9580 Federal Register / Vol. 66, No. 27 / Thursday, February 8, 2001 / Notices

other bloodborne pathogen infections;

and (6) develops, implements, and

evaluates the effectiveness and impact

of interventions to prevent the

dissemination of infections endemic in

the community (e.g., as tuberculosis and

influenza) in healthcare settings.

Health Communications Section

(CRM33). (1) With input from DHQP

branches, NCID/CDC Centers, Institutes

and Offices (CIO’s), partners and

stakeholders, develops, implements,

and evaluates the effectiveness of the

DHQP health communications strategic

plan to (a) deliver effective messages to

target audiences that protect patients,

protect healthcare personnel, and

promote quality healthcare and (b)

inform patients, partners, the public,

decision makers, and other constituents

about these issues; (2) coordinates

provision of DHQP technical support

and consultation to partners and

constituents on the prevention of

healthcare-associated infections/

antimicrobial resistance, related adverse

events, and medical errors; (3) develops

and tests health communication

materials in a variety of media,

including but not limited to electronic

and print; (4) develops and implements

a real-time communication network for

the delivery of information to

intramural and extramural partners and

stakeholders; (5) disseminates

information to medical, technical,

scientific, and lay audiences and news

media about healthcare-associated

infections/antimicrobial resistance,

adverse events, and medical errors; (6)

develops, coordinates, and maintains

DHQP website; (7) develops and tests

material, technologies, and strategies for

training programs to prevent and control

healthcare-associated infections/

antimicrobial resistance, related adverse

events, and medical errors; (8) develops

and implements national health

communication campaigns to promote

the prevention and control of

healthcare-associated infections/

antimicrobial resistance, related adverse

events, and medical errors; (9) evaluates

the effectiveness of DHQP’s health

communication strategies to determine

the impact and contribution to

prevention and control of healthcareassociated infections/antimicrobial

resistance, related adverse events, and

medical; and (10) oversees DHQP’s

scientific and editorial clearance

process for all print and non-print

materials and ensures adherence to and

consistency with CDC’s scientific and

editorial policies and clearance

processes.

Healthcare Outcomes Branch (CRM4).

(1) Evaluates the impact of healthcareassociated infections/antimicrobial

resistance, related adverse events, and

medical errors on healthcare outcomes

and costs in order to establish priorities

for DHQP intervention programs; (2)

improves methods to measure

healthcare outcomes, performance, and

cost-effectiveness of intervention

strategies; (3) improves systems by

which health organizations collect,

manage, analyze, report, and respond to

data on healthcare outcomes,

healthcare-associated adverse events,

and medical errors; (4) implements and

coordinates the National Healthcare

Safety Network (NHSN) (a

representative sample of healthcare

organizations that report data on

targeted healthcare-associated adverse

events and medical errors) to obtain

locally relevant and scientifically valid

benchmarks and performance

measurements that promote healthcare

quality and value; (5) provides national

estimates of targeted adverse events and

medical errors among selected

populations of patients across the

spectrum of healthcare delivery sites;

and (6) provides national estimates of

targeted occupational illnesses and

injuries among healthcare workers

across the spectrum of healthcare

delivery sites.

Quality Research Section (CRM42). (1)

Evaluates the impact of healthcareassociated infections/antimicrobial

resistance, related adverse events, and

medical errors on patient outcomes,

healthcare costs, and resource

utilization; (2) develops scientifically

valid and locally relevant methods of

risk adjustment for interpreting and

comparing performance measures and

healthcare outcomes and costs among

targeted populations; (3) develops

analytic methods to provide reliable

national estimates of the frequency and

impact of targeted adverse health events

among patients and healthcare

personnel; and (4) develops analytic

methods to evaluate the relationship

among healthcare structure, processes of

care, and healthcare outcomes.

Performance Measurement Section

(CRM43). (1) with collaborating

partners, establishes, maintains, and

expands the NHSN to collect, report,

monitor, interpret, and disseminate data

relevant to healthcare safety, quality,

and value; (2) with collaborating

partners, develops and validates

standard definitions of monitored

healthcare events in targeted

populations and healthcare settings.

These events may include medical

device-associated infections/adverse

events/errors, drug-associated adverse

events/errors, antimicrobial use/misuse,

blood product-associated infections/

adverse events/errors, procedureassociated infections/adverse events/

errors, laboratory-associated adverse

events/errors, vaccine-preventable and

antimicrobial-resistant infections, and

occupational exposures and infections;

(3) develops, implements, and validates

protocols for reporting monitored health

events in targeted populations and

healthcare settings; (4) develops analytic

tools to create performance measures

and other locally relevant data to

enhance quality promotion activities; (5)

collaborates with NCID, other CDC

CIOs, and other information system

partners to ensure that the NHSN and

related information systems adhere to

relevant standards and emerging

architecture for integrated surveillance

and information management; (6)

coorindates translation of NHSN

functional specifications and CDC

standards to software developers and

maintains ongoing communication with

developers as the system evolves; (7)

coordinates NHSN data management,

data warehousing, and analysis systems;

(8) develops information system

capacity and transfer protocols to

acquire data from various existing

databases and sources to provide

national estimates of monitored adverse

health events among patients and

healthcare personnel; (9) develops,

updates, and disseminates public use

de-identified data sets relevant to

healthcare outcomes, infections and

other adverse events, and medical

errors; (10) investigates novel strategies

for data acquisition and electronic

reporting of adverse event and relevant

data from healthcare organization

information systems; and (11) identifies

novel strategies for electronic detection,

automated reporting, and interpretation

of healthcare-associated infections/

antimicrobial resistance, related adverse

health events, and medical errors.

Dated: January 30, 2001.

Jeffrey P. Koplan,

Director.

[FR Doc. 01–3221 Filed 2–7–01; 8:45 am]

BILLING CODE 4160–18–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0051]

Agency Information Collection

Activities; Proposed Collection;

Comment Request; Adverse Event

Pilot Program for Medical Devices and

Blood Products

AGENCY: Food and Drug Administration,

HHS.

Federal Register / Vol. 66, No. 27 / Thursday, February 8, 2001 / Notices 9581

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 (the

PRA), Federal agencies are required to

publish notice in the Federal Register

concerning each proposed collection of

information, and to allow 60 days for

public comment in response to the

notice. This notice solicits comments

concerning a pilot project FDA plans to

conduct to obtain adverse event reports

from user facilities.

DATES: Submit written or electronic

comments on the collection of

information by April 9, 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 Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. All

comments should be identified with the

docket number found in brackets in the

heading of this document.

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: Under the

PRA (44 U.S.C. 3501–3520), Federal

agencies must obtain approval from the

Office of Management and Budget

(OMB) for each collection of

information they conduct or sponsor.

‘‘Collection of information’’ is defined

in 44 U.S.C. 3502(3) and 5 CFR

1320.3(c) and includes agency requests

or requirements that members of the

public submit reports, keep records, or

provide information to a third party.

Section 3506(c)(2)(A) of the PRA (44

U.S.C. 3506(c)(2)(A)) requires Federal

agencies to provide a 60-day notice in

the Federal Register concerning each

proposed collection of information

before submitting the collection to OMB

for approval. To comply with this

requirement, FDA is publishing notice

of the proposed collection of

information set forth in this document.

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.

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 user

facility 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

comprised of a subset of user facilities

is called the Medical Product

Surveillance Network (MedSuN). Two

FDA Centers, the Center for Devices and

Radiological Health (CDRH) and the

Center for Biologics Evaluation and

Research (CBER) are participating in

this project. Data collected from the

pilot will aid FDA in fulfilling its

mission to monitor the safety and

effectiveness of marketed medical

devices as they are used in clinical

settings and to determine what aspects

of the pilot program should be

implemented in the national program.

The current FDA universal user-facility

reporting system remains in place

during the piloting of the new program,

and will remain until FDA implements

the new MedSuN national system by

regulation.

An electronic format of the medical

device related sections of the mandatory

MedWATCH form (form 3500A; OMB

Control number 0910–0291) will be

accessible to the participating medical

device user facilities and the

participating blood establishments. The

facilities participating in the collection

of medical device-related adverse events

will use this electronic format in

reporting to FDA. The electronic format

will include some additional items that

are not on the 3500A form. These will

be voluntary for participants to

complete, such as hospital profile

information and several questions

related to the use of medical devices.

During this pilot project, FDA is

planning to include the electronic

collection of voluntary information

related to blood products. Currently

blood establishments and transfusion

centers must investigate and keep

records of adverse events regarding

blood or blood products arising as a

result of blood collection or transfusion

(§ 606.170(a) (21 CFR 606.170(a))). In

addition, when the event is fatal, FDA

must be notified immediately (by

phone, fax, express mail, or email) and

a written report must be submitted

within 7 days of the transfusion

(§ 606.170(b). Deviations in the

manufacturing of biological products,

including blood and blood components,

according to the recently published rule

entitled ‘‘Biological Products: Reporting

of Biological Product Deviations in

Manufacturing’’ (November 7, 2000, 65

FR 66621), must also be reported to FDA

when the product is distributed (21 CFR

606.171). The form for these reports is

pending OMB approval.

However, these mandatory reports do

not include errors related to the use of

the product and do not include ‘‘nearmiss’’ errors, an important way of

analyzing weaknesses in the systems.

The ‘‘Medical Event Reporting System

for Transfusion Medicine’’ (MERS–TM)

has been designed to provide this type

of information. For this pilot program,

blood transfusion centers and blood

establishment centers who currently use

9582 Federal Register / Vol. 66, No. 27 / Thursday, February 8, 2001 / Notices

the MERS–TM to track internal events

will be recruited to participate. These

facilities will be asked to fill in the

textual description of the blood-product

related adverse event and to transfer the

two outcome codes from the MERS–TM

concerning problems with blood

products to two additional data fields in

the electronic format that will be

dedicated to collecting this coded

information. FDA will compare the

information obtained in this reporting

system with that obtained under

existing mandatory and voluntary

systems that are in place for transfusionrelated fatalities, product deviations,

and clinical adverse events. FDA will

consider the information that is

voluntarily reported under this pilot

program to design a system that will

assist FDA in gathering the most useful

data, in the least burdensome manner,

for its regulation (including packaging

and labeling provisions) of

establishments and products used in

transfusion medicine.

Participation in this pilot will be

voluntary and will initially include 25

hospitals that will respond to the

medical device questions. At the same

time, an initial nine blood

establishments and transfusion services

sites, which currently use the MERS–

TM, will be recruited to participate. It

is anticipated that during this pilot the

number of participants will increase to

approximately 250 facilities reporting

medical device problems and the

number of blood establishments and

transfusion-services sites is anticipated

to increase to 30. The electronic version

will take approximately 45 minutes, or

less, to complete. For the blood centers

that are participating, the burden of

participation will be approximately 15

minutes.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

Medical devices: 83 15 1,245 .75 934

Blood transfusions: 10 150 1,500 .25 375

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

The number of respondents for

medical devices was determined by the

average number of respondents given

that 25 facilities will be enrolled in the

first year, up to 100 the second year, and

up to 250 the third year. Eighty three is

the average of the final complement of

250 facilities. The annual frequency of

response is based on FDA’s experience

with its mandatory and voluntary

reporting systems.

The number of respondents for blood

transfusions was determined by the

average number of respondents given

that a total of 30 blood establishments

will be enrolled at the end of 3 years.

The annual frequency of response was

based on the information that the

American Red Cross submits about 15

reports per establishment per year. The

MERS–TM will yield about a tenfold

higher than the American Red Cross rate

since it will include close-calls as well

as actual adverse events.

Dated: February 2, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 01–3321 Filed 2–7–01; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0050]

Agency Information Collection

Activities; Proposed Collection;

Comment Request; Medical Devices;

Classification/Reclassification;

Restricted Devices: Premarket

Approval of Medical Devices

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 (the

PRA), Federal agencies are required to

publish notice in the Federal Register

concerning each proposed collection of

information, including each proposed

extension of an existing information

collection, and to allow 60 days for

public comment in response to the

notice. This notice solicits comments on

information collection requirements for

premarket approval of medical devices.

DATES: Submit written or electronic

comments on the collection of

information by April 9, 2001.

ADDRESSES: Submit electronic

comments on the collection of

information to http://

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

dockets/edockethome.cfm. Submit

written comments on the collection of

information to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. All

comments should be identified with the

docket number found in brackets in the

heading of this document.

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:

I. Background

Under the PRA (44 U.S.C. 3501–

3520), Federal agencies must obtain

approval from the Office of Management

and Budget (OMB) for each collection of

information they conduct or sponsor.

‘‘Collection of information’’ is defined

in 44 U.S.C. 3502(3) and 5 CFR

1320.3(c) and includes agency requests

or requirements that members of the

public submit reports, keep records, or

provide information to a third party.

Section 3506(c)(2)(A) of the PRA (44

U.S.C. 3506(c)(2)(A)) requires Federal

agencies to provide a 60-day notice in

the Federal Register concerning each

proposed collection of information,

including each proposed extension of an

existing collection of information,

before submitting the collection to OMB

for approval. To comply with this

requirement, FDA is publishing notice

of the proposed collection of

information set forth in this document.