters

will be filed with the Dockets

Management Branch (address above)

and mailed or FAX’ed to each

participant before the meeting.

Interested persons attending the meeting

who did not request an opportunity to

make a presentation or those who did

request an opportunity to make a

presentation but due to the time

limitations were not granted the request

will be given the opportunity to make

an oral presentation at the conclusion

the meeting, as time permits.

FDA will consider information

presented and discussed at the meeting

in the developing of future points to

consider and regulatory and guidance

documents, and in identifying topics for

future discussion.

Transcripts of the public meeting may

be requested in writing from the

Freedom of Information Office (HFI–35),

Food and Drug Administration, rm.

12A–16, 5600 Fishers Lane, Rockville,

MD 20857, approximately 15 working

days after the meeting, at a cost of 10

cents per page. The transcript of the

public meeting and copies of

information and comments submitted to

the meeting record will be available for

examination at the Dockets Management

Branch (address above) approximately

15 working days after the meeting,

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

through Friday.

Dated: February 10, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95–3800 Filed 2–10–95; 3:00 pm]

BILLING CODE 4160–01–F

Indian Health Service

Health Professions Preparatory,

Pregraduate and Indian Health

Scholarship (Professions) Programs

AGENCY: Indian Health Service, HHS.

ACTION: Standing Notice of Availability

of Funds for Health Professions

Preparatory, Pregraduate and Indian

Health Scholarship (Professions)

Programs for Fiscal Years (FYs) 1995

and 1996.

SUMMARY: The Indian Health Service

(IHS) announces the availability of

approximately $3,578,200 to fund

scholarships for the Health Professions

Preparatory and Pregraduate

Scholarship Programs for FY 1995

awards. Pending the availability of

funds, a similar amount is anticipated in

FY 1996. These programs are authorized

by section 103 of the Indian health Care

Improvement Act (IHCIA), Pub. L. 94–

437, as amended by Pub. L. 100–713

and by Pub. L. 102–573.

The Indian Health Scholarship

(Professions) Program, authorized by

section 104 of the IHCIA, Pub. L. 94–

437, as amended by Pub. L. 100–713

and by Pub. L. 102–573, has

approximately $8,160,751 available for

FY 1995 awards. Pending the

availability of funds, a similar amount is

anticipated in FY 1996.

Scholarships under the three

programs will be awarded utilizing the

Notice of Grant Award, form PHS–

5152–1 (Rev. 7/92). For academic years

1995–1996 and 1996–1997, full-time

and part-time scholarships will be

funded for each of the three scholarship

programs.

The Health Professions Preparatory

Scholarship Program is listed as No. 93–

123 in the Office of Management and

Budget Catalog of Federal Domestic

Assistance (CFDA). The Health

Professions Pregraduate Scholarship

Program is listed as No. 93.971, and the

Indian Health Scholarship (Professions)

Program is listed as No. 93.972 in the

CFDA.

The Public Health Service (PHS) is

committed to achieving the health

promotion and disease prevention

objectives of Healthy People 2000, a

PHS-led activity for setting priority

areas. This program announcement is

related to the priority area of Education

and Community-Based programs.

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, D.C. 20402–9325

(Telephone 202–783–3238).

DATES: The application deadline is April

1, 1995 and 1996. If April 1 falls on the

week-end, the application will be due

on the following Monday. Applications

shall be considered as meeting the

deadline if they are received by the

appropriate Scholarship Coordinator on

the deadline date or postmarked on or

before the deadline date. (Applicants

should request a legibly dated U.S.

Postal Service postmark or obtain a

legibly dated receipt from a commercial

carrier or U.S. Postal Service. Private

metered postmarks shall not be

acceptable as proof of timely mailing.)

Applications received after the

announced closing date will be returned

to the applicant and will not be

considered for funding.

ADDRESSES: Application packets may be

obtained by calling or writing to the

addresses listed below. The IHS

Scholarship Program application forms

include: IHS–856, 856–2 through 856–8,

815, 816, 818 and, F–01 through L–04

(approved under OMB No. 0917–0006,

expires 12/31/97).