Federal Register / Vol. 60, No. 236 / Friday, December 8, 1995 / Notices 63049

manufactured lot is acceptable for

release.

Accordingly, as provided under

§ 610.2, the Director of CBER is no

longer requiring that manufacturers of

well-characterized therapeutic

recombinant DNA-derived and

monoclonal antibody biotechnology

products submit samples and protocols

to CBER. FDA will continue to monitor

companies’ compliance with the

requirement in § 610.1 ( 21 CFR 610.1)

that they assay each lot and release only

those lots that meet release

specifications.

FDA intends to revise the guidance

entitled, ‘‘Guidance on Alternatives to

Lot Release for Licensed Biological

Products,’’ (58 FR 38771, July 20, 1993)

to reflect the new procedures.

Manufacturers who do not receive a

letter, but think that one of their

licensed products meets the interim

definition, may contact Jerome A.

Donlon (address above).

Eliminating FDA lot-by-lot release

should not compromise the safety,

purity, or potency of licensed wellcharacterized therapeutic recombinant

DNA-derived and monoclonal antibody

biotechnology products. Because of

process validation and current inprocess controls and testing for these

products, identity, purity, and potency

can be controlled and measured. In

addition, the in-process and endproduct release specifications can be

validated for these products. Therefore,

submission of lot release samples and

protocols are no longer viewed by FDA

as essential to the ongoing assurance of

safety for these products.

Eliminating lot-by-lot release for these

products furthers FDA’s harmonization

of its regulation of well-characterized

therapeutic recombinant DNA-derived

and monoclonal antibody biotechnology

products between CBER and the Center

for Drug Evaluation and Research.

Manufacturers are still required under

§ 610.1 to test each lot and release only

those that meet release specifications.

During inspections, FDA will monitor

compliance with those requirements.

Manufacturers continue to be required

to maintain adequate records and

retention samples under 21 CFR 211.170

and 211.180.

Interim Definition

FDA has prepared the following

interim definition for a wellcharacterized therapeutic recombinant

DNA-derived and monoclonal antibody

biotechnology product:

A chemical entity(ies) whose identity,

purity, impurities, potency, and quantity can

be determined and controlled.

Identity:

a. Recombinant DNA Biotechnology

Products

The primary structure is known (i.e.,

amino acid sequence), and

The secondary structure is known (e.g.,

disulfide linkage), and

Post-translational modifications are known

(e.g., glycosylation), or

b. Monoclonal Antibodies

The identity can be determined by rigorous

physicochemical and immunochemical

characterization without fully knowing its

chemical structure.

Purity and impurities:

The purity is quantifiable.

The impurities are quantifiable, and

identified if feasible.

Potency and quantity:

The biological activity is measurable.

The quantity is measurable.

Well-characterized therapeutic

recombinant DNA-derived or

monoclonal antibody biotechnology

products require proper raw material

controls, process validation and

controls, and sensitive and validated

test methods and specifications. FDA

intends to use the definition to

determine which products may be

exempted from lot-by-lot release and to

help determine which products may be

eligible for other regulatory initiatives

directed at well-characterized

biotechnology products.

FDA invites comments on its

proposed definition for wellcharacterized therapeutic recombinant

DNA-derived and monoclonal antibody

biotechnology products. In particular,

FDA invites comments on whether the

proposed definition for wellcharacterized therapeutic recombinant

DNA-derived and monoclonal antibody

biotechnology products should be

expanded to include other categories of

products that would be considered to be

well-characterized and should be

categorically exempted from lot-by-lot

release.

In the Federal Register of October 25,

1995 (60 FR 54695), FDA announced

that it is sponsoring a public scientific

workshop on December 11 through 13,

1995. At the workshop participants will

be asked to refine the definition of a

well-characterized therapeutic

recombinant DNA-derived and

monoclonal antibody biotechnology

product as set forth above. After

considering the information presented

at the workshop, FDA may modify the

interim definition given above.

Manufacturers of well-characterized

therapeutic recombinant DNA-derived

and monoclonal antibody biotechnology

products affected by this change in

policy will be notified by letter.

CBER does not intend for this notice

to be comprehensive. If a manufacturer

has questions concerning application of

this policy to one of its licensed

products or the interim definition, it can

discuss the matter with CBER. Although

the interim definition for wellcharacterized therapeutic recombinant

DNA-derived and monoclonal antibody

biotechnology products in this notice is

not binding on either FDA or

manufacturers of biological products

and does not create or confer any rights

for or on any person, it does represent

the agency’s current thinking on that

definition.

Dated: December 4, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95–29960 Filed 12–5–95; 2:43 pm]

BILLING CODE 4160–01–F

[Docket No. 93N–371W]

Prescription Drug Product Labeling;

Public Patient Education Workshop

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of a public workshop.

SUMMARY: The Food and Drug

Administration (FDA) is announcing a

public patient education workshop to

discuss methods and criteria for

developing and evaluating prescription

drug information for patients. The

purpose of this workshop is to obtain

views and opinions concerning the

criteria for useful patient information,

and is part of FDA’s ongoing initiative

to improve the distribution of adequate

and useful prescription drug

information to patients. FDA encourages

health professionals, consumer groups,

industry, academicians, other experts in

the field, and interested parties to

participate in the workshop. FDA also

invites the designers of primary

information systems, which produce

either written information or computer

programs that generate prescription

drug patient information, to display

their systems for educational purposes.

DATES: The public patient education

workshop will be held on January 9 and

10, 1996, from 8:30 a.m. to 5 p.m.

Submit registration notices for

participants by December 26, 1995.

Submit registration notices for designers

of information systems by December 19,

1995. Submit written comments by

January 31, 1996.

ADDRESSES: The public patient

education workshop will be held at the

National Institutes of Health, Natcher

Auditorium, 9000 Rockville Pike,

Rockville, MD. Pre-registration for

workshop participants is encouraged,

although not required, in order to

facilitate logistical planning of the
63050 Federal Register / Vol. 60, No. 236 / Friday, December 8, 1995 / Notices

breakout discussion groups. There is no

registration fee for this workshop.

Registration forms can be obtained by

calling 301–443–5470 or writing to the

Office of Health Affairs, ATTN: Patient

Education Workshop, Food and Drug

Administration (HFY–40), 5600 Fishers

Lane, Rockville, MD 20857. Submit

written views or comments to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857. The designers of

information systems should call the

contact person (address below) for

registration information. A more

detailed agenda and written

presentations will be placed in the

docket, identified with the docket

number found in brackets in the

heading of this document, at the

Dockets Management Branch, and will

be available for review between 9 a.m.

and 4 p.m., Monday through Friday. A

transcript of the general sessions of the

workshop will be available for review or

purchase (10 cents per page) at the

Dockets Management Branch

approximately 5 business days after the

meeting. The breakout sessions will not

be transcribed.

FOR FURTHER INFORMATION CONTACT:

Thomas J. McGinnis, Office of Health

Affairs (HFY–40), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–5470.

SUPPLEMENTARY INFORMATION: In the

Federal Register of August 24, 1995 (60

FR 44182), FDA published a proposed

rule which, if finalized, is intended to

increase the dissemination of useful

written prescription drug information to

patients who receive prescription drugs

on an outpatient basis. The agency

believes that such information must be

widely distributed and be of sufficient

quality to promote the proper use of

prescription drugs. The agency

proposed goals (performance standards)

that would define acceptable levels of

information distribution and quality. To

meet the performance standard for

distribution of patient information, the

agency proposed that by the year 2000,

at least 75 percent of people receiving

new prescriptions receive useful written

information. This goal was adapted from

the Public Health Service’s ‘‘Healthy

People 2000’’ report. In addition, the

agency proposed that by the year 2006,

at least 95 percent of the people who

receive new prescriptions receive useful

written information.

FDA proposed to periodically

evaluate and report on the achievement

of the goals. If the goals are not met in

the specified timeframes, FDA proposed

to either: (1) Implement a mandatory

comprehensive medication guide

program, or (2) seek public comment on

whether the comprehensive program

should be implemented, or whether,

and what, other steps should be taken

to meet the patient information goals.

In the Federal Register of August 24,

1995, the agency proposed the following

seven specific components for

determining whether patient

information is useful: Scientific

accuracy, consistency with a standard

format, nonpromotional tone and

content, specificity, comprehensiveness,

understandable language, and legibility.

The agency defined these components

of usefulness, as well as criteria that

could be used to judge these

components, and invited comments on

their appropriateness. The agency also

stated that it would hold a public

meeting for interested parties to provide

recommendations and rationale for

evaluating usefulness of written

information.

The agency will hold a public patient

education workshop to discuss the

methods and criteria for developing and

evaluating the usefulness of written

information. The patient education

workshop will be designed to obtain

recommendations from the public about

the criteria that should be applied to

help ensure that written information

provided to patients is ‘‘useful.’’

The patient education workshop will

be comprised of both formal

presentations and open breakout

discussion periods. Any interested

person may attend and participate in the

discussions. The workshop will include

general sessions with presentations from

FDA, health professional groups,

consumer groups, the pharmaceutical

industry, academicians, and parties

with legal and regulatory expertise. The

agency also intends to hold breakout

sessions throughout the 2-day workshop

to obtain broad participation and input

from workshop attendees.

FDA believes that it would be helpful

for workshop participants (including

FDA staff) to learn about the design of

current patient information systems, in

particular, programs that generate drugspecific patient information. The agency

invites the designers of primary

information systems (not the

customizers of systems for retail outlets)

to display their systems at the workshop

for educational purposes only. No sales

or solicitations may be made by

exhibitors at the workshop site. Due to

space limitations, FDA may be forced to

limit the number of systems on display.

In doing so, FDA would seek to permit

display of the most representative/

comprehensive systems available for

patient information. However, the

agency invites all interested persons to

submit their views, comments, and

descriptions of computer programs to

the Dockets Management Branch

(address above).

The agency notes that the comment

period for the proposed rule that

published in the Federal Register of

August 24, 1995, has recently been

extended until December 22, 1995 (60

FR 58025, November 24, 1995). Because

this workshop will occur after the

comment period has closed, the agency

will accept additional comments to the

proposed rule on the specific issues

raised at the workshop. These

comments will be considered as part of

the agency’s deliberations regarding

further action on this rulemaking. For

this limited purpose, written comments

may be submitted to the Dockets

Management Branch (address above)

until January 31, 1996. Comments are to

be identified with the docket number

found in brackets in the heading of this

document.

A summary of the workshop will be

included in a subsequent Federal

Register notice related to this

prescription drug labeling initiative.

Dated: December 1, 1995.

William K. Hubbard,

Associate Commissioner for Policy.

[FR Doc. 95–29903 Filed 12–7–95; 8:45 am]

BILLING CODE 4160–01–F

National Institutes of Health

National Institute of Mental Health;

Notice of Closed Meeting

Pursuant to Section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following meeting

of the National Institute of Mental

Health Special Emphasis Panel:

Agenda/Purpose: To review and evaluate

grant applications.

Committee Name: National Institute of

Mental Health Special Emphasis Panel.

Date: December 11, 1995.

Time: 11 a.m.

Place: Parklawn Building, Room 9C–18,

5600 Fishers Lane, Rockville, MD 20857.

Contact Person: Michael D. Hirsch,

Parklawn Building, Room 9C–18, 5600

Fishers Lane, Rockville, MD 20857,

Telephone: (301) 443–1000.

The meeting will be closed in accordance

with the provisions set forth in secs.

552b(c)(4) and 552b(c)(6), Title 5, U.S.C.

Applications and/or proposals and the

discussions could reveal confidential trade

secrets or commercial property such as

patentable material and personal information

concerning individuals associated with the

applications and/or proposals, the disclosure

of which would constitute a clearly

unwarranted invasion of personal privacy.