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.