66912 Federal Register / Vol. 66, No. 248 / Thursday, December 27, 2001 / Notices

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

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 through the

use of automated collection techniques,

when appropriate, and other forms of

information technology.

Title: Assessment of the Effects of

Antimicrobial Drug Residues from Food

of Animal Origin on the Human

Intestinal Flora

Description: Sponsors of new animal

drugs must meet certain statutory

requirements for new animal drug

approval under section 512 of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 360b). Among other things,

the sponsor must demonstrate that the

use of the drug is safe. Thus, when CVM

reviews new animal drug applications

for drugs that will be used in foodproducing animals, it must determine

whether residues of the drug that may

remain in human food derived from

those animals would be harmful to

humans. One possible harmful effect of

residues of antimicrobial drugs that

CVM considers in this determination is

the possible effect of residues on human

intestinal flora.

This draft guidance document

describes the recommended pathway

approach for assessing such effects. An

assessment of the safety of antimicrobial

drug residues in food is a major issue

that should be addressed by the sponsor

of a new animal drug. For residues

determined to have no antimicrobial

activity against representatives of the

human intestinal flora, an ADI should

be calculated based on traditional

toxicology studies. The burden hours

required are reported and approved

under OMB Control No. 0910–0032.

However, the draft guidance

recommends that additional information

be provided for certain drugs. This

additional information should be

provided if an assessment of

microbiological safety determines that a

new animal drug produces residues in

foods that are microbiologically active

in the human colon. The likely

respondents to this collection of

information are sponsors of

antimicrobial new animal drugs that

will be used in food-producing animals.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Guidance No. of

Respondents

Annual Frequency

per Response

Total Annual

Responses

Hours per

Response Total Hours

Assessments (including studies) of

safety of antimicrobial drug residues

that are microbiologically active in the

human colon 5 1 5 14,110 70,550

1There are no capital costs or operating and maintenance costs associated with this collection of information.

The estimates in table 1 of this

document resulted from discussions

with sponsors of new animal drugs. The

estimated burden includes studies,

analysis of data, and writing the

assessment. The number of respondents

provided is based on current

experience, however, the number may

change in the future.

III. Comments

This draft guidance document is being

distributed for comment purposes only

and is not intended for implementation

at this time. Interested persons may

submit to the Dockets Management

Branch (address above) written or

electronic comments regarding this draft

guidance document. Submit written or

electronic comments by March 27, 2002

to ensure adequate consideration by the

VICH Microbial Safety Task Force and

in the development of the final

guidance. Two copies of any comments

are to be submitted, except that

individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. A copy of the

draft guidance and received comments

are available for public examination in

the Dockets Management Branch

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

through Friday.

Submit written comments concerning

the information collection requirements

to the Dockets Management Branch by

March 27, 2002. A copy of the

document and received comments are

available for public examination in the

Dockets Management Branch between 9

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

Friday.

IV. Electronic Access

Electronic comments may be

submitted electronically on the Internet

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

ecomments. Once on this Internet site,

select [Insert Docket Number for this

publication] ‘‘Assessment of the Effects

of Antimicrobial Drug Residues from

Food of Animal Origin on the Human

Intestinal Flora’’ and follow the

directions. Copies of the draft guidance

entitled ‘‘Assessment of the Effects of

Antimicrobial Drug Residues from Food

of Animal Origin on the Human

Intestinal Flora’’ may be obtained on the

Internet from the CVM home page at

http://www.fda.gov/cvm.

Dated: December 18, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–31713 Filed 12–26–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Indian Health Service

Proposed Collection; Comment

Request

AGENCY: Indian Health Service, HHS.

ACTION: Request for public comment: 60-

day proposed collection; Hoz’ho’nii: An

intervention to increase breast and

cervical cancer screening among Navajo

women.

SUMMARY: In compliance with section

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

Reduction Act of 1995, to provide a 60-

day advance opportunity for public

comment on proposed information

collection projects, the Indian Health

Service (IHS) is publishing for

comments a summary of a proposed

information collection to be submitted

to the Office of Management and Budget

(OMB) for review.

Federal Register / Vol. 66, No. 248 / Thursday, December 27, 2001 / Notices 66913

Proposed Collection: Title: Hoz’ho’nii:

An Intervention to Increase Breast and

Cervical Cancer Screening Among

Navajo Women. Type of Information

Collection Request: New. Form Number:

None. Need and Use of the Information

Collection: The information is needed to

evaluate a culturally appropriate

education outreach program designed to

increase breast and cervical cancer

screening among Navajo women ages 20

and older. The purpose is to identify

barriers that may prevent Navajo women

from participating in breast and cervical

cancer screening by comparing changes

in knowledge, attitudes, and behaviors

of three study groups; educational

outreach only, education outreach plus

chapter-based clinic, and a control

group. Results will be used to assess the

impact of the impact of the educational

outreach program, improve breast and

cervical cancer screening, and to guide

the IHS and Tribal health programs in

the delivery of culturally appropriate

intervention to reduce mortality rates

from breast and cervical cancer among

Navajo women. Affected Public:

Individuals. Type of Respondents:

Individuals.

The table below provides the

estimated burden response for this

information collection:

ESTIMATED BURDEN RESPONSE TABLE

Data collection instrument

Estimated

number of

respondents

Responses

per respondentAverage burden hour per response* Total annual

burden hrs

KAB Pretest .......................................................... 450 1 0.42 hr (25 minutes) ............................................. 188.0

KAB Post test ....................................................... 450 1 0.42 hr (25 minutes) ............................................. 188.0

Interviews .............................................................. 30 1 0.25 hr (15 minutes) ............................................. 8.0

Total .................................................................. 930 1 ............................................................................... 384.0

* For ease of understanding, burden hours are also provided in actual minutes.

There are no Capital Costs, Operating Costs and/or Maintenance Costs to report for this information collection.

Request for Comments: Your written

comments and/or suggestions are

invited on one or more of the following

points: (1) Whether the information

collection activity is necessary to carry

out an agency function; (b) whether the

agency processes the information

collected in a useful and timely fashion;

(c) the accuracy of public burden

estimate (the estimated amount of time

needed for individual respondents to

provide the requested information); (d)

whether the methodology and

assumptions used to determine the

estimate are logical; (e) ways to enhance

the quality, utility, and clarity of the

information being collected; and (f)

ways to minimize the public burden

through the use of automated,

electronic, mechanical, or other

technological collection techniques or

other forms of information technology.

Send Comments and Requests For

Further Information: Send your written

comments, requests for more

information on the proposed collection,

or requests to obtain a copy of the data

collection instrument(s) and

instructions to: Mr. Lance Hodahkwen,

Sr., M.P.H., IHS Reports Clearance

Officer, 12300 Twinbrook Parkway,

Suite 450, Rockville, MD 20852.1601,

call non-toll free (301) 443–5938, send

via facsimile to (301) 443–1522, or send

your E-mail requests, comments, and

return address to:

Ihodahkw@hqe.ihs.gov.

Comment Due Date: Your comments

regarding this information collection are

best assured of having their full effect if

received within 60-days of the date of

this publication.

Dated: December 14, 2001.

Michael H. Trujillo,

Assistant Surgeon General, Director, Indian

Health Service.

[FR Doc. 01–31712 Filed 12–26–01; 8:45 am]

BILLING CODE 4160–16–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Cancer Institute; Notice of

Meeting

Pursuant to section 10(a) of the

Federal Advisory Committee Act, as

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

is hereby given of a meeting of the

National Cancer Institute Director’s

Consumer Liaison Group.

The meeting will be open to the

public, with attendance limited to space

available. Individuals who plan to

attend and need special assistance, such

as sign language interpretation or other

reasonable accommodations, should

notify the Contact Person listed below

in advance of the meeting.

Name of Committee: National Cancer

Institute Director’s Consumer Liaison Group.

Date: January 22, 2001.

Time: 2 p.m. to 4 p.m.

Agenda: To follow up on the Survivorship

Forums and receive reports from Working

Groups.

Place: National Cancer Institute, 6116

Executive Boulevard, Suite 300C, Room 3068

A, Rockville, MD 20852 (Telephone

Conference Call).

Contact Person: Elaine Lee, Executive

Secretary, Office of Liaison Activities,

National Institutes of Health, National Cancer

Institute, 6116 Executive Boulevard, Suite

300 C, Bethesda, MD 20892, 301/594–3194.

Any interested person may file written

comments with the committee by forwarding

the statement to the Contact Person listed on

this notice. The statement should include the

name, address, telephone number and when

applicable, the business or professional

affiliation of the interested person.

Information is also available on the

Institute’s/Center’s home page:

deainfo.nci.nih.gov/advisory/dclg/delg.htm,

where an agenda and any additional

information for the meeting will be posted

when available.

(Catalogue of Federal Domestic Assistance

Program Nos. 93.392, Cancer Construction;

93.393, Cancer Cause and Prevention

Research; 93.394, Cancer Detection and

Diagnosis Research; 93.395, Cancer

Treatment Research; 93.396, Cancer Biology

Research; 93.397, Cancer Centers Support;

93.398, Cancer Research Manpower; 93.399,

Cancer Control, National Institutes of Health,

HHS)

Dated: December 14, 2001.

LaVerne Y. Stringfield,

Director, Office of Federal Advisory

Committee Policy.

[FR Doc. 01–31704 Filed 12–26–01; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Cancer Institute; Notice of

Closed Meeting

Pursuant to section 10(d) of the

Federal Advisory Committee Act, as

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