Federal Register / Vol. 66, No. 6 / Tuesday, January 9, 2001 / Notices 1683

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 the prevention of

treatment.

CDC proposes to separate the two

HIV/AIDS case reports from the current

clearance in order to have the case

reports sent to the appropriate CDC

organizational entity. Under the current

clearance these forms are managed by

the staff within the National Centers for

Infectious Diseases (NCID). Separating

the packages into two clearances will be

more efficient for CDC. These forms are

used to report all HIV/AIDS cases for

children and adults in all 50 states,

Guam, the Pacific Islands, Puerto Rico,

and the Virgin Islands. The information

collected and the methodology used

will remain the same. The data will

continue to be used for the purposes

described in the previous paragraph.

The total annualized burden is 4,373

hours. The total cost to respondents is

estimated at $65,595.

Respondents Number of

respondents

Number of

responses per

respondent

Average

burden per

respondent

(in hrs.)

HIV/AIDS Adult Case Report ....................................................................................................... 55 473 10/60

HIV/AIDS Pediatric Case Report ................................................................................................. 55 4 10/60

Dated: January 2, 2001.

Nancy Cheal,

Acting Associate Director for Policy,

Planning, and Evaluation, Centers for Disease

Control and Prevention (CDC).

[FR Doc. 01–474 Filed 1–8–01; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[30DAY–14–01]

Agency Forms Undergoing Paperwork

Reduction Act Review

The Centers for Disease Control and

Prevention (CDC) publishes a list of

information collection requests under

review by the Office of Management and

Budget (OMB) in compliance with the

Paperwork Reduction Act (44 U.S.C.

Chapter 35). To request a copy of these

requests, call the CDC Reports Clearance

Officer at (404) 639–7090. Send written

comments to CDC, Desk Officer, Human

Resources and Housing Branch, New

Executive Office Building, Room 10235,

Washington, DC 20503. Written

comments should be received within 30

days of this notice.

Proposed Project

Geo-Analysis of HIV Prevention

Services Provided by CDC to Directly

and Indirectly Funded CommunityBased Organizations (CBOs). NEW—The

Centers for Disease Control and

Prevention (CDC), National Center for

HIV, STD, and TB Prevention

(NCHSTP), Division of HIV/AIDS

Prevention (DHAP) proposes an

evaluation project which will build on

the knowledge gained from the previous

studies to provide a multi-level, georeferenced review of CDC-funded,

community-based organization (CBO)-

provided HIV prevention services. The

purposes of this project are: (1) To

contribute to the construction of a

national database of HIV prevention

activities by developing a geo-coded

database that identifies, locates and

maps all CBOs directly and indirectly

funded by CDC in the US and its

territories, and (2) to evaluate the

comprehensiveness of HIV prevention

services in geographic areas across the

United States of America and territories

through the use of Geographic

Information Systems (GIS) technology as

the primary analytical tool.

This project is being tasked under the

Enhanced Program Assessments with

Laboratory Capability Task Order

Contract (200–96–0511) because of its

program evaluation component. By

using GIS to identify gaps in service

provision within a given geographic

area, program changes can be

recommended to those health

departments and CBOs participating in

the project. These recommended

changes may include adjusting services

provided or target populations in an

effort to close identified gaps.

Collaboration between government

agencies and CBOs with access to a

particular group at risk has been a

traditional approach in public health in

the United States. CDC promotes the

collaboration and coordination of HIV

prevention efforts between CBOs and of

CBOs with State health departments,

affiliates of National and Regional

Minority Organizations(NRMOs), HIV

prevention service agencies, and other

public agencies including substance

abuse programs, educational institutions

and the criminal justice system. CDC

promotes collaboration as a strategy for

(1) improving access to and for at risk

populations and communities, (2)

improving the direct delivery of

services, (3) improving referral of clients

to services, and (4) creating

comprehensive HIV services in

designated geographical jurisdictions.

The use of GIS will enhance the

accomplishment of these three goals by

providing information to funders and

other shareholders to enhance CBOs in

their efforts to provide interventions

and client referrals and services that are

accessible to the populations in need of

them. This data will assist the CDC to

determine the effectiveness of federal

funding, whether the funding is

affecting the designated high risk or

infected groups such as

disproportionately affected minorities

where they live, or whether or not there

are available programs to link with for

more comprehensive services.

The project will use appropriate

technology to minimize respondent

burden. A self-report mailed

questionnaire, three pages in length,

will be mailed. Attached, will be two

maps of the geographical area (city and

surrounding metropolitan area) where

each CBO is located. The use of maps

eliminates the need to locate maps to

respond to questions concerning

location and distance. This project will

not be requesting information of a

sensitive nature. The project deals with

the types of interventions offered to

high risk or HIV positive individuals,

location and access.

The CDC anticipates one person per

CBO (total # of approximately 2000) to

complete the data collection form once

during the 2000 for approximately 30

minutes. Therefore, the total response

burden is estimated at 1000 hours.

1684 Federal Register / Vol. 66, No. 6 / Tuesday, January 9, 2001 / Notices

Respondents Number of

respondents

Number of

responses

Average hour

burden per

response

Directly Funded CBOs ................................................................................................................. 184 1 30/60

Indirectly Funded CBOs .............................................................................................................. 1816 1 30/60

Dated: January 2, 2001.

Nancy E. Cheal,

Acting Associate Director for Policy, Planning

and Evaluation, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 01–475 Filed 1–8–01; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1669]

Electronic Filing of Drug Registration

and Listing Information: Notice of Pilot

Project

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is seeking

volunteers to participate in a pilot

project involving the electronic filing of

drug registration and listing

information, as described in FDA’s

regulations. Manufacturers, repackers,

and relabelers who engage in the

manufacture, preparation, propagation,

or processing of human or veterinary

drugs and human biological products

are required under current regulations

to submit a listing of every product in

commercial distribution. This

information is currently submitted in

paper format. FDA is developing an

electronic system for submitting the

required information, and is seeking

volunteers to test the pilot system.

DATES: Submit written requests to

participate in the pilot project by

February 8, 2001. Comments on this

pilot project can be submitted at any

time.

ADDRESSES: Submit written requests to

participate and comments regarding this

pilot project to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

James R. Hunter, Food and Drug

Administration, Center for Drug

Evaluation and Research (HFD–9), 5600

Fishers Lane, Rockville, MD 20857,

301–594–6779, e-mail:

hunterj@cder.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

Under current FDA’s regulations (part

207 (21 CFR part 207)), manufacturers,

repackers, and relabelers who engage in

the manufacture, preparation,

propagation, compounding, or

processing of human or veterinary drugs

and human biological products must

register annually with FDA by

submitting Form FDA 2656 (Registration

of Drug Establishment). In addition,

registrants must update their product

listing information by using Form FDA

2657 and/or Form FDA 2658 every June

and December, or at the discretion of the

establishment, when any change occurs.

This entire process is currently done

manually (i.e., with a paper process).

This process is very labor intensive and

time consuming. FDA is trying to

streamline the process by developing an

electronic system in which registrants

could automatically register and list, as

well as provide updates.

The purpose of the pilot project is

twofold. First, the pilot project will test

FDA’s systems for receiving electronic

filings under part 207. Second, the pilot

project will provide volunteers with

experience in using the prototype

system that will enable them to provide

technical feedback to FDA about the

system.

II. Pilot Project Description

The pilot project is part of FDA’s

efforts to implement electronic filing.

Eventually, FDA staff expects to

recommend that FDA require electronic

filings under part 207. Participants in

this pilot project will have the

opportunity not only to assist FDA in

making its determination on electronic

filing, but also to familiarize themselves

with the process at an early stage of

development.

A. Initial Approach

Initially, a limited group of voluntary

participants will take part in testing the

electronic filing prototype. This group

will be incrementally expanded during

the pilot project to ensure that as many

volunteers as possible get the

opportunity to participate and that all

functional components of the system are

adequately tested. The initial group of

participants will include manufacturers,

repackers, relabelers, and private label

distributors of human prescription and

over the counter drug and biological

products and manufacturers of

veterinary drug products that currently

have more than 25 products listed with

the agency. During the pilot project,

information submitted will be made

available to the public by the agency via

the Internet at http://www.fda.gov/cder.

Participants in the pilot project will be

asked to test specific aspects of the

electronic filing system and to provide

technical feedback.

B. Scope

Existing registration and listing

requirements will not be waived,

suspended, or modified for purposes of

this pilot project. Thus, participants

must continue to submit paper

documents in accordance with FDA’s

existing filing requirements (part 207).

The paper copy will serve as the official

copy under existing regulations during

the pilot project.

The pilot project will test a prototype

for electronic filing over the Internet of

information to fulfill the requirements

of section 510 of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 360).

Written requests to participate in the

pilot project should be submitted to the

Dockets Management Branch (address

above) and identified with the docket

number found in brackets in the

heading of this document. Include the

participants name, company name,

company address, and telephone

number. In addition, include in your

written request to participate the

number of products you currently have

listed with the agency, the number of

establishments you currently have

registered with the agency, the type of

products you process (i.e., human,

biologic, or veterinary), the process(es)

you perform (i.e., manufacture,

repackage, relabel, distribute), and the

kind of products you process (i.e.,

prescription, over the counter, active

pharmaceutical ingredients (bulk), or,

homeopathic).

Interested persons may submit to the

Dockets Management Branch (address

above) written comments regarding this

pilot project. Two copies of any

comment 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. FDA will