Federal Register / Vol. 66, No. 43 / Monday, March 5, 2001 / Notices 13331

withdraw, revoke, or limit accreditation

of a laboratory as appropriate and report

the action to HCFA within 30 days.

ASHI also provides an appeal process

for laboratories that have had

accreditation denied, revoked,

suspended, or limited.

We have determined that ASHI’s

laboratory enforcement and appeal

policies are equivalent to the

requirements of this subpart as they

apply to accreditation organizations.

IV. Federal Validation Inspections and

Continuing Oversight

The Federal validation inspections of

ASHI accredited laboratories may be

conducted on a representative sample

basis or in response to substantial

allegations of noncompliance

(complaint inspections). The outcome of

those validation inspections, performed

by HCFA or our agent, or the State

survey agency, will be HCFA’s principal

means for verifying that the laboratories

accredited by ASHI remain in

compliance with CLIA requirements.

This Federal monitoring is an ongoing

process.

V. Removal of Approval as an

Accrediting Organization

Our regulations provide, in part, that

we may remove the approval of an

accreditation organization, such as that

of ASHI, for cause, before the end of the

effective date of approval. If validation

inspection outcomes and the

comparability or validation review

produce findings as described in

§ 493.573 (Continuing Federal oversight

of private nonprofit accreditation

organizations and approved State

licensure programs), HCFA will conduct

a review of an approved accreditation

organization’s program. We also

conduct a review when the validation

review findings, irrespective of the rate

of disparity (as defined in § 493.2

(Definitions)), indicate widespread or

systemic problems in the organization’s

accreditation processes that provide

evidence that the organization’s

requirements, taken as a whole, are no

longer equivalent to the CLIA

requirements, taken as a whole. If

validation inspection results over a 1-

year period indicate a rate of disparity

of 20 percent or more between the

findings of the organization and those of

HCFA, HCFA will conduct a review

under § 493.575(a)(4).

If HCFA determines that ASHI has

failed to adopt or maintain requirements

that are equal to or more stringent than

the CLIA requirements, or systematic

problems exist in its inspection process,

a probationary period as determined by

HCFA, not to exceed 1 year, may be

given to ASHI to adopt equal or more

stringent requirements. HCFA will make

a final determination as to whether or

not ASHI retains its approved status as

an accreditation organization under

CLIA. If approved status is withdrawn,

an accreditation organization such as

ASHI may resubmit its application if it

revises its program to address the

rationale for the withdrawal,

demonstrates that it can reasonably

assure that its accredited laboratories

meet CLIA condition level

requirements, and resubmits its

application for approval as an

accreditation organization in its

entirety. If, however, an approved

accreditation organization requests

reconsideration of an adverse

determination in accordance with

subpart D (Reconsideration of Adverse

Determinations—Deeming Authority for

Accreditation Organizations and CLIA

Exemption of Laboratories Under State

Programs) of part 488 (Survey,

Certification, and Enforcement

Procedures) of our regulations, it may

not submit a new application until

HCFA issues a final reconsideration

determination.

Should circumstances result in ASHI

having its approval withdrawn, HCFA

will publish a notice in the Federal

Register explaining the basis for

removing its approval.

In accordance with the provisions of

Executive Order 12866, this notice was

not reviewed by the Office of

Management of Budget.

Authority: Section 353 of the Public Health

Service Act (42 U.S.C. 263a).

Dated: February 2, 2001.

Michael McMullan,

Acting Deputy Administrator, Health Care

Financing Administration.

[FR Doc. 01–4928 Filed 3–2–01; 8:45 am]

BILLING CODE 4120–01–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 OMB 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.

Comments are invited on: (a) Whether

the proposed collection of information

is necessary for the proper performance

of the functions of the agency, including

whether the information shall have

practical utility; (b) the accuracy of the

agency’s estimate of the burden of the

proposed collection of information; (c)

ways to enhance the quality, utility, and

clarity of the information to be

collected; and (d) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques

or other forms of information

technology.

Proposed Project

Clinical Pharmacy Demonstration

Project Evaluation: NEW

The Clinical Pharmacy Demonstration

Projects, a supplemental grant

opportunity for health center networks,

were established to evaluate the impact

of comprehensive pharmacy services on

the patients served by Health Resources

and Services Administration (HRSA)

supported programs. The overarching

mission is to demonstrate the effect of

implementing comprehensive pharmacy

services in underserved populations. By

collecting data regarding health

outcomes and the level of pharmacy

services provided, the Office of

Pharmacy Affairs hopes to establish the

provision of comprehensive pharmacy

services as a key to improving access

and eliminating health disparities.

The grantee networks will provide

valuable pharmacy services to patients,

and in the process generate data that

will demonstrate the effect of the

projects on health outcomes. Patient

encounter data will be collected

(baseline and semi-annual) for diabetic

patients who receive clinical pharmacy

services. In addition, each participating

pharmacy will complete survey

instruments (baseline, annual) for

utilization, financial, and process data

which describe the program. These data

will result in the following: the creation

of a database to document the

nationwide impact of implementing

comprehensive pharmacy services

through the Clinical Pharmacy

Demonstration Projects in underserved

areas; and, information sources for the

sharing of best practices, with the

ultimate goal of aiding other health

13332 Federal Register / Vol. 66, No. 43 / Monday, March 5, 2001 / Notices

center networks in the implementation

of comprehensive pharmacy services.

The estimated burden is as follows:

Form name Number of

respondents

Responses

per

respondent

Hours per

response

Total

burden

hours

Baseline ........................................................................................................................... 1400 1 .33 462

Encounter data ................................................................................................................ 1400 4 .16 933

Pharmacy Survey ............................................................................................................ 14 3 1 42

Total .......................................................................................................................... 1414 .................... .................... 1437

Send comments to Susan G. Queen,

Ph.D., HRSA Reports Clearance Officer,

Room 14–22, Parklawn Building, 5600

Fishers Lane, Rockville, MD 20857.

Written comments should be received

within 60 days of this notice.

Dated: February 27, 2001.

Jane M. Harrison,

Director, Division of Policy Review and

Coordination.

[FR Doc. 01–5224 Filed 3–2–01; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Submission for OMB Review;

Comment Request; Drug

Accountability Record

SUMMARY: Under the provisions of

section 3507(a)(1)(D) of the Paperwork

Reduction Act of 1995, the National

Cancer Institute (NCI), the National

Institutes of Health (NIH) has submitted

to the Office of Management and Budget

(OMB) a request for review and

approval of the information collection

listed below. This proposed information

collection was previously published in

the Federal Register on December 14,

2000, pages 78175–78176, and allowed

60 days for public comment. No public

comments were received. The purpose

of this notice is to allow an additional

30 days for public comment. The

National Institutes of Health may not

conduct or sponsor, and the respondent

is not required to respond to, an

information collection that has been

extended, revised, or implemented on or

after October 1, 1995, unless it displays

a currently valid OMB control number.

Proposed Collection

Title: Drug Accountability Record.

Type of Information Collection Request:

Revision. (OMB No. 0925–0240, expires

3/31/2001). Need and use of

Information Collection: The regulations

of the Food and Drug Administration

(FDA) require investigators to establish

a record of the receipt, use, and

disposition of all investigational agents.

The National Cancer Institute (NCI), as

a sponsor of investigational drug trials,

has the responsibility for assuring to the

FDA that systems for drug

accountability are being maintained by

investigators in its clinical trials

program. In order to fulfill these

requirements, we have developed two

standardized forms. One, the

investigational Drug Accountability

Report Form (NIH 2564) designed to

account for drug inventories and usage

by protocol and the other, Transfer

Investigational Drug Form (NIH–2564–

1) that permits intra-institutional

transfer of agents to NCI approved

protocols for use by the investigator or

other NCI registered investigators on

approved protocols. The data obtained

from the drug accountability record is

used to track the dispensing of

investigational anticancer drugs from

receipt from NCI to dispensing or

administration to patients. NCI uses the

accountability data to ensure that

investigational drug supplies are not

diverted for inappropriate protocol or

patient use. The drug accountability

information is used to validate patient

protocol reporting forms during site

audits conducted at each of the

Cooperative Groups. The intent is to

ensure the investigational agents are

used according to protocol guidelines

and to ensure the patient’s safety and

protection. Frequency of response:

Daily. Affected public: State or local

governments, businesses or other forprofit, Federal agencies or employees,

non-profit institutions, and small

business or organizations. Types of

Respondents: Investigators and their

designees, pharmacists, nurses,

pharmacy technicians, data managers.

The annual reporting burden is divided

into two major areas. These are the

audits of Drug Accountability Forms by

Government and its contractors and the

use of the forms by clinical research

sites. The burden is as follows: The

annualized respondents’ burden for

record keeping is estimated to require

2,436 hours for drug accountability and

80 hours for drug transfer. The reporting

burden is the average time (4 minutes or

0.0668 hours) required to complete the

transfer investigational drug form

multiplied by the number of forms

completed annually. The record keeping

burden represents an average time

required for multiple entries (4 minutes

or 0.0668 hours per entry) on the drug

accountability form, the average number

of forms maintained by each record

keeper and the number of record

keepers. These estimates are based on

the items shipped by the PMB and the

number of transfer approvals in the

calendar year 1999.

Type of respondents Est. number of

respondents

Est. number of

responses/

respondents

Avg. burden

hours per

response

Avg. burden

hours

Est. total annual burden

hours

requested

Drug transfer, form ............................................................... 1,200 1 0.0668 80 80

Drug, accountability, form .................................................... 4,560 8 0.0668 2,436 2,436

Total .......................................................................... 5,760 ........................ ........................ ........................ 2,516