63048 Federal Register / Vol. 60, No. 236 / Friday, December 8, 1995 / Notices

the Substance Abuse and Mental Health

Services Administration (SAMHSA)

National Advisory Council in January

1996.

The meeting of the SAMHSA National

Advisory Council will include

discussions concerning SAMHSA’s

Reauthorization; update on SAMHSA’s

demonstration program; SAMHSA’s

Managed Care Initiative, including the

role of SAMHSA in developing mental

health and substance abuse standards

for managed care facilities; report on the

Performance Partnership Development

Process and Regional Meetings; and a

report on the Co-Occurring Meeting. In

addition various constituency

organizations will be describing their

collaborative efforts around the

development of performance measures

and outcomes monitoring, and

exemplary community based programs

will be describing their efforts to

prevent and treat mental and addictive

disorders. Finally, there will be status

reports by the Council’s work groups on

Health Care Reform and Children’s

Services. Attendance by the public will

be limited to space available.

The meeting will also include the

review, discussion and evaluation of

contract proposals. Therefore a portion

of the meeting will be closed to the

public as determined by the

Administrator, SAMHSA, in accordance

with Title 5 U.S.C. 552b(c) (3), (4) and

(6) and 5 U.S.C. app. 2 10(d).

A summary of the meeting and a

roster of Council members may be

obtained from: Ms. Susan E. Day,

Program Assistant, SAMHSA National

Advisory Council, 5600 Fishers Lane,

Room 12C–15, Rockville, Maryland

20857. Telephone: (301) 443–4640.

Substantive program information may

be obtained from the contact whose

name and telephone number is listed

below.

Committee Name: Substance Abuse and

Mental Health Services Administration,

National Advisory Council.

Meeting Date: January 22, 1996.

Place: Omni-Shoreham Hotel, 2500 Calvert

Street, N.W., Washington, DC 20008.

Open: January 22, 1996, 9:00 a.m. to 4:30

p.m.

Closed: January 22, 1996, 5:00 p.m. to 6:00

p.m.

Contact: Toian Vaughn, Room 12C–15,

Parklawn Building, telephone (301) 443–

4640 and FAX (301) 443–1450.

Dated: December 4, 1995.

Jeri Lipov,

Committee Management Officer, Substance

Abuse and Mental Health Services

Administration.

[FR Doc. 95–29934 Filed 12–7–95; 8:45 am]

BILLING CODE 4162–20–P

Food and Drug Administration

[Docket No. 95N–0371]

Interim Definition and Elimination of

Lot-by-Lot Release For WellCharacterized Therapeutic

Recombinant DNA-Derived and

Monoclonal Antibody Biotechnology

Products

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

interim definition for well-characterized

therapeutic recombinant DNA-derived

and monoclonal antibody biotechnology

products. FDA is also announcing that

FDA is eliminating lot-by-lot release for

licensed well-characterized therapeutic

recombinant DNA-derived and

monoclonal antibody biotechnology

products. After approval, manufacturers

of such products are no longer requested

to submit samples and protocols for

individual lots of products to the Center

for Biologics Evaluation and Research

(CBER) for routine lot-by-lot release.

Manufacturers may begin distributing

products affected by this policy after

notification by CBER and without

awaiting approval of a supplement to

their product license applications. This

notice is intended to reduce

unnecessary burdens for industry

without diminishing public health

protection.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

Comments should be identified with the

docket number found in brackets in the

heading of this document. Two copies

of any comments are to be submitted,

except that individuals may submit one

copy. 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:

Regarding lot release: Jerome A.

Donlon, Center for Biologics

Evaluation and Research (HFM–

200), Food and Drug

Administration, 1401 Rockville

Pike, Rockville, MD 20852–1448,

301–594–2200.

Regarding the definition of a wellcharacterized therapeutic

recombinant DNA-derived and

monoclonal antibody biotechnology

product: Jean M. Olson, Center for

Biologics Evaluation and Research

(HFM–630), Food and Drug

Administration, 1401 Rockville

Pike, Rockville, MD 20852–1448,

301–594–3074.

SUPPLEMENTARY INFORMATION: This

notice is being issued in accordance

with the principles set forth in

Executive Order 12866. Executive Order

12866 directs Federal agencies to

implement measures that will reform

and streamline the regulatory process to

avoid unnecessary regulatory burdens.

In the November 1995 ‘‘Reinventing the

Regulation of Drugs Made from

Biotechnology’’ report, the President

and Vice President announced a series

of regulatory reform initiatives,

including FDA’s intention to issue a

notice eliminating lot-by-lot release for

licensed well-characterized therapeutic

recombinant DNA-derived and

monoclonal antibody biotechnology

products. FDA made a commitment to

issue the notice within 30 days of the

report.

Elimination of Lot-by-Lot Release

Biologics have traditionally been

complex mixtures of substances

produced primarily from living

organisms, and have been difficult to

characterize by precise tests. They

include vaccines, products made from

human or animal blood, and other

products made from a variety of

materials. Because of the inherent

variability of these products, each

individual lot of most biological

products has been subject to evaluation

and testing by CBER prior to release.

Under § 610.2 (21 CFR 610.2), the

Director of CBER may require, at any

time, that samples of a licensed product,

protocols, and test results be submitted

to CBER for official release. FDA has

invoked lot-by-lot release to help ensure

that products continue to meet

established standards before they are

distributed.

Historically, lot-by-lot release has

served an important role in the

regulation of biotechnology products

and has prevented the distribution of

unacceptable lots. However, greater

control has been achieved by

manufacturers over the production of

biotechnology products through inprocess controls, process validation, and

advances in analytical techniques. For

well-characterized therapeutic

recombinant DNA-derived and

monoclonal antibody biotechnology

products, as defined below, FDA has

found that once a company has

demonstrated its ability to consistently

produce acceptable lots, and has

procedures in place that will prevent

the release of lots that do not meet

release specifications, it is not necessary

for FDA to verify that each
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