2166 Federal Register / Vol. 62, No. 10 / Wednesday, January 15, 1997 / Notices

FOR FURTHER INFORMATION CONTACT:

Naba K. Das, Center for Veterinary

Medicine (HFV–133), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1659.

SUPPLEMENTARY INFORMATION: The use of

clorsulon suspension in goats is a new

animal drug use under section 201(v) of

the Federal Food, Drug, and Cosmetic

Act (the act) (21 U.S.C. 321(v)). As a

new animal drug, clorsulon suspension

is subject to section 512 of the act (21

U.S.C. 360b), which requires that its use

in goats be the subject of an approved

NADA or supplemental NADA. Goats

are a minor specie under

§ 514.1(d)(1)(ii) (21 CFR 514.1(d)(1)(ii)).

The NRSP–7 Project, Southern

Region, University of Florida,

Gainesville, FL 32610, has filed data

and information that demonstrate safety

and effectiveness to goats orally

drenched with a suspension containing

8.5 percent of clorsulon for the

treatment of adult liver fluke (Fasciola

hepatica) infestation. NRSP–7 has also

filed human food safety data and an

environmental assessment that

adequately addresses the potential

impacts due to use of the drug product.

The data and information are

contained in PMF 5440. Sponsors of

NADA’s or supplemental NADA’s may,

without further authorization, refer to

the PMF to support approval of an

application filed under § 514.1(d). An

NADA or supplemental NADA must

include, in addition to reference to the

PMF, animal drug labeling and other

data needed for approval, such as

manufacturing methods, facilities, and

controls, and information addressing the

potential environmental impacts

(including occupational) of the

manufacturing process. Persons desiring

more information concerning the PMF

or requirements for approval of an

NADA may contact Naba K. Das

(address above).

In accordance with the freedom of

information provisions of 21 CFR part

20 and 514.11(e)(2)(ii), a summary of

target animal safety, effectiveness, and

human safety data and information

provided in this PMF to support

approval of an application may be seen

in the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857, between

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

Friday.

Dated: January 6, 1997.

Michael J. Blackwell,

Deputy Director, Center for Veterinary

Medicine.

[FR Doc. 97–1022 Filed 1–14–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 96N–0478]

Cancer-Related Advisory Committees;

Proposed Process for Selection of

Patient Representatives

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is requesting

comments from interested parties on the

proposed process for the selection of

patient representatives to serve on

cancer-related advisory committees. As

part of the ‘‘FDA Initiative on

Reinventing the Regulation of Cancer

Drugs,’’ the Cancer Liaison Staff in the

Office of AIDS and Special Health

Issues has been charged with

developing a process for recruitment,

assessment, and selection of patient

representatives to serve as members of

cancer-related advisory committees in

the Center for Drug Evaluation and

Research (CDER), the Center for

Biologics Evaluation and Research

(CBER), and the Center for Devices and

Radiological Health (CDRH). This

initiative is intended to provide

representation for cancer patients and to

ensure that the selection process will

provide for broad representation in the

nominee pool, and to develop criteria

for the selection of the patient

representatives. The criteria for both the

nomination and selection process will

help ensure that the patient

representative will provide the

perspective of the patients with the

disease for which a therapeutic product

is being considered by the advisory

committee.

DATES: Written comments on the

proposed process by March 17, 1997.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

JoAnn Minor, Office of AIDS and

Special Health Issues (HF–12), Food and

Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–827–

4460 or E-mail: JMinor@bangate.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

On March 29, 1996, President Clinton

announced the ‘‘FDA Initiative on

Reinventing the Regulation of Cancer

Drugs’’ that will result in more rapid

approval of cancer therapies and

expanded access to investigational

cancer therapies. This program of cancer

initiatives also includes the

participation of patient representatives

on FDA advisory committees that

review and consider cancer-related

therapies. Advisory committees provide

independent, outside expert scientific

advice to the agency; they evaluate data

concerning the safety and efficacy of

products and make recommendations to

the agency concerning their approval

and appropriate use.

Patient representatives can provide a

unique perspective during the

deliberations of advisory committees.

The patient representatives bring to the

committee the views on the drug or

product under review from individuals

and families directly affected by the

disease. The agency recognizes the

valuable contributions that patient

representatives provide. During the past

several years, the Antiviral Drugs

Advisory Committee and the Blood

Products Advisory Committee have

included patient representatives at their

meetings when products for the

treatment or diagnosis of human

immunodeficiency virus/acquired

immune deficiency syndrome (HIV/

AIDS) and blood safety were under

discussion. More recently, the

Oncologic Drugs Advisory Committee,

the Biological Response Modifiers

Advisory Committee, and the Medical

Imaging Drugs Advisory Committee

have begun including such

representatives.

Patients, patient advocacy groups, and

others have endorsed the agency in its

commitment to include patient

representation on advisory committees.

In the past, the medical review division

and the advisory committee’s Executive

Secretary, acting upon

recommendations by the Office of AIDS

and Special Health Issues, selected

patient representatives through an

informal process. The agency believes

that it would be useful to have a

uniform system to recruit, select, and

refer patient representatives to serve on

FDA advisory committees. The

following is a proposed process to

formalize the recruitment and selection

of patient representatives to serve on

committees reviewing cancer-related

therapies.

II. The Proposed Process

The agency is developing a process

for the recruitment, assessment,

selection, and training of patient

representatives. As part of this process,

the agency believes that a mechanism

for soliciting nominations of qualified

patient representatives to ensure broad

representation in the nominee pool is

critical. To that end, the agency

proposes to develop: (1) A listing of

qualifications to be considered in
Federal Register / Vol. 62, No. 10 / Wednesday, January 15, 1997 / Notices 2167

selecting patient representatives, and (2)

a plan for soliciting nominations.

A. Qualifications for Patient

Representatives

The agency has decided that patient

representatives on FDA advisory

committees that review and consider

cancer therapies will be voting

members. Patient representatives will be

subject to the same conflict of interest

requirements as other committee

members as set out in § 14.80 (21 CFR

14.80) and must serve as special

Government employees. Section 14.80

defines the qualifications for voting

members of advisory committees. FDA

recognizes that in some cases the

composition of an advisory committee is

mandated by statute or regulation. The

agency will make a determination to

add a voting patient representative on a

case-by-case basis when: (1) Meetings

are planned; (2) FDA determines it is

allowable within the statutes and

regulations; and (3) it is feasible and

beneficial to a committee’s deliberation.

The primary role of the patient

representative would be to provide to

the advisory committee the perspective

of the patients with the disease for

which the therapeutic agent is being

considered. Currently, many of the FDA

advisory committees, including those

that provide advice on cancer-related

issues, include a representative who is

broadly identified with consumer

interests and who has been nominated

and recommended by a consumeroriented organization. However, because

there are so many different cancers, the

number of appropriate perspectives is

larger than a single consumer can

represent. To more specifically

represent the interests of the patients,

the FDA believes that a patient

representative who understands issues

specific to the cancer for which a drug,

device, or biologic approval is being

sought would bring valuable insights to

the FDA advisory committee process.

Multiple factors are important to

determine the ability of a person to be

an effective patient representative. In

addition to the qualifications described

under § 14.80, the following

qualifications are under consideration

for selecting patient representatives: (1)

Personal experience with an illness,

condition, or treatment; (2) experience

as a patient advocate; (3) formal

affiliation with a patient advocacy

organization; (4) ability to articulate the

perspective of the patient; (5) ability to

identify issues through communications

with patient constituencies; (6) ability to

access mechanisms to disseminate

information from an advisory committee

meeting to the affected community; and

(7) experience in technical issues before

the committee.

B. Soliciting Nominations

The agency believes that a mechanism

for soliciting nominations of qualified

patient representatives to ensure broad

representation in the nominee pool is

critical. After the qualifications for

voting patient representatives are

defined, the agency proposes to solicit

nominations by the following methods:

(1) Federal Register announcement as

set out in 21 CFR 14.82; and possibly

through Internet announcements; (2)

direct mailings of announcements and

personalized letters to patient advocacy

groups, community organizations, and

other public interest organizations; (3)

patient newsletter announcements; or

(4) display announcements at

conferences, advisory committee

meetings, workshops, etc. that FDA staff

members attend, and at other

conferences, meetings, and workshops.

Nominations may be submitted by

individuals, patient advocacy groups

and organizations. Self nominations will

also be acceptable.

III. Comments

FDA is seeking the views of the public

with regard to the proposed

qualifications that should be considered

in selecting a patient representative and

comments on the adequacy of the

methods proposed to obtain

nominations. The agency will review

and consider written comments on the

approach set forth in this notice. Any

comments received will be considered

in determining whether amendments to,

or revisions of, the approach are

warranted. Two copies of any comments

should be submitted, except that

individuals may submit one copy.

Comments are to be identified with the

docket number found in the brackets in

the heading of this document.

Comments received are available for

public examination in the Dockets

Management Branch (address above)

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

through Friday.

Dated: December 30, 1996.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–945 Filed 1–14–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 97N–0002]

Policy on Period of Marketing

Exclusivity for Newly Approved Drug

Products With Enantiomer Active

Ingredients; Request for Comments

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is reevaluating its

policy on the appropriate period of

marketing exclusivity for newly

approved drug products whose active

ingredient is a single enantiomer of a

previously approved racemate. This

action is being taken to assess incentives

for the development of new enantiomer

drug products that may represent

significant pharmaceutic advances. The

agency is requesting comments on this

issue and intends to publish a notice in

Federal Register at a later date

announcing its policy.

DATES: Written comments by March 17,

1997.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Wayne H. Mitchell, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–594–

1049.

SUPPLEMENTARY INFORMATION: FDA is

requesting comments on the agency’s

policy on marketing exclusivity for drug

products whose active ingredient is a

single enantiomer of a previously

approved racemate.

I. Enantiomers and Racemates

Stereoisomers are molecules that have

the same constitution (i.e., molecular

formula and chemical connectivity), but

differ in the spatial orientation of the

atoms. When two stereoisomers are

mirror images, but are not

superimposable upon each other (like

left and right hands), they are referred

to as enantiomers. Enantiomeric

molecules are identical in all physical

and chemical properties, except in an

environment which is also chiral

(characterized by handedness).

Polarized light is such an environment,

and pairs of enantiomers rotate the

plane of polarization by equal amounts

in opposite directions. Enantiomers may

be either right-handed (dextro-rotary)

S(+)-isomers or left-handed (levo-rotary)

R(-)-isomers. Racemates are equimolar

mixtures of enantiomers of the same

molecule.