Federal Register / Vol. 66, No. 119 / Wednesday, June 20, 2001 / Notices 33095

purchasers for resale have not already

received such notice pursuant to Part VI

E). Part X B requires proposed

respondents to institute a purchaser for

resale order compliance surveillance

program and Part X C states that

proposed respondents must terminate

sales to those purchasers for resale they

know or should know are violating Parts

I through V of the proposed order. Part

XI would allow proposed respondents

to make any representation for any drug

that is permitted by the FDA in the

drug’s labeling, and would allow

proposed respondents to make any

representation that is specifically

permitted in the labeling for any

product by regulations promulgated by

the FDA pursuant to the Nutrition

Labeling and Education Act of 1990.

Part XII of the proposed order

contains record keeping requirements

for materials that substantiate, qualify or

contradict claims covered by the

proposed order. Part XIII of the

proposed order requires distribution of

a copy of the order to current and future

officers, employees, and agents. Part

XIV provides for Commission

notification upon a change in the

proposed corporate respondent and Part

XV requires Commission notification

when the proposed individual

respondent changes his business or

employment. Part XVI requires the

proposed respondents to file with the

Commission a report demonstrating

compliance with the terms and

provisions of the order. Part XVII

provides for the termination of the order

after twenty (20) years under certain

circumstances.

The purpose of this analysis is to

facilitate the public comment on the

proposed order, and it is not intended

to constitute an official interpretation of

the agreement and the proposed order or

to modify in any way their terms.

By direction of the Commission.

Donald S. Clark,

Secretary.

[FR Doc. 01–15546 Filed 6–19–01; 8:45am]

BILLING CODE 6750–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement 01106]

Addressing Asthma From a Public

Health Perspective; Notice of

Availability of Funds

A. Purpose

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 2001

funds for a cooperative agreement

program for ‘‘Addressing Asthma from a

Public Health Perspective.’’ This

program addresses the ‘‘Healthy People

2010’’ focus areas Environmental

Health, Respiratory Diseases and

Occupational Safety and Health.

The purpose of the program is: Part A:

Developing State Capacity to Address

Asthma and Part B: Implementation of

State Asthma Plans.

This funding is not to be used for any

type of research.

B. Eligible Applicants

Assistance will be provided only to

health departments of States or their

bona fide agents, including the District

of Columbia, the Commonwealth of

Puerto Rico, the Virgin Islands, the

Commonwealth of the Northern Mariana

Islands, American Samoa, Guam, the

Federated States of Micronesia, the

Republic of the Marshall Islands, the

Republic of Palau, and federally

recognized Indian tribal governments.

In consultation with States, and with

the written concurrence of the State,

assistance may be provided to political

subdivisions of States.

Part A: Eligible applicants are those

entities listed above that do not have a

finalized comprehensive asthma plan or

a well developed asthma surveillance

system. Grantees currently funded by

CDC Announcement #99109

(Attachment 1) are not eligible to apply.

Part B: Eligible applicants are those

entities listed above that have a

completed comprehensive asthma plan

and have an operational surveillance

system for asthma. Grantees currently

funded by CDC Announcement #99109

are eligible to apply. However, if

awarded funds under Part B of this

announcement, applicant will lose

funds under Announcement #99109.

An eligible applicant may apply for

both Part A and Part B; however, only

one award per applicant will be made.

To apply for both parts of this

announcement, applicants must submit

separate applications for Part A and Part

B.

Note: Title 2 of the United States Code,

Chapter 26, Section 1611 states that an

organization described in section 501(c)(4) of

the Internal Revenue Code of 1986 that

engages in lobbying activities is not eligible

to receive Federal funds constituting an

award, grant, cooperative agreement,

contract, loan, or any other form.

C. Availability of Funds

Approximately $3,600,000 is available

in FY 2001 to fund awards under this

announcement. Funding estimates may

change.

Part A: Developing State Capacity to

Address Asthma. Approximately

$2,000,000 is available to fund

approximately 7–12 awards. It is

expected that the average award will be

$200,000. Additionally, $100,000 is

available to increase Part A awards up

to $10,000 each, if an occupational

component is included in the

application and is favorably reviewed.

Part B: Implementation of State

Asthma Plans. Approximately

$1,500,000 is available to fund

approximately 2–4 awards. It is

expected that the average award will be

$700,000.

It is expected that the awards will

begin on or about September 30, 2001

and will be made for a 12-month budget

period within a project period of up to

3 years for Part A and 5 years for Part

B.

Continuation awards within the

approved project periods will be made

on the basis of satisfactory progress as

evidenced by required reports and the

availability of funds.

Applicant should document

assurance of ability of project staff to

travel to Atlanta to participate in the

CDC National Asthma Conference and/

or grantee meetings and willingness to

share innovations, information, data and

materials.

D. Program Requirements

In conducting activities to achieve the

purpose of this program, the recipient

will be responsible for the activities

under 1. (Recipient Activities), and CDC

will be responsible for the activities

listed under 2. (CDC Activities).

Part A. Developing State Capacity to

Address Asthma

1. Recipient Activities:

a. Develop or finalize a

comprehensive State asthma plan.

b. Develop and organize collaborative

linkages with appropriate agencies and

organizations.

c. Implement a new (or enhance an

existing) asthma surveillance system.

d. Begin the statewide intervention

program upon completion of the plan.

33096 Federal Register / Vol. 66, No. 119 / Wednesday, June 20, 2001 / Notices

e. Evaluate all activities ongoing and

document lessons learned at the end of

the project.

Part B. Implementation of State Asthma

Plans

a. Maintain existing statewide

coalition and partnership activities to

oversee implementation and evaluation

of the plan. Expand partnership

activities as appropriate.

b. Maintain existing asthma-related

activities currently underway in the

health agency and expand as

appropriate.

c. Implement defined aspects of the

completed State/territorial/tribal asthma

plan. Assure institutionalization of

intervention activities.

d. Expand and continue existing

surveillance efforts related to asthma

occurrence, severity, management and

other indicators in order to monitor the

effectiveness of the intervention

activities.

e. Evaluate each intervention activity

and the program as a whole; document

lessons learned.

2. CDC Activities for Parts A and B

a. Collaborate with the recipient in all

stages of the project and coordinate joint

activities among all grantees.

b. Provide programmatic technical

assistance, as requested.

c . Convene meetings for grantees to

share experiences, data, and materials.

E. Content

Letter of Intent (LOI)

A one-page, non-binding LOI is

requested, and it should include:

1. Name and address of organization

2. Contact person

3. Which part of the announcement,

Part A, Part B or both, applied for.

The LOI will be used to ascertain the

level of interest in this announcement

and to assist in determining the size and

composition of the independent review

panel.

Applications

Your application will be evaluated on

the criteria listed, so it is important to

follow them in laying out your program

plan. The narrative should be no more

than 30 pages for Part A, or 40 pages for

Part B, double-spaced, printed on one

side, with one inch margins, and

unreduced font. The application must

be submitted unstapled and unbound.

Part A: Developing State Capacity to

Address Asthma. Include each of the

following sections:

1. Description of Problem

Describe what is known of the asthma

problem in the State or jurisdiction and

efforts, to date, to begin to

systematically address the problem.

Describe the barriers that need to be

addressed in the development of a

comprehensive asthma program in the

State. Describe how the agency as a

whole will focus its efforts on asthma.

If the applicant seeks funds for the

occupational asthma component,

describe the plan and justify its need.

2. Collaborative Relationships

Describe experiences with

collaborative relationships around

asthma or with other chronic or

environmentally related or work-related

disease problems requiring extensive

collaborative relationships both within

and outside the agency.

Specifically define the approach to be

used to establish or further develop

these relationships. Documentation of

partnerships with the clinical

community is essential, including the

applicant’s plan for working with local

health agencies, physician organizations

and community health centers. In

addition, applicants should document

their plan to work with their State

chapter of the American Lung

Association, local education authorities,

and groups or organizations that serve

minority or other populations

experiencing a disproportionate burden

of asthma. If one or more of these

partners will not be included, the

applicant should explain why.

Letters of commitment from specific

organizations, including a statement of

their intention to collaborate, will

considerably strengthen the application.

Note that grant funds should be used to

leverage asthma program development

in the State/territory/tribe along with

resources from other collaborative

agencies and organizations.

3. Planning and Evaluating Processes

For those States/territories/tribes

without an existing asthma plan,

describe the process by which the plan

will be developed. Include information

about the agencies and organizations

that will be included in the planning

process. Include a description about

how the collaborative relationship will

be used when the agency has a plan in

place and is ready to implement

interventions. The plan must address all

persons with asthma in the State

regardless of age, race/ethnicity or

gender. Include a discussion of the

place of occupational and work-related

asthma in the plan if funds are

requested for that component.

If a State asthma plan already exists,

describe the portion of the plan to be

implemented with these grant funds.

Provide specific objectives for the

proposed activities that are realistic,

time-phased, and measurable and reflect

the three-year period of this

announcement. Describe how progress

made toward meeting objectives will be

evaluated and documented.

4. Surveillance System

The applicant should include a

surveillance system plan containing: (a)

A description of data currently available

to the program; (b) the data the agency

will obtain; (c) plans for identifying atrisk populations (e.g., ethnic groups,

socio-economic groups, and/or

geographic areas); (d) how the agency

will use this data to develop ongoing

surveillance; and (e) how the

surveillance data will be used to

support policy development, program

planning and evaluation activities.

Participants funded under this

announcement will be expected to use

the Behavioral Risk Factor Surveillance

System (BRFSS) supplemental asthma

module at the first available

opportunity, preferably within the first

year of the project.

5. Management and Staffing Plan

Describe the qualifications and roles

of the trained public health

professionals to serve as: an asthma

coordinator for the agency’s program

and to manage the planning process and

conduct other programmatic activities;

an epidemiologist, at least 0.5 FTE, to

develop and implement surveillance

activities for the asthma project; and a

supervisor who will assure support for

the project staff. Other support positions

may also be proposed.

Include a plan to expedite filling of

the staff position(s) and assure that they

have been or will be approved by the

applicant’s personnel system. Where

current staff already fill these roles and

federal resources are not to be used for

their support, information on the

position and qualification of the person

filling the position should be provided.

Describe the organizational location of

the proposed staff, their relation to the

State’s ‘‘asthma contact’’ (the position in

the agency currently responsible for

contact with CDC on asthma issues),

and the support within the

organizational structure for the activities

defined for the project staff. Include an

organizational chart for the unit in

which the activity will be located and,

at a minimum, the next two levels above

it.

For each position describe the

primary roles and responsibilities for

the project staff over the three-year grant

period. Also, include the specific staff

Federal Register / Vol. 66, No. 119 / Wednesday, June 20, 2001 / Notices 33097

activities that will contribute to meeting

each objective.

6. Budget

This section must include a detailed

first-year budget and narrative

justification and future annual

projections. The applicant should

describe the program purpose for each

budget item. For contracts contained

within the application budget,

applicants should name the contractor,

if known; describe the services to be

performed; justify the use of a third

party; and provide a breakdown or a

justification for the estimated costs of

the contracts, the kinds of organizations

or parties to be selected, the period of

performance, and the method of

selection. The budget should include

travel for project staff to meet once per

year with CDC and other grantees. Any

requested funds for an occupational

component must be presented

separately, with the same level of detail,

immediately following the main budget

narrative justification.

Part B: Implementation of State Asthma

Plans

Include each of the following

sections:

1. Description of Problem

Describe what is known of the asthma

problem in the State or jurisdiction.

Include a description of populations at

increased risk of poorly controlled

asthma within the jurisdiction (e.g.,

ethnic groups, socio-economic groups,

geographic areas). Attach published

surveillance reports that describe

asthma within the jurisdiction including

a report on asthma in the Medicaid

population.

2. Asthma Plan

Provide the existing asthma plan as an

attachment. Describe how the asthma

plan and the plan’s implementation

strategy were developed, including a list

of the partners participating in the

process (if not part of the published

plan) and support for the final plan as

demonstrated by a letter from the

Agency’s Health or Medical Director

and from key partners (e.g., the Director

of the State/territorial American Lung

Association and key professional

societies). Attach a copy of the final

plan. The final plan (or attachments to

that plan) must include: (a) an

assessment of the asthma burden in the

State/tribe/territory using populationbased data; (b) measurable objectives

that address people with asthma across

the State/territory/tribe and include

people with asthma of all ages, race/

ethnic groups, and gender; (c) a

description of how the plan’s

implementation would reach all persons

with asthma in the State regardless of

age, race/ethnicity, or gender, (d)

proposed strategies to meet the plan’s

objectives, including, but not limited to,

efforts to (d.1) expand surveillance for

asthma, (d.2) improve provider

compliance with the National Asthma

Education and Prevention Program’s

‘‘Guidelines on the Diagnosis and

Management of Asthma,’’ (Guidelines

for the Diagnosis and Management of

Asthma. National Institutes of Health,

National Heart, Lung, and Blood

Institute. NIH Publication No. 97–4051,

April 1997), (d.3) improve the skills of

patients and families affected by asthma

to manage the disease, and (d.4)

evaluate the program’s implementation

and measure progress toward objectives;

and (e) an assessment of existing and

needed resources to implement these

strategies.

3. Partnership Oversight

Describe how the partners who

developed the asthma plan will

continue to implement and monitor the

intervention activity and modify the

plan over time.

4. Surveillance and Evaluation

Describe the surveillance system

currently in place within the health

agency and its ability to support the

evaluation of intervention activities and

a continued planning process. All

asthma indicators assessed over time

should be noted (including, but not

limited to, prevalence, mortality,

hospitalization, emergency care and

measures of disease management

status), and a copy of all asthma

surveillance reports, brochures, or

publications should be provided. If

available, analyses of Medicaid data on

persons with asthma should be

provided. Ability to provide

measurement of progress in meeting all

plan objectives should be addressed.

Intentions to use BRFSS asthma

module(s) and the frequency of use

should be included; also, plans for

further development of the asthma

surveillance activity should be

presented in detail. Surveillance of

occupational asthma is encouraged and

must be discussed.

5. Implementation of the Asthma Plan

a. Identify the specific objectives of

the asthma plan that are to be focused

upon and the specific intervention

strategies from the plan to be

implemented that will use the resources

provided through this announcement.

Interventions that change systems and

individuals to provide improved disease

management or education are preferred.

Provide specific realistic, measurable,

and time-phased process objectives for

each of the strategies and interventions

to be implemented that reflect the five

year period of this announcement.

Describe how both process and outcome

objectives for all activities will be

evaluated and documented.

b. Demonstrate the scientific basis for

proposed interventions. If proposed

interventions include case management

programs, assure that patients enrolled

are those with moderate to severe

persistent asthma and are receiving care

consistent with the National Asthma

Education and Prevention Program

(NAEPP) Clinical Practice Guidelines

(Guidelines for the Diagnosis and

Management of Asthma. National

Institutes of Health, National Heart,

Lung, and Blood Institute. NIH

Publication No. 97–4051, April 1997).

Explain how it was decided by members

of the statewide partnership group that

these particular objectives and strategies

will be addressed.

c. Describe what objectives and

strategies from the plan are currently

being addressed utilizing other

resources.

d. Demonstrate that the plan

addresses asthma in persons of all ages,

race/ethnic groups, and gender and

includes key environments in which

persons with asthma spend significant

time (e.g., home, school, workplace).

Include a discussion on the place of

occupational asthma in the plan.

e. Explain how the resources from this

solicitation will be utilized to leverage

additional resources for implementation

of other components of the plan.

Explain how interventions will be

institutionalized and sustained without

these funds.

6. Management and Staffing for

Intervention Activities

a. Describe existing asthma program

staff within the health department and

their management structure, the current

function of the asthma staff, and their

role in this project plan. If plan

implementation will be coordinated

from an office other than within the

health department, describe that office

and its staff, the oversight of that office

and its staff, and the ties of that office

to the health agency. Provide an

organizational chart for the health

agency that identifies the unit(s) in and

out of the health agency that will

participate in the proposed activities.

b. Describe asthma surveillance staff

and their role within the project

activities. Describe all staff who will be

responsible for oversight of program

evaluation.

33098 Federal Register / Vol. 66, No. 119 / Wednesday, June 20, 2001 / Notices

c. If intervention activities will be

implemented through contracts, define

the process by which these contracts

will be awarded and monitored.

d. Describe staff available or to be

hired for those aspects of the plan to be

implemented with these resources. For

each position, describe the primary

roles and responsibilities over the fiveyear grant period.

e. Include the specific staff activities

that will contribute to meeting each

objective that is to be addressed. Discuss

the role of the statewide partnership

group in oversight of intervention

activities

f. Document assurance of ability of

key project staff to travel to Atlanta to

participate in the CDC National Asthma

Conference and/or grantee meetings and

willingness to share innovations,

information, data and materials.

7. Budget

This section must include a detailed

first-year budget and narrative

justification and future annual

projections. The applicant should

describe the program purpose for each

budget item. For contracts contained

within the application budget,

applicants should name the contractor,

if known; describe the services to be

performed; justify the use of a third

party; and provide a breakdown or a

justification for the estimated costs of

the contracts, the kinds of organizations

or parties to be selected, the period of

performance, and the method of

selection. The budget should include

travel for key project staff to meet once

per year with CDC and other grantees.

This section should also include a

listing of other funds, outside the

cooperative agreement, that will be used

to support this intervention.

F. Submission and Deadline

Letter of Intent (LOI)

On or before July 19, 2001, submit the

LOI to the Grants Management

Specialist identified in the ‘‘Where to

Obtain Additional Information’’ section

of this announcement.

Submit the original and two copies of

PHS 5161–1 (OMB Number 0920–0428).

Forms are available in the application

kit at the following Internet address:

www.cdc.gov/od/pgo/forminfo.htm.

On or before August 17, 2001, submit

the application to the Grants

Management Specialist identified in the

‘‘Where to Obtain Additional

Information’’ section of this

announcement.

Deadline: Applications shall be

considered as meeting the deadline if

they are either:

1. Received on or before the deadline

date; or

2. Sent on or before the deadline date

and received in time for submission to

the independent review group.

(Applicants must request a legibly dated

U.S. Postal Service postmark or obtain

a legibly dated receipt from a

commercial carrier or U.S. Postal

Service. Private metered postmarks shall

not be acceptable as proof of timely

mailing.)

Late: Applications which do not meet

the criteria in 1. or 2. above will be

returned to the applicant.

G. Evaluation Criteria

Each application will be evaluated

individually against the following

criteria by an independent review group

appointed by CDC.

Part A: Developing State Capacity to

Address Asthma

1. Description of the problem (10 points)

The extent to which the agency’s

commitment to addressing asthma is

demonstrated by accomplishments to

date in understanding the problem.

2. Collaborative Relationships (20

points)

The demonstration and description of

prior successful collaborations to

address asthma or other chronic or

environmentally related or

occupationally-related problems. The

appropriateness of organizations and

agencies identified. The level of

commitment of key organizations as

demonstrated by the content of the

letters of commitment.

3. Planning and Evaluating Processes

(35 points)

For those applicants without an

existing asthma plan, the

appropriateness of the planning and

implementation process proposed. The

extent to which objectives are consistent

with the stated purpose of the

announcement are measurable, timephased and the ability of the applicant

to meet the objectives according to the

specified time table. The adequacy of

the applicant’s plan to monitor progress

toward meeting the stated objectives.

4. Surveillance System Plan (15 points)

The extent to which the description of

the surveillance system includes all

elements outlined in the application

content section and the quality and

extent of submitted surveillance reports.

5. Management and Staffing Plan (20

points)

The extent to which the role of

proposed staff is defined and the agency

has identified adequate qualifications of

and level of commitment for the

proposed staff; and the level of

organizational support available to the

project staff.

6. Budget (not scored)

The extent to which the budget is

reasonable, adequately justified and

consistent with the intended use of the

cooperative agreement funds.

Part B: Implementation of State Asthma

Plans

1. Description of the Problem (5 points)

The extent to which the agency’s

commitment to addressing asthma is

demonstrated by accomplishments to

date in understanding the problem. The

extent to which the agency has been

able to identify populations at increased

risk and effectively disseminate and use

that information in the planning

process.

2. Asthma Plan (20 points)

The extent to which a wide variety of

appropriate partners were engaged to

develop the plan; the commitment by

the Agency to the implementation of

this plan as demonstrated by the

inclusion of a letter of support from the

Secretary of Health or the Agency’s

Medical Director; the extent to which

the intervention plan is supported in the

community by the inclusion of letters of

support from key members of the

community; the extent to which the

asthma plan is comprehensive and

includes the items listed in the

application section for this

announcement.

3. Partnership Oversight (10 points)

The extent to which appropriate

partners will be a part of the

implementation and oversight of the

implementation.

4. Surveillance and Evaluation (20

points)

The current state of the surveillance

system; the quality of surveillance

reports provided; the ability to provide

measurement of progress in meeting all

plan objectives; the plan for appropriate

continued development of the asthma

surveillance activity. The ability to

support evaluation of implementation

activities.

5. Implementation of the Asthma Plan

(30 points)

Clear link between the plan and the

proposed implementation; the

appropriateness and scientific support

for the proposed implementation; the

involvement of statewide partners in

development of the proposed

Federal Register / Vol. 66, No. 119 / Wednesday, June 20, 2001 / Notices 33099

implementation and its monitoring over

time; the use of these resources to

leverage additional resources for plan

implementation; the plans to

institutionalize specific interventions;

specific objectives that are realistic,

measurable and time phased; clear

definition of both process and outcome

measures for the evaluation of

implementation activities.

6. Management and Staffing for

Intervention Activities (15 points)

The current functioning of asthma

staff (program and surveillance) within

the health agency; the description of

staff to be hired or contracts to be

developed; the link of staff to program

objectives; the continued role of the

statewide partnership group. Assurance

that key personnel will attend

scheduled grantee meetings and CDCsponsored national asthma conferences,

and that the applicant agrees to share

innovations, information, data and

materials.

7. Budget (Not scored)

The extent to which the budget is

reasonable, adequately justified and

consistent with the intended use of the

cooperative agreement funds.

H. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two

copies of

1. Annual progress reports;

2. financial status report, no more

than 90 days after the end of the budget

period; and

3. final financial and performance

reports, no more than 90 days after the

end of the project period.

Send all reports to the Grants

Management Specialist identified in the

‘‘Where to Obtain Additional

Information’’ section of this

announcement.

The following additional

requirements are applicable to this

program. For a complete description of

each, see Attachment 2 of the

announcement in the application kit.

AR–7 Executive Order 12372 Review

AR–10 Smoke-Free Workplace

Requirements

AR–11 Healthy People 2010

AR–12 Lobbying Restrictions

I. Authority and Catalog of Federal

Domestic Assistance Number

This program is authorized under

sections 301 and 317 of the Public

Health Service Act, [42 U.S.C. section

241 and 247b], as amended. The Catalog

of Federal Domestic Assistance number

is 93.283.

J. Where to Obtain Additional

Information

This and other CDC announcements

can be found on the CDC home page

Internet address http://www.cdc.gov

Click on ‘‘Funding’’ then ‘‘Grants and

Cooperative Agreements.’’

To obtain business management

technical assistance, contact: Sonia

Rowell, Grants Management Specialist,

Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention,

2920 Brandywine Road, Room 3000,

Atlanta, GA 30341–4146, Telephone

number: (770) 488–2724, Email address:

svp1@cdc.gov.

For program technical assistance,

contact: Leslie P. Boss, Air Pollution

and Respiratory Health Branch, National

Center for Environmental Health,

Centers for Disease Control and

Prevention, Mailstop E–17, 1600 Clifton

Rd., NE, Atlanta, GA 30333, Telephone

number: (404) 498–1002, Email address:

LBoss@cdc.gov.

Dated: June 14, 2001.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 01–15476 Filed 6–19–01; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0051]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request; Adverse

Event Pilot Program for Medical

Devices and Blood Products

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the proposed collection of

information listed below has been

submitted to the Office of Management

and Budget (OMB) for review and

clearance under the Paperwork

Reduction Act of 1995.

DATES: Submit written or electronic

comments on the collection of

information by July 20, 2001.

ADDRESSES: Submit electronic

comments on the collection of

information via the Internet at http://

www.accessdata.fda.gov/scripts/oc/

dockets/edockethome.cfm. Submit

written comments on the collection of

information to the Office of Information

and Regulatory Affairs, OMB, New

Executive Office Bldg., 725 17th St.

NW., rm. 10235, Washington, DC 20503,

Attn: Wendy Taylor, Desk Officer for

FDA.

FOR FURTHER INFORMATION CONTACT:

Peggy Schlosburg, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1223.

SUPPLEMENTARY INFORMATION: In

compliance with 44 U.S.C. 3507, FDA

has submitted the following proposed

collection of information to OMB for

review and clearance.

Adverse Event Pilot Program for

Medical Devices and Blood Products

Under section 519 of the Federal

Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 360i), FDA is authorized to

require manufacturers to report medical

device related deaths, serious injuries,

and malfunctions and to require user

facilities to report device-related deaths

directly to FDA and to manufacturers,

and to report serious injuries to the

manufacturer. Section 213 of the FDA

Modernization Act of 1997 (FDAMA)

amended section 519(b) of the act

relating to mandatory reporting by user

facilities of deaths and serious injuries

and serious illnesses associated with the

use of medical devices. This

amendment required FDA to, by

regulation, replace universal userfacility reporting with a system that is

limited to a ‘‘ * * * subset of user

facilities that constitutes a

representative profile of user reports’’

for device-related deaths and serious

injuries. This amendment is reflected in

section 519(b)(5)(A) of the act.

FDA is the Federal agency charged

with the responsibility for ensuring that

marketed medical products are safe and

effective. To carry out its

responsibilities, the agency needs to be

informed whenever an adverse event or

product problem occurs. Only if FDA is

provided with such information will it

be able to evaluate the risk, if any,

associated with the product and take

whatever action is necessary to reduce

or eliminate the public’s exposure to

this risk. Data collected from user

facilities about problems with medical

devices assist FDA to carry out that

mission as it pertains to medical

devices. Prior to implementing the

regulation to change from universal

user-facility reporting to reporting by a

subset of user facilities, FDA is planning

to conduct a pilot program to evaluate

various aspects of the new program. The

new user-facility program that will be