Federal Register / Vol. 61, No. 82 / Friday, April 26, 1996 / Notices 18611

is Greensboro, North Carolina. The populations consist primarily of African-Americans. Health care providers will be

identified and solicited from practicing physicians in Raleigh and Greensboro.

The survey will be conducted in four phases. Phase I will randomly identify and solicit participation from household

members with and without diabetes from the control and intervention communities. In Phase II, participants with and

without diabetes will be randomly selected and administered the survey questionnaire upon granting informed consent.

During Phase III, persons with diabetes will undergo a brief physical exam that will consist of physical measures

for height, weight, blood pressure, and body mass index. In addition, collection of a venous blood sample and urine

sample will be performed. In Phase IV, interviewers will administer a questionnaire to primary care physicians about

their knowledge, attitude and practice patterns for caring for persons with diabetes. This study will undergo Institutional

Review Board reviews and comply with human subject assurances in accordance with federal regulations. The total

cost to respondents is estimated at $41,160.

Respondents No. of respondents

No. of responses/respondent

Avg. burden/response

(in hrs.)

Total

burden

(in hrs.)

Households ....................................................................................................................... 8,000 1 0.3333 2,666

Persons without diabetes ................................................................................................. 1,600 1 0.5 800

Persons with diabetes ...................................................................................................... 600 1 0.5 300

Primary Care Physicians .................................................................................................. 140 1 0.5 70

Total ....................................................................................................................... .................... .................... .................... 3,836

6. National Disease Surveillance Program I—(0920–0009)—Extension—Formal surveillance of 21 separate reportable

diseases has been ongoing to meet the public demand and scientific interest for accurate, consistent epidemiologic

data. The diseases include: HIV/AIDS, bacterial meningitis, dengue, idiopathic CD4+ T-lymphocytopenia, kawasaki syndrome, legionellosis, Hansen’s Disease, lyme disease, malaria, pertussis, plague, poliomyelitis, psittacosis, Reye Syndrome,

Rocky Mountain Spotted Fever, Tetanus, Toxic Shock Syndrome, toxocariasis, trichinosis, typhoid fever, and viral hepatitis.

Case report forms enable CDC to collect demographic, clinical, and laboratory characteristics of cases of these diseases.

This information is used to direct epidemiologic investigations, to identify and monitor trends in reemerging infectious

diseases or emerging modes of transmission, to search for possible causes or sources of the diseases, and to develop

guidelines for prevention and or treatment. It is also used to recommend target areas in most need of vaccinations

for certain diseases and to determine development of drug resistance.

Because of the distinct nature of each of the diseases, the number of cases reported annually is different for each.

The total cost to respondents is estimated at $818,184.

Respondents No. of respondents

No. of responses/respondentAvg. burden

response

(in hrs.)

Total

burden

(in hrs.)

Health Care Workers ........................................................................................................ 125,214 1 0.5 34,091

Total ....................................................................................................................... .................... .................... .................... 34,091

Dated: April 22, 1996.

Wilma G. Johnson,

Acting Associate Director for Policy Planning

and Evaluation, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 96–10356 Filed 4–25–96; 8:45 am]

BILLING CODE 4163–18–P

Food and Drug Administration

[Docket No. 96N–0010]

Agency Information Collection

Activities; Proposed Collection;

Comment Request

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

opportunity for public comment on the

proposed collection of certain

information by the agency. Under the

Paperwork Reduction Act of 1995,

Federal agencies are required to publish

notice in the Federal Register

concerning each collection of

information and to allow 60 days for

public comment in response to the

notice. This notice solicits comments on

a survey of male and female consumers

regarding various formats for presenting

risk and benefit information in drug

labeling.

DATES: Submit written comments by

June 25, 1996.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857. All

comments should be identified with the

docket number found in brackets in the

heading of this document.

FOR FURTHER INFORMATION CONTACT:

Charity B. Smith, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, rm. 16B–19, Rockville,

MD 20857, 301–827–1686.

SUPPLEMENTARY INFORMATION: Section

3506(c)(2)(A) of the Paperwork

Reduction Act of 1995 (44 U.S.C.

3506(c)(2)(A)) requires Federal agencies

to provide 60-day notice in the Federal

Register concerning each proposed

collection of information. ‘‘Collection of

information’’ is defined in 44 U.S.C.

3502(3) and 5 CFR 1320.3(c). To comply

with this requirement, FDA is

publishing notice of the proposed

collection of information listed below.

With respect to the following

collection of information, FDA invites

comments on: (1) Whether the proposed

collection of information is necessary

for the proper performance of FDA’s

functions, including whether the

information will have practical utility;

(2) the accuracy of FDA’s estimate of the

burden of the proposed collection of
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