Federal Register / Vol. 66, No. 105 / Thursday, May 31, 2001 / Notices 29577

GA 30341–4146, Telephone: (770) 488–

2721, Email Address: nfp6@cdc.gov.

For program technical assistance for

the Congressional Glaucoma Caucus

Foundation, contact: Joseph B. Smith,

National Center on Birth Defects and

Developmental Disabilities, 4770 Buford

Highway, NE, MS F–35, Atlanta,

Georgia 30341, Telephone: (770) 488–

7082, Email Address: jos4@cdc.gov.

For program technical assistance for

the Children’s Hospital of Buffalo,

contact: William A. Paradies, National

Center on Birth Defects and

Developmental Disabilities, 4770 Buford

Highway, NE, MS F–45, Atlanta,

Georgia 30341, Telephone: (770) 488–

4704, Email Address: wep2@cdc.gov.

Dated: May 24, 2001.

Henry S. Cassell III

Acting Director, Procurement and Grant

Office, Centers for Disease Control and

Prevention (CDC).

[FR Doc. 01–13616 Filed 5–30–01; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Statement of Organization, Functions,

and Delegations of Authority

Part C (Centers for Disease Control

and Prevention) of the Statement of

Organization, Functions, and

Delegations of Authority of the

Department of Health and Human

Services (45 FR 67772–76, dated

October 14, 1980, and corrected at 45 FR

69296, October 20, 1980, as amended

most recently at 66 FR 20148–20149,

dated April 12, 2001) is amended to

retitle and revise the functional

statement of the Division of Quarantine

(DQ), National Center for Infectious

Diseases (NCID).

Section C–B, Organization and

Functions, is hereby amended as

follows:

Delete in its entirety the title and

functional statement for the Division of

Quarantine (CR2) and insert the

following:

Division of Global Migration and

Quarantine (CR2). (1) Administers a national

quarantine program to protect the United

States against the introduction of diseases

from foreign countries; (2) administers an

overseas program for the medical

examination of immigrants and others with

inadmissible health conditions that would

pose a threat to public health and impose a

burden on public health and hospital

facilities; (3) maintains liaison with and

provides information on quarantine matters

to other Federal agencies, State and local

health departments, and interested

industries; (4) provides liaison with

international health organizations, such as

the Pan American Health Organization and

the World Health Organization, and

participates in the development of

international agreements affecting

quarantine; (5) conducts studies to provide

new information about health hazards

abroad, measures for their prevention, and

the potential threat of disease introduction

into the United States; and (6) provides

logistic support to other programs of the

Centers for Disease Control and Prevention in

the distribution of requested biologicals and

movement of biological specimens through

U.S. ports of entry.

Office of the Director (CR21). (1) Manages

directs, and coordinates the activities of the

Division; (2) provides leadership in

development of Division policy, program

planning, implementation, and evaluation;

(2) identifies needs and resources for new

initiatives and assigns responsibilities for

their development; (4) coordinates liaison

with other Federal agencies, State and local

health departments, and interested

industries; (5) coordinates liaison with

international health organizations; (6)

provides administrative services, including

procurement, property and supply

management, travel arrangements, space and

facilities maintenance, and timekeeper

coordination; (7) provides budgeting and

fiscal management for the Division; (8)

provides personnel support to the Division,

both for Civil Service and Commissioned

Corps employees, and assures that Division

is in compliance with HRMO regulations for

all personnel matters; (9) reviews and

evaluates all administrative services for both

headquarters and Quarantine Stations and

provides policy procedures and guidance on

such matters; (10) provides statistical and

information systems consultation for study

design and protocol development; (11)

provides user and technical support for Local

Area Network (LAN) and other designated

software and hardware, and maintains LAN

and other information systems in accordance

with CDC guidelines; (12) designs and

implements database management systems in

support of Division projects; (13) provides

data analysis and statistical consultation in

support of Division projects; (14) assists in

production of and provides graphics support

for presentations and publications related to

Division objectives; and (15) evaluates new

software and hardware for statistical analysis,

database management, graphics production,

geographic information systems, and other

functions related to Division objectives.

Dated: May 18, 2001.

Jeffrey P. Koplan,

Director.

[FR Doc. 01–13672 Filed 5–30–01; 8:45 am]

BILLING CODE 4160–18–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0063]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request; Medical

Devices; Current Good Manufacturing

Practice Quality System Regulation

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 comments on the

collection of information by July 2,

2001.

ADDRESSES: 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.

Medical Devices; Current Good

Manufacturing Practice (CGMP)

Quality System (QS) Regulation—21

CFR Part 820 (OMB Control No. 0910–

0073)—Extension

Under section 520(f) of the Federal

Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 360j(f)), the Secretary of the

Department of Health and Human

Services has the authority to prescribe

regulations requiring that the methods

used in, and the facilities and controls

used for, the manufacture,

preproduction design validation

(including a process to assess the

performance of a device but not

including an evaluation of the safety

and effectiveness of a device), packing,

storage, and installation of a device

conform to CGMP, as described in such

regulations, to assure that the device

29578 Federal Register / Vol. 66, No. 105 / Thursday, May 31, 2001 / Notices

will be safe and effective and otherwise

in compliance with the act.

The CGMP/QS regulation

implementing the authority provided by

this statutory provision is found in part

820 (21 CFR part 820) of the Code of

Federal Regulations and sets forth basic

CGMP requirements governing the

design, manufacture, packing, labeling,

storage, installation, and servicing of all

finished medical devices intended for

human use. Section 820.20(a) through

(e) requires management with executive

responsibility to establish, maintain,

and/or review: The quality policy; the

organizational structure; the quality

plan; and the quality system procedures

of the organization. Section 820.22

requires the conduct and documentation

of quality system audits and reaudits.

Section 820.25(b) requires the

establishment of procedures to identify

training needs and documentation of

such training.

Section 820.30(a)(1) and (b) through

(j) requires, in the following respective

order, the establishment, maintenance,

and/or documentation of: Procedures to

control design of class III and class II

devices, and certain class I devices as

listed therein; plans for design and

development activities and updates;

procedures identifying, documenting,

and approving design input

requirements; procedures defining

design output, including acceptance

criteria, and documentation of approved

records; procedures for formal review of

design results and documentation of

results in the design history file (DHF);

procedures for verifying device design

and documentation of results and

approvals in the DHF; procedures for

validating device design, including

documentation of results in the DHF;

procedures for translating device design

into production specifications;

procedures for documenting, verifying

and validating approved design changes

before implementation of changes; and

the records and references constituting

the DHF for each type of device.

Section 820.40 requires the

establishment and maintenance of

procedures for the review, approval,

issuance, and documentation of

required records (documents) and

changes to those records.

Section 820.50 requires the

establishment and maintenance of

procedures and requirements to ensure

service and product quality, records of

acceptable suppliers and purchasing

data describing specified requirements

for products and services.

Sections 820.60 and 820.65 require,

respectively, the establishment and

maintenance of procedures for

identifying all products from receipt to

distribution and for using control

numbers to track surgical implants and

life-sustaining or supporting devices

and their components.

Section 820.70(a) through (e), and (g)

through (i) requires the establishment,

maintenance, and/or documentation of:

Process control procedures; procedures

for verifying or validating changes to

specification, method, process, or

procedure; procedures to control

environmental conditions and

inspection result records; requirements

for personnel hygiene; procedures for

preventing contamination of equipment

and products; equipment adjustment,

cleaning and maintenance schedules;

equipment inspection records;

equipment tolerance postings;

procedures for utilizing manufacturing

materials expected to have an adverse

effect on product quality; and validation

protocols and validation records for

computer software and software

changes.

Sections 820.72 and 820.75(a), (b)

introductory text, (b)(2), and (c) require,

respectively, the establishment,

maintenance, and/or documentation of:

Equipment calibration and inspection

procedures; national, international or

in-house calibration standards; records

that identify calibrated equipment and

next calibration dates; validation

procedures and validation results for

processes not verifiable by inspections

and tests; procedures for keeping

validated processes within specified

limits; records for monitoring and

controlling validated processes; and

records of the results of revalidation

where necessitated by process changes

or deviations.

Sections 820.80 and 820.86,

respectively, require the establishment,

maintenance, and/or documentation of:

Procedures for incoming acceptance by

inspection, test or other verification;

procedures for ensuring that in-process

products meet specified requirements

and the control of product until

inspection and tests are completed;

procedures for, and records that show,

incoming acceptance or rejection is

conducted by inspections, tests or other

verifications; procedures for, and

records that show, finished devices

meet acceptance criteria and are not

distributed until device master (DMR)

activities are completed; records in the

device history record (DHR) showing

acceptance dates, results and equipment

used; and the acceptance/rejection

identification of products from receipt

to installation and servicing.

Sections 820.90 and 820.100 require,

respectively, the establishment,

maintenance and/or documentation of:

Procedures for identifying, recording,

evaluating, and disposing of

nonconforming product; procedures for

reviewing and recording concessions

made for, and disposition of,

nonconforming product; procedures for

reworking products, evaluating possible

adverse rework effect and recording

results in the DHR; procedures and

requirements for corrective and

preventive actions, including analysis,

investigation, identification and review

of data, records, causes and results; and

records for all corrective and preventive

action activities.

Sections 820.120(b) and (d), 820.130,

820.140, 820.150, 820.160, and 820.170,

respectively, require the establishment,

maintenance, and/or documentation of:

Procedures for controlling and recording

the storage, examination, release and

use of labeling; the filing of labels/

labeling used in the DHR; procedures

for controlling product storage areas and

receipt/dispatch authorizations;

procedures for controlling the release of

products for distribution; distribution

records that identify consignee, product,

date and control numbers; and

instructions, inspection and test

procedures that are made available, and

the recording of results for devices

requiring installation.

Sections 820.180(b) and (c), 820.181,

820.184, and 820.186 require,

respectively, the maintenance of

records: That are retained at prescribed

site(s), made readily available and

accessible to FDA and retained for the

device’s life expectancy or for 2 years;

that are contained or referenced in a

DMR consisting of device, process,

quality assurance, packaging and

labeling, and installation, maintenance,

and servicing specifications and

procedures; that are contained in DHRs,

demonstrate the manufacture of each

unit, lot or batch of product in

conformance with DMR and regulatory

requirements, and include

manufacturing and distribution dates

and quantities, acceptance documents,

labels and labeling, and control

numbers; and that are contained in a

quality system record (QSR) consisting

of references, documents, procedures,

and activities not specific to particular

devices.

Sections 820.198(a) through (c) and

820.200(a) and (d), respectively, require

the establishment, maintenance and/or

documentation of: Complaint files and

procedures for receiving, reviewing, and

evaluating complaints; complaint

investigation records identifying the

device, complainant, and relationship of

the device to the incident; complaint

records that are reasonably accessible to

the manufacturing site or at prescribed

sites; procedures for performing and

Federal Register / Vol. 66, No. 105 / Thursday, May 31, 2001 / Notices 29579

verifying that device servicing

requirements are met and that service

reports involving complaints are

processed as complaints; and service

reports that record the device, service

activity, and test and inspection data.

Section 820.250 requires the

establishment and maintenance of

procedures to identify valid statistical

techniques necessary to verify process

and product acceptability; and sampling

plans, when used, that are written and

based on a valid statistical rationale,

and procedures for ensuring adequate

sampling methods.

The CGMP/QS regulation amends and

revises the CGMP requirements for

medical devices set out at part 820. It

adds design and purchasing controls;

modifies previous critical device

requirements; revises previous

validation and other requirements; and

harmonizes device CGMP requirements

with quality system specifications in the

international standard, ISO

(International Organization for

Standardization) 9001:1994 ‘‘Quality

Systems—Model for Quality Assurance

in Design, Development Production,

Installation and Servicing.’’ The rule

does not apply to manufacturers of

components or parts of finished devices,

nor to manufacturers of human blood

and blood components subject to 21

CFR part 606. With respect to devices

classified in class I, design control

requirements apply only to class I

devices listed in § 820.30(a)(2) of the

regulation.

The rule imposes burdens upon

finished device manufacturer firms,

which are subject to all recordkeeping

requirements, and upon finished device

contract manufacturer, specification

developer, repacker and relabeler, and

contract sterilizer firms, which are

subject only to requirements applicable

to their activities. Due to modifications

to the guidance given for

remanufacturers of hospital single use

devices, reusers of hospital single-use

devices will now be considered to have

the same requirements as manufacturers

in regard to this regulation. The

establishment, maintenance, and/or

documentation of procedures, records

and data required by this final

regulation will assist FDA in

determining whether firms are in

compliance with CGMP requirements,

which are intended to ensure that

devices meet their design, production,

labeling, installation, and servicing

specifications and, thus are safe,

effective, and suitable for their intended

purpose. In particular, compliance with

CGMP design control requirements

should decrease the number of designrelated device failures that have resulted

in deaths and serious injuries.

If FDA did not impose these

recordkeeping requirements, it

anticipates that design-related device

failures would continue to occur in the

same numbers as before and continue to

result in a significant number of device

recalls and preventable deaths and

serious injuries. Moreover,

manufacturers would be unable to take

advantage of substantial savings

attributable to reduced recall costs,

improved manufacturing efficiency, and

improved access to international

markets through compliance with

CGMP requirements that are

harmonized with international quality

system standards.

The CGMP/QS regulation applies to

some 9,229 respondents. These

recordkeepers consist of 7,229 original

respondents and an estimated 2,000

hospitals that remanufacture or reuse

single use medical devices. They

include manufacturers, subject to all

requirements and contract

manufacturers, specification developers,

repackers/relabelers and contract

sterilizers, subject only to requirements

applicable to their activities. Hospital

remanufacturers of single use medical

devices (SUDs) are now defined to be

manufacturers under guidelines issued

by the Center for Devices and

Radiological Health’s (CDRHs) Office of

Surveillance and Biometrics.

Respondents to this collection have no

reporting activities, but must make

required records available for review or

copying during FDA inspection. The

regulation contains additional

recordkeeping requirements in such

areas as design control, purchasing,

installation, and information relating to

the remanufacture of single use medical

devices. The estimates for burden are

derived from those incremental tasks

that were determined when the new

CGMP/QS regulation became final

(October 7, 1996, 61 FR 52602) as well

as those carry-over requirements. The

carry-over requirements are based on

decisions made by the agency on July

16, 1992, under OMB Paperwork

Reduction Act submission No. 0910–

0073. This still provides valid baseline

data.

FDA estimates respondents will have

a total annual recordkeeping burden of

approximately 3,167,670 hours (shown

as 3,167,670 in table 1, of this

document, of this justification statement

due to rounding). This figure also

consists of approximately 114,882 hours

spent on a startup basis by 650 new

firms. Table 1 of this document

identifies burden estimates per sections

of the regulation.

In the Federal Register of February

28, 2001 (66 FR 12798), the agency

requested comments on the proposed

collection of information. No comments

were received.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of

Recordkeepers

Annual Frequency

per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

Total Operating

and Maintenance

Costs

820.20(a) 9,229 1 9,229 6.58 60,727

820.20(b) 9,229 1 9,229 4.43 40,884

820.20(c) 9,229 1 9,229 6.17 56,943

820.20(d) 9,229 1 9,229 9.89 91,275

820.20(e) 9,229 1 9,229 9.89 91,275

820.22 9,229 1 9,229 32.72 301,973

820.25(b) 9,229 1 9,229 12.68 117,024

820.30(a)(1) 9,229 1 9,229 1.75 16,151

820.30(b) 9,229 1 9,229 5.95 54,913

820.30(c) 9,229 1 9,229 1.75 16,151

820.30(d) 9,229 1 9,229 1.75 16,151

820.30(e) 9,229 1 9,229 23.39 215,866

820.30(f) 9,229 1 9,229 37.42 345,349

820.30(g) 9,229 1 9,229 37.42 345,349

820.30(h) 9,229 1 9,229 3.34 30,825

29580 Federal Register / Vol. 66, No. 105 / Thursday, May 31, 2001 / Notices

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1—Continued

21 CFR Section No. of

Recordkeepers

Annual Frequency

per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

Total Operating

and Maintenance

Costs

820.30(i) 9,229 1 9,229 17.26 159,293

820.30(j) 9,229 1 9,229 2.64 24,365

820.402 9,229 1 9,229 8.91 82,230

820.40(a) and (b) 9,229 1 9,229 2.04 18,827

820.50(a)(1)

through (a)(3) 9,229 1 9,229 21.9 202,115 $1,181,925

820.50(b) 9,229 1 9,229 6.02 55,559

821.60 9,229 1 9,229 0.32 2,953

821.65 9,229 1 9,229 0.67 6,183

820.70(a)(1)

through (a)(5) 9,229 1 9,229 1.85 17,074

820.70(b) and (c) 9,229 1 9,229 1.85 17,074

820.70(d) 9,229 1 9,229 2.87 26,487

820.70(e) 9,229 1 9,229 1.85 17,074

820.70(g)(1)

through (g)(3) 9,229 1 9,229 1.43 13,197

820.70(h) 9,229 1 9,229 1.85 17,074

820.70(i) 9,229 1 9,229 7.5 69,218

820.72(a) 9,229 1 9,229 4.92 45,407

820.72(b)(1) and

(b)(2) 9,229 1 9,229 1.43 13,197

820.75(a) 9,229 1 9,229 2.69 24,826

820.75(b) 9,229 1 9,229 1.02 9,414

820.75(c) 9,229 1 9,229 1.11 10,244

820.80(a) through

(e) 9,229 1 9,229 4.8 44,299

820.86 9,229 1 9,229 0.79 7,291

820.90(a) 9,229 1 9,229 4.95 45,684

820.90(b)(1) and

(b)(2) 9,229 1 9,229 4.95 45,684

820.100(a)(1)

through (a)(7) 9,229 1 9,229 12.48 115,178

820.100(b) 9,229 1 9,229 1.28 11,813

820 9,229 1 9,229 0.45 4,153

820.120(b) 9,229 1 9,229 0.45 4,153

820.120(d) 9,229 1 9,229 0.45 4,153

820.1302 9,229 1 9,229 0.45 4,153

820.1402 9,229 1 9,229 6.34 58,512

820.150(a) and

(b) 9,229 1 9,229 5.67 52,328

820.160(a) and

(b) 9,229 1 9,229 0.67 6,183

820.170(a) and

(b) 9,229 1 9,229 1.5 13,844

820.180(b) and

(c) 9,229 1 9,229 1.5 13,844

820.181(a)

through (e) 9,229 1 9,229 1.21 11,167

820.184(a)

through (f) 9,229 1 9,229 1.41 13,013

820.186 9,229 1 9,229 0.4 3,692

820.198(a)

through (c) 9,229 1 9,229 4.94 45,591

820.200(a) and

(d) 9,229 1 9,229 2.61 24,088

820.250 9,229 1 9,229 0.67 6,183

Total 3,167,673 $1,181,925

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

The typographical errors that appeared in

tabel 1 of a notice published in the Federal

Register of February 28, 2001 (66 FR 12798

at 12801), are corrected in this document as

follows: ‘‘820.4’’ is corrected to read

‘‘820.40’’; and part ‘‘821’’, which appeared

twice, is corrected to read ‘‘820.60’’ and

‘‘820.65’’, respectively.

Burden (labor) hour and cost

estimates were developed under FDA

contract by the Eastern Research Group,

Inc. (ERG), in 1996 when the CGMP/QS

regulation became final. These figures

are still accurate. Additional factors

considered in deriving estimates

included:

• Establishment type: Query has been

made of CDRHs registration/listing

Federal Register / Vol. 66, No. 105 / Thursday, May 31, 2001 / Notices 29581

data bank and has counted 7,229

domestic firms subject to CGMPs.

They were then grouped as:

Manufacturers (5,463), contract

manufacturers (204), specification

developers (960), repackers/

relabelers (574), remanufacturer

(21) and contract sterilizers (7). In

addition, hospitals that reuse or

remanufacture devices are now

considered manufacturers under

new FDA guidance. It is estimated

that out of the 6,000 hospitals in the

United States, one-third of them (or

2,000 hospitals) will reuse or

remanufacture single use medical

devices. Thus, the number of

manufacturers will increase from

5,463 to 7,463 making the total

number of firms subject to CGMPs

9,229.

• Potentially affected establishments:

Except for manufacturers, not every

type of firm is subject to every

CGMP/QS requirement. For

example, all are subject to quality

policy (§ 820.20(a)), document

control (§ 820.40), and other

requirements, whereas only

manufacturers and specification

developers are subject to part 820

Subpart C—Design Controls. The

type of firm subject to each

requirement was identified by ERG.

FDA estimated the burden hours (and

costs) for the previous CGMP regulation

in 1992. That estimate was submitted to

OMB on May 4, 1992, under OMB

Paperwork Reduction Act submission

No. 0910–0073. It was approved by

OMB on July 16, 1992, and it expired on

June 30, 1995. The methodology used is

different than that used by ERG in

estimating incremental tasks when the

new CGMP/QS became a final rule.

Nevertheless, the agency believes its

1992 estimate adequately represents

labor hours (and costs) needed to

comply with previous CGMP

requirements carried over into the new

CGMP/QS regulation. The 1992 estimate

used 9,289 respondents (rather than

9,229 respondents), which compensates

for differences in methodology.

FDA estimates that some 650 ‘‘new’’

establishments (marketing devices for

the first time) will expend some 114,882

‘‘development’’ hours on a one-time

startup basis to develop records and

procedures for the CGMP/QS regulation.

FDA estimates that annual labor hours

are apportioned as follows: 40 percent—

to requirements dealing with

manufacturing specifications, process

controls and the DHR; 20 percent—to

requirements dealing with components

and acceptance activities; 25 percent—

to requirements dealing with

equipment, records (the DMR and QSR),

complaint investigations, labeling/

packaging and reprocessing/

investigating product nonconformance;

and 15 percent—to quality audit,

traceability, handling, distribution,

statistical, and other requirements.

Dated: May 23, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–13655 Filed 5–30–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–10030]

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

AGENCY: Health Care Financing

Administration, HHS.

In compliance with the requirement

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

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding this burden

estimate or any other aspect of this

collection of information, including any

of the following subjects: (1) The

necessity and utility of the proposed

information collection for the proper

performance of the agency’s functions;

(2) the accuracy of the estimated

burden; (3) ways to enhance the quality,

utility, and clarity of the information to

be collected; and (4) the use of

automated collection techniques or

other forms of information technology to

minimize the information collection

burden.

Type of Information Collection

Request: New Collection; Title of

Information Collection: National

Medicare Practitioner and Provider

Survey; Form No.: HCFA–10030 (OMB#

0938–NEW); Use: Under the Medicare

Integrity Program, established by the

Health Insurance Portability and

Accountability Act of 1996, HCFA was

instructed to promote the integrity of

the Medicare program by, among other

things, education providers of services

about payment integrity and benefit

quality assurance issues. HCFA needs

this information to design a national

education plan aimed at reducing

inadvertent errors caused by a lack of

understanding of Medicare Rules and

Regulations. The information will assist

HCFA in creating high quality,

accessible educational opportunities to

help Medicare providers, practitioners,

office staff and billing agents decrease

unintentional errors on Medicare

claims.; Frequency: Other: One-time

only; Affected Public: Business or other

for-profit; Number of Respondents:

9,000; Total Annual Responses: 9,000;

Total Annual Hours: 3,600.

To obtain copies of the supporting

statement and any related forms for the

proposed paperwork collections

referenced above, access HCFA’s Web

Site address at http://www.hcfa.gov/

regs/prdact95.htm, or E-mail your

request, including your address, phone

number, OMB number, and HCFA

document identifier, to

Paperwork@hcfa.gov, or call the Reports

Clearance Office on (410) 786–1326.

Written comments and

recommendations for the proposed

information collections must be mailed

within 30 days of this notice directly to

the OMB desk officer: OMB Human

Resources and Housing Branch,

Attention: Wendy Taylor, New

Executive Office Building, Room 10235,

Washington, DC 20503.

Dated: May 9, 2001.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA Office

of Information Services, Security and

Standards Group, Division of HCFA

Enterprise Standards.

[FR Doc. 01–13651 Filed 5–30–01; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Agency Information Collection

Activities: Proposed Collection;

Comment Request

In compliance with the requirement

for opportunity for public comment on

proposed data collection projects

(section 3506(c)(2)(A) of title 44, United

States Code, as amended by the

Paperwork Reduction Act of 1995,

Public Law 104–13), the Health

Resources and Services Administration

(HRSA) publishes periodic summaries

of proposed projects being developed

for submission to the Office of

Management and Budget under the

Paperwork Reduction Act of 1995. To

request more information on the

proposed project or to obtain a copy of

the data collection plans and draft

instruments, call the HRSA Reports

Clearance Officer on (301) 443–1129.