18612 Federal Register / Vol. 61, No. 82 / Friday, April 26, 1996 / Notices

information, including the validity of

the methodology and assumptions used;

(3) ways to enhance the quality, utility,

and clarity of the information to be

collected; and (4) ways to minimize the

burden of the collection of information

on respondents, including the use of

automated collection techniques, when

appropriate, and other forms of

information technology.

Section 1701(a)(4) of the Public

Health Service Act (42 U.S.C.

300u(a)(4)) authorizes FDA to conduct

research relating to health information.

The Marketing Practices and

Communications Branch of FDA’s

Division of Drug Marketing,

Advertising, and Communications is

studying the effectiveness of various

formats for the presentation of risk and

benefit information for over-the-counter

(OTC) and prescription drugs to male

and female patients through patient

labeling. To gain information about the

value and utility of benefit and risk

information presented in several

formats, three studies will be

undertaken. In each study subjects will

examine materials varied by one or

more risk formatting variables for one

prescription and one OTC drug.

Subjects will be recruited at large

shopping malls. They will be brought to

a private interview room where they

will examine the materials, and a

structured interview will be conducted.

Equal numbers of subjects of each

gender will be included in each study.

In addition, there will be a control

group for each study that receives ‘‘norisk’’ information labels for the drugs.

There will be 2,160 experimental

subjects and 540 control subjects, for a

total of 2,700 respondents.

ESTIMATED ANNUAL REPORTING BURDEN

No. of respondents

Annual frequency per

response

Total annual

responses

Hours per

response Total hours

2,700 ................................................................................................................................. 1 1 .5 1,350

There are no capital costs or operating and maintenance costs associated with this collection.

Dated: April 19, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–10302 Filed 4–25–96; 8:45 am]

BILLING CODE 4610–01–M

[Docket No. 96D–0132]

Guidance Concerning Demonstration

of Comparability of Human Biological

Products; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a document entitled

‘‘FDA Guidance Concerning

Demonstration of Comparability of

Human Biological Products, Including

Therapeutic Biotechnology-derived

Products.’’ Manufacturing process,

equipment, and/or facilities changes

have the potential to alter a product and

affect its safety, identity, purity, and

potency. Therefore, manufacturers

should carefully assess such changes

and should evaluate the product

resulting from these changes for

comparability to the pre-existing

product. This guidance document is

intended to address the concept of

comparability and delineates those

analyses that manufacturers should

perform and which FDA will evaluate to

allow more rapid implementation of

manufacturing changes for these types

of products.

DATES: Written comments may be

submitted at any time, however, to

ensure comments are considered for the

next revision, they should be submitted

by July 25, 1996.

ADDRESSES: CBER Information: Submit

written requests for single copies of the

document entitled ‘‘FDA Guidance

Concerning Demonstration of

Comparability of Human Biological

Products, Including Therapeutic

Biotechnology-derived Products’’ to the

Division of Congressional and Public

Affairs (HFM–44), Center for Biologics

Evaluation and Research (CBER), Food

and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448. Send one self-addressed adhesive

label to assist that office in processing

your requests. The document may also

be obtained by FAX by calling the CBER

Voice Information System at 1–800–

835–4709. Persons with access to the

INTERNET may obtain the document in

several ways. Users of ‘‘Web Browser’’

software, such as Mosaic, Netscape, or

Microsoft Internet Explorer may obtain

this document via the World Wide Web

by using the following Uniform

Resource Locators (URL’s):http://

www.fda.gov/cber/cberftp.htmlftp://

ftp.fda.gov/CBER/

The document may also be obtained

via File Transfer Protocol (FTP).

Requesters should connect to the FDA

FTP Server, FTP.FDA.GOV

(192.73.61.21). The Center for Biologics

Evaluation and Research (CBER)

documents are maintained in a

subdirectory called ‘‘CBER’’ on the

server. Logins with the user name of

anonymous are permitted, and the

user’s e-mail address should be sent as

the password. The ‘‘READ.ME’’ file in

that subdirectory describes the available

documents which may be available as

an ASCII text file (*.TXT), or a

WordPerfect 5.1 or 6.x document

(*.w51,wp6), or both. Finally, the

document can be obtained by ‘‘bounceback e-mail’’. A message should be sent

to: ‘‘comptest@a1.cber.fda.gov’’.

CDER Information: For additional

copies of this guidance, contact the

Division of Communications

Management (HFD–210), Center for

Drug Evaluation and Research (CDER),

Food and Drug Administration, 5600

Fisher’s Lane, Rockville, MD 20857,

301–594–1012. Send one self-addressed

adhesive label to assist that office in

processing your requests. An electronic

version of this guidance is also available

via Internet using FTP, Gopher or the

World Wide Web (WWW). For FTP,

connect to the CDER anonymous FTP

server at cdvs2.cder.fda.gov and change

to the ‘‘guidance’’ directory. For Gopher,

connect to the CDER Gopher server at

gopher.cder.fda.gov and select the

‘‘Industry Guidance’’ menu option. For

WWW, connect to the FDA Home Page

at http://www.fda.gov./

fdahomepage.htlm.

Submit written comments on the

document to the Dockets Managements

Branch (HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

Corporations should submit two copies

of any comments and individuals may

submit one copy. Requests and

comments should be identified with the

docket number found in brackets in the

heading of this document. A copy of the

document and received comments are

available for public examination in the
Federal Register / Vol. 61, No. 82 / Friday, April 26, 1996 / Notices 18613

Dockets Management Branch between 9

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

Friday.

FOR FURTHER INFORMATION CONTACT:

Annette Ragosta, Center for Biologics

Evaluation and Research (HFM–630),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–594–3074.

SUPPLEMENTARY INFORMATION: FDA

acknowledges that changes in product

manufacture may occur during product

development and subsequent to product

approval. Manufacturers frequently

upgrade and refine a product’s

production process as technology

advances and as they gain experience

with the product. Historically, because

of the limited ability to characterize the

identity and structure of the clinically

active component(s) and measure its

activity, a biological product was often

defined by its manufacturing process,

and manufacturers of biological

products sought to minimize changes to

the manufacturing process to avoid

performing additional clinical studies to

verify the safety, purity, and potency of

the finished product. Due to advances in

biologics research and manufacturing,

including the ability to make wellcharacterized biotechnology-derived

products, a manufacturer may change a

manufacturing process without FDA

requiring additional clinical studies if

test data demonstrate that the product is

comparable to the product

manufactured before the change.

Therefore, FDA is publishing this

guidance document to further clarify

situations in which sponsors may make

manufacturing changes and perform

comparability testing to assure that the

approved product is pure, potent, and

safe.

Manufacturers should perform

comparability testing to demonstrate

that identity, purity, potency, and safety

of the product have not been affected by

changes in the manufacturing process,

equipment, or facilities. This guidance

document discusses principles and

categories of tests which may be

performed to demonstrate product

comparability, but does not discuss

specific manufacturing changes.

Comparability testing programs may

include a combination of analytical

testing, bioassays, preclinical animal

studies, and clinical studies. Since each

product may present unique concerns,

the type of change, the relevance of

validated analytical and biological

assays used, the stage of product

development, and the clinical program

should be considered by manufacturers

when designing a comparability

program. FDA will take all of these into

consideration when reviewing the

comparability data that are submitted.

Sponsors are encouraged to discuss

proposed testing programs with FDA

before implementing them, especially in

those cases where they expect

differences to result from the

manufacturing changes. This document

does not describe how changes are to be

reported or which changes require prior

approval. Manufacturers should consult

current regulations and guidance

documents regarding reporting and

approval submissions.

As with other guidance documents,

FDA does not intend this document to

be all inclusive. The document is

intended to provide information and

does not set forth requirements.

Manufacturers may follow the

document or may choose to use

alternative procedures that are not

provided in this document. If a

manufacturer chooses to use alternative

procedures, that manufacturer may wish

to discuss the matter further with FDA

to prevent expenditure of resources to

generate data on activities that FDA may

later determine to be unacceptable.

Although this guidance document

does not create or confer any rights for

or on any person and does not operate

to bind FDA or the public, it does

represent the agency’s current thinking

on the demonstration of comparability

of human biological products, including

therapeutic biotechnology-derived

products.

Interested persons may submit to the

Dockets Management Branch (address

above) written comments on the

guidance document. FDA will review

the comments received and if

appropriate consider preparing a revised

guidance document based upon that

review. However, CBER notes that it has

made comparability assessments when

approving /products in the past and will

continue to do so during the comment

period. FDA will announce the

availability of this revised guidance

document in the Federal Register if

FDA revises its comparability policy as

a result of public comment.

Dated: April 22, 1996

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–10426 Filed 4–25–96; 8:45 am]

BILLING CODE 4160–01–F

Health Resources and Services

Administration

Maternal and Child Health Services;

Federal Set-Aside Program;

Continuing Education and

Development Cooperative Agreements

AGENCY: Health Resources and Services

Administration (HRSA), PHS.

ACTION: Notice of availability of funds.

SUMMARY: The HRSA announces that

applications will be accepted for fiscal

year (FY) 1996 funds for Maternal and

Child Health (MCH) Special Projects of

Regional and National Significance

(SPRANS) Continuing Education and

Development (CED) cooperative

agreements to support national

education, information, and public

policy projects in maternal and child

health. Awards will be made under the

program authority of section

502(a)(2)(A) of the Social Security Act,

the training provision of the MCH

Federal Set-Aside Program. SPRANS

training projects may be awarded only

to public or nonprofit private

institutions of higher learning. Within

the HRSA, MCH CED cooperative

agreements are administered by the

Maternal and Child Health Bureau

(MCHB). Awards under this

announcement are made for grant

periods of up to 5 years in duration.

This program announcement is

subject to the appropriation of funds.

Applicants are advised that this

program announcement is a contingency

action being taken to assure that should

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 the

SPRANS program, the amount of

available funding for this specific grant

program cannot be estimated.

The Public Health Service (PHS) is

committed to achieving the health

promotion and disease prevention

objectives of Healthy People 2000, a

PHS-led national activity for setting

priority areas. The MCH Block Grant

Federal Set-Aside Program addresses

issues related to the Healthy People

2000 objectives of improving maternal,

infant, child and adolescent health and

developing service systems for children

with special health care needs. 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