Federal Register / Vol. 61, No. 83 / Monday, April 29, 1996 / Notices 18749

‘‘Effective for the treatment of clinical and

subclinical mastitis caused by

Staphylococcus species such as

Staphylococcus aureus, and Streptococcus

species such as Streptococcus agalactiae,

Streptococcus uberis.’’

This would eliminate the need in a

clinical study to enroll 100 clinical

cases per pathogen per treatment group.

The study would need to demonstrate

adequate power to detect an overall

treatment-cure rate above that of the

untreated control group. This would

take into account spontaneous cure

rates.

CVM considered the above comments

and has revised the guidance document

accordingly in light of CVM’s position

on this issue. CVM believes that under

current regulations, use of positive

control studies are permitted, however,

CVM is trying to determine what

constitutes ‘‘efficacy threshold.’’ CVM

would still require a negative controlled

study in order to separate the

spontaneous cure rate from the cure rate

attributable to the drug. If a sponsor is

considering a positively controlled

study, the sponsor should provide a

basis for the need to have such a study,

and thus be exempted from this

standard. It should be discussed with

and approved by CVM prior to the

study. The design of the positively

controlled study needs to be such that

depending on the spontaneous cure

rates, the study would detect an overall

cure rate for the treatment group of 65

to 70 percent per pathogen.

6. Minimum Inhibitory Concentration/

Pharmacokinetic Data (MIC/PK Data)

The comment stated that utilization of

MIC/PK data for intramammary/mastitis

products is still in the scientific

discovery stage. The basis for correlating

milk residue/efficacy/MIC data to draw

a reasonable scientific conclusion is

unavailable.

CVM agrees with the above comment,

however, the use of MIC/PK data for

intramammary products should be

addressed when CVM considers the

flexible labeling issues and should not

be addressed in this current antiinfective bovine mastitis drug guidance

document.

7. Non-lactating Treatment and

Prevention Products

The comment stated that separate

studies would be necessary to obtain a

treatment and prevention label claim.

CVM agrees with the comment and

has revised the draft guidance to

indicate that separate studies would be

necessary to obtain a treatment and

prevention label claim for use in the dry

cow. For the prevention claim, the

sponsor would need to establish,

through a negative controlled group, the

new infection rate (estimates are

approximately 2 to 3 percent) and

demonstrate at least a 50 percent

reduction in the rate of new infections.

The criteria for defining a cure is as for

clinical mastitis in the lactating cow,

i.e., no clinical signs and negative

culture at time of freshening.

Guidelines are generally issued under

§§ 10.85(a) and 10.90(b) (21 CFR

10.85(a) and 10.90(b)). The agency is

now in the process of revising

§§ 10.85(a) and 10.90(b). Therefore, this

guidance document is not being issued

under §§ 10.85(a) and 10.90(b), and it

does not bind the agency, and does not

create or confer any rights, privileges, or

benefits for or on any person. However,

it represents the agency’s current

thinking on this issue. A person may

follow the guidance document or may

choose to follow alternative procedures

or practices. If a person chooses to use

alternate procedures or practices, that

person may wish to discuss the matter

with FDA/CVM to prevent an

expenditure of money and effort on

activities that may later be determined

to be unacceptable. When a guidance

document 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 guidance

document.

Interested persons may, at any time,

submit to the Dockets Management

Branch (address above) written

comments on the document. 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 guidance document and

received comments are available for

public examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

Dated: April 23, 1996.

William K. Hubbard,

Association Commissioner for Policy

Coordination.

[FR Doc. 96–10485 Filed 4–26–96; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 93F-0102]

Ciba-Geigy Corp.; Withdrawal of Food

Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

withdrawal, without prejudice to a

future filing, of a food additive petition

(FAP 3B4361), filed by Ciba-Geigy

Corp., proposing that the food additive

regulations be amended to provide for

safe use of the reaction product of 4,4′-

isopropylidenediphenolepichlorohydrin resin, 4,4′-

isopropylidenediphenol bis[(2-

glycidyloxy-3-n-butoxy)-1-propyl ether],

and 4,4′-isopropylidenediphenol as a

component of coatings for food-contact

use.

FOR FURTHER INFORMATION CONTACT:

Julius Smith, Center for Food Safety and

Applied Nutrition (HFS–216), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3091.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

April 19, 1993 (58 FR 21173), FDA

announced that a food additive petition

(FAP 3B4361) had been filed by CibaGeigy Corp., Seven Skyline Dr.,

Hawthorne, NY 10532–2188. The

petition proposed to amend the food

additive regulations in § 175.300

Resinous and polymeric coatings (21

CFR 175.300) to provide for the safe use

of the reaction product of 4,4′-

isopropylidenediphenolepichlorohydrin resin, 4,4′-

isopropylidenediphenol bis[(2-

glycidyloxy-3-n-butoxy)-1-propyl ether],

and 4,4′-isopropylidenediphenol as a

component of coatings for food-contact

use. Ciba-Geigy Corp. has now

withdrawn the petition without

prejudice to a future filing (21 CFR

171.7)

Dated: April 10, 1996.

Alan M. Rulis,

Director, Office of Premarket Approval,

Center for Food Safety and Applied Nutrition.

[FR Doc. 96–10547 Filed 4–26–96; 8:45 am]

BILLING CODE 4160–01–F

1996 Gene Therapy Conference:

Development and Evaluation of Phase

I Products and Workshop on Vector

Development; Notice of Public

Conference

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of public conference.

SUMMARY: The Food and Drug

Administration (FDA) is announcing a

public conference entitled ‘‘1996 Gene

Therapy Conference: Development and

Evaluation of Phase I Products and

Workshop on Vector Development.’’

The objective of this conference is to

educate investigators on the
18750 Federal Register / Vol. 61, No. 83 / Monday, April 29, 1996 / Notices

investigational new drug (IND) process,

points-to-consider documents, resources

available from the National Institutes of

Health (NIH) to bring gene therapy from

the research laboratory to clinical trials,

and to conduct a series of workshops on

various issues concerning the

development, production, and use of

viral vectors for gene therapy. FDA

believes that the conference will benefit

interested parties, including industry,

NIH, and FDA, involved in this rapidly

advancing and changing field of gene

therapy.

DATES: The public conference will be

held on Thursday and Friday, July 11

and 12, 1996, 8 a.m. to 5 p.m.

Preregistration is requested by June 28,

1996. Registration will be held on both

days from 7:30 a.m. to 8 a.m.

ADDRESSES: The public conference will

be held at NIH, Bldg. 45, Natcher

Auditorium, 9000 Rockville Pike,

Bethesda, MD. There is no registration

fee. For a complete description of the

conference, agendas, speakers, and

session chairs check the FDA Biologics

Home Page at http://www.fda.gov/cber/

cberftp.html. The home page will be

updated as the conference gets closer.

FOR FURTHER INFORMATION CONTACT:

Regarding information on registration:

Margaret Fanning, NCI–FCRDC,

P.O. Box B, Frederick, MD 21702–

1201, 301–846–5865, or FAX 301–

846–5866.

Regarding information on the

conference agenda: Bette A.

Goldman, Center for Biologics

Evaluation and Research (HFM–

500), 1401 Rockville Pike,

Rockville, MD 20852–1448, 301–

594–2860.

SUPPLEMENTARY INFORMATION: Gene

therapy is a dynamic and rapidly

advancing field of scientific study. The

purpose of this conference is twofold.

On July 11, 1996, FDA hopes to provide

the gene therapy community with an

education and understanding of the IND

review process. Many academic

investigators and researchers involved

in the research and development of gene

therapies are not familiar with the

regulatory process for the review of

IND’s. This lack of knowledge of the

IND process may decrease the efficiency

of pre-IND meetings and increase the

review burden on FDA staff. In order to

address this problem, the conference

will include a description of the IND

process, the use of ‘‘points-to-consider’’

and guideline documents, and resources

available from NIH to bring gene

therapy from the research laboratory to

clinical trials. On July 12, 1996, the

conference will serve as an opportunity

for FDA to hear concerns, issues, and

ideas from the gene therapy community.

There will be presentations of the

available scientific data from various

groups, followed by discussions, in

order to improve understanding of

scientific issues that are the foundation

of regulatory guidelines. Breakout

sessions will address the following:

Adenoviral vectors, ancillary products,

facilities and manufacturing,

information on getting started in gene

therapy development, retroviral vectors,

pharmacology, toxicology, and the

development of new vector systems.

The information obtained from this

conference may assist in the

development of future scientific and

regulatory policy or guidance.

Dated: April 19, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–10484 Filed 4–26–96; 8:45 am]

BILLING CODE 4160–01–F

Health Resources and Services

Administration

Program Announcement and Proposed

Project Requirements and Review

Criteria for Cooperative Agreements

for Partnerships for Health Professions

Education for Fiscal Year 1996

The Health Resources and Services

Administration (HRSA) announces that

applications will be accepted for fiscal

year (FY) 1996 Cooperative Agreements

for Partnerships for Health Professions

Education. This model/demonstration

program will be jointly funded under

sections 738(b) (Minority Faculty

Fellowship Program), 739 (Centers of

Excellence in Minority Health

Professions Education), and 740 (Health

Careers Opportunity Program) of the

Public Health Service Act, as amended

by the Health Professions Education

Extension Amendments of 1992, Pub. L.

102–408, dated October 13, 1992. The

goal of this program is to establish and

test a comprehensive model program in

a geographically defined area (e.g.,

region, state, metropolitan or rural area),

that incorporates a variety of

educational and community-based

entities in a formal continuum of

activities to increase the number and

quality of: (1) Minority and

disadvantaged health professionals to

provide health services to underserved

populations and (2) minority faculty

serving in health professions schools.

No comprehensive model currently

exists.

Rationale

The rationale for conducting this

model project is to:

1. Test the feasibility and

effectiveness of executing a

comprehensive program in a defined

geographic area, which encompasses a

dynamic coordinated educational

continuum designed to increase the

number and quality of minority/

disadvantaged health professionals and

minority faculty for health professions

schools. This program includes formal

linkages among several communitybased entities and educational

institutions.

2. Compare performance outputs of a

comprehensive approach versus the

output of several independent projects

operating in a defined geographic area

as is currently practiced.

3. Assess the cost effectiveness of a

comprehensive model versus a multiple

independent projects approach (testing

the hypothesis that approximately one

third of the costs for personnel and

overhead expenditures would be saved

through a comprehensive administrative

infrastructure).

4. Determine the potential for several

community and educational entities

forming a unified, effective, multidimensional, comprehensive

educational continuum under the

umbrella of a single lead institution.

5. Test the relative soundness of a

cooperative comprehensive approach

versus that of several projects acting

independently. This would facilitate

tracking, monitoring and retaining

targeted individuals through the

educational pathway to become health

professionals and/or faculty in health

professions schools.

This program announcement is

subject to reauthorization of the

legislative authorities and to the

appropriation of funds. Applicants are

advised that this program

announcement is a contingency action

being taken to assure that should

authority and funds become available

for this purpose, they can be awarded in

a timely fashion consistent with the

needs of the program as well as to

provide for even distribution of funds

throughout the fiscal year. At this time,

given a continuing resolution and the

absence of FY 1996 appropriations for

title VII programs, the amount of

available funding for this specific

cooperative agreement cannot be

estimated.

Purpose

The purposes of this program are to:

(1) Assist schools in supporting

programs of excellence in health