Federal Register / Vol. 66, No. 118 / Tuesday, June 19, 2001 / Notices 32953

requirements, and certification that

projects have been reviewed by the IRB.

Respondents: Individuals, Business or

other for-profit, Non-profit institutions,

Federal, State, Local or Tribal

Governments.

Section of rule and description Annual No. of

responses

Hours per

response Total burden

.103(a), .103(b) and .103(c)—assurances and underlying written policies and procedures .... 2,100 40 84,000

.103(b)(3)—report change in IRB membership ......................................................................... 250 .083 20

.103(b)(5)—report problems, terminations, suspensions .......................................................... 42 8 336

.103(f)—certification ................................................................................................................... 26,600 .083 2,208

.103(b)(4)(i) and .109(d)—IRB disclosure of actions ................................................................ 38,000 1 38,000

.103(b)(4)(ii)—proposed changes reported to IRB .................................................................... 250 .083 20

.103(b)(5)—problems disclosed to IRB and institution .............................................................. 15 8 120

.113—notice of suspension of IRB approval ............................................................................. 30 8 240

.116 and .117—informed consent ............................................................................................. 140,000 .25 35,000

.115(a)—IRB recordkeeping ...................................................................................................... 23,000 1 23,000

Total ................................................................................................................................ ........................ .......................... 182,944

Proposed Project 3. Optional Form

310: Protection of Human Subjects

Assurance Identification/IRB

Certification/Declaration of

Exemption—This form may be used by

Federal agencies to implement the

requirement of the Common Rule which

requires that institutions submitting

applications for Federal support of

research involving human subjects

submit certification of appropriate

Institutional Review Board review and

approval (Section _.103(f) of the

Common Rule). The burden associated

with this form is included in the table

above.

Please send comments to Cynthia

Agens Bauer, OS Reports Clearance

Officer, Room 503H, Humphrey

Building, 200 Independence Avenue

SW., Washington DC, 20201. Written

comments should be received within 60

days of this notice.

Dated: June 13, 2001.

Kerry Weems,

Acting Deputy Assistant Secretary, Budget.

[FR Doc. 01–15405 Filed 6–18–01; 8:45 am]

BILLING CODE 4150–28–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Committee on Vital and Health

Statistics: Meeting

Pursuant to the Federal Advisory

Committee Act, the Department of

Health and Human Services announces

the following advisory committee

meeting.

Name: National Committee on Vital and

Health Statistics (NCVHS), Subcommittee on

Standards and Security.

Time and Date: 9:00 a.m. to 5:00 p.m., June

26, 2001.

Place: Renaissance Hotel, 999 9th Street,

NW., Washington, DC, (202) 898–9000.

Status: Open.

Purpose: At this working session, the

Subcommittee on Standards and Security

will complete their assessment of the

modifications to transaction standards and

final rules recommended by the Designated

Standards Maintenance Organizations, and of

general industry HIPAA readiness.

Recommendations to the Secretary will be

drafted for full committee review.

Contact person for more information:

Substantive program information as well as

summaries of meetings and a roster of

committee members may be obtained from J.

Michael Fitzmaurice, Ph.D., Senior Science

Advisor for Information Technology, Agency

for Health Care Research and Quality, 2101

East Jefferson Street, #600, Rockville, MD

20852, phone: (301) 594–3938; or Marjorie S.

Greensberg, Executive Secretary, NCVHS,

National Center for Health Statistics, Centers

for Disease Control and Prevention, Room

1100, Presidential Building, 6525 Belcrest

Road, Hyattsville, Maryland 20782,

telephone (301) 458–4245. Information also

is available on the NCVHS home page of the

HHS website: http://www.ncvhs.hhs.gov/

where an agenda for the meeting will be

posted when available.

Dated: June 7, 2001.

James Scanlon,

Director, Division of Data Policy, Office of

the Assistant Secretary for Planning and

Evaluation.

[FR Doc. 01–15364 Filed 6–18–01; 8:45 am]

BILLING CODE 4151–05–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Agency for Healthcare Research and

Quality

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Agency for Healthcare Research

and Quality, HHS.

ACTION: Notice.

SUMMARY: This notice announces the

intention of the Agency for Healthcare

Research and Quality (AHRQ) to request

the Office of Management and Budget

(OMB) to allow a proposed information

collection project: ‘‘Primary Care

Network Survey (PRINS)’’. In

accordance with the Paperwork

Reduction Act as amended (see in

particular 44 U.S.C. 3506(c)(2)(A)),

AHRQ invites the public to comment on

this proposed information collection

request to allow AHRQ to conduct

research in primary care settings.

DATES: Comments on this notice must be

received by August 20, 2001.

ADDRESSES: Written comments should

be submitted to: Cynthia D. McMichael,

Reports Clearance Officer, AHRQ, 2101

East Jefferson Street, Suite 500,

Rockville, MD 20852–4908.

All comments will become a matter of

public record.

FOR FURTHER INFORMATION CONTACT:

Cynthia D. McMichael, AHRQ, Reports

Clearance Officer, (301) 594–3132.

SUPPLEMENTARY INFORMATION:

Primary Care Network Survey (PRINS)

As directed in its reauthorization

legislation, AHRQ supports activities

designed to improve the capacity of

practice-based research networks

(PBRNs) to conduct research in primary

care settings. A PBRN is a group of

ambulatory practices devoted

principally to the primary care of

patients, affiliated with each other in

order to investigate questions related to

community-based practice. AHRQ has

recently established cooperative

agreements with 19 PBRNs who have

specifically been asked to conduct

network-defining surveys using the

1999–2000 version of the National

Ambulatory Medicare Care Survey

(NAMCS) instrument (OMB No. 0920–

0234). To distinguish data collected

through the survey from NAMCS data

collected from the nationally

representative physician sample of the

National Center for Health Statistics,

32954 Federal Register / Vol. 66, No. 118 / Tuesday, June 19, 2001 / Notices

CDC, this survey will be known as the

Primary Care Network Survey (PRINS).

Method of Collection

PRINS will provide a range of

baseline data on the clinicians enrolled

in each network, the services provided,

and the characteristics of patients

receiving those services. Data to be

collected include the patients’

demographic characteristics and

reason(s) for visit, and the providers’

diagnosis(es) and diagnostic services,

medications and disposition. These data

may be used by the PBRN to define the

network’s capacity to study specific

clinical conditions seen in primary care,

establish a denominator for

epidemiological or surveillance studies,

and stimulate further research on the

use, organization and delivery of

primary care. All identifiable data that

is collected will be protected in

accordance with the AHRQ

confidentiality statute, 42 U.S.C 299c–

3(c).

The estimated annual hour burden is

as follows:

Form

Number of

respondents

(clinicians)

Number of forms/

respondent

Avg. burden/form

(in hrs)

Response burden

(hrs)

(1) (2) (3) (1)*(2)*(3) 1

Intake Form .............................................................................. 1,000 1 .25 250

Patient Form ............................................................................ 1,000 30 .03 900

Total .............................................................................. 1,000 31 1.15 1,150

1For rows 1 and 2.

To calculate the burden hours, the

number of respondents for PRINS is

based on a sample of 1,000 clinicians

who have agreed in advance to

participate. Each clinician fills out an

intake form (which requires about 15

minutes).

The same 1,000 then record (on

separate forms) information about 30

consecutive patients seen in his/her

practice (requiring less than 2 minutes

per form to complete). The total cost to

respondents is estimated to be $150,000.

Request for Comments

Comments are invited on: (a) The

necessity of the proposed collections;

(b) the accuracy of the Agency’s

estimate of burden (including hours and

cost) 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 upon the

respondents, including the use of

automated collection techniques or

other forms of information technology.

Comments submitted in response to

this notice will be summarized and

included in the request for OMB

approval of the proposed information

collection. All comments will become a

matter of public record.

Copies of these proposed collection

plans and instruments can be obtained

from the AHRQ Reports Clearance

Officer (see above).

Dated: June 8, 2001.

Carolyn Clancy,

Acting Director.

[FR Doc. 01–15288 Filed 6–18–01; 8:45 am]

BILLING CODE 4160–90–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Agency for Toxic Substances and

Disease Registry

[Program Announcement 01124]

Assess Human Exposures to

Contaminants Near Kelly Air Force

Base, Texas; Notice of Availability of

Funds

A. Purpose

The Agency for Toxic Substances and

Disease Registry (ATSDR) announces

the availability of fiscal year (FY) 2001

funds for a grant to address community

health concerns through evaluating the

health status, evaluating potential

exposures, and providing health

education to the community

surrounding Kelly Air Force Base,

Texas. This program address the

‘‘Health People 2010’’ focus area of

Environmental Health.

The purpose of the program is to

assist the San Antonio Metropolitan

Health District (SAMHD) in addressing

the health concerns of the community

and providing health education to the

residents. These site-specific health

activities should target area residents

and surrounding communities and

address site-specific health concerns.

Results of any clinical assessments will

be provided to individual participants

to address their own personal health

concerns.

B. Eligible Applicants

Assistance will be provided only to

the San Antonio Metropolitan Health

District (SAMHD). No other applications

are solicited. Eligibility is limited to the

SAMHD because fiscal year 2001

Federal appropriation specifically

directs CDC to award the district to

address community concerns around

Kelly Air Force Base, Texas.

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 $177,729 is available

in FY 2001 to fund this award. it is

expected that the award 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 one

year. Funding estimates may change.

Use of Funds

Funds may be expended for

reasonable program purposes, such as

personnel, travel, supplies, and services.

Funds for contractual services may be

requested; however, the grantee, as the

direct and primary recipient of grant

funds, must perform a substantive role

in carrying out project activities and not

merely serve as a conduit for an award

to another party or provide funds to an

ineligible party. Requests for equipment

purchases will be reviewed and

approved only under the following

conditions: (1) ATSDR retains the right

to request return of all equipment

purchased (in operable condition) with

grant funds at the conclusion of the

project period, and (2) equipment

purchased must be compatible with

ATSDR hardware. Computers purchased

with ATSDR funds should be IMB

compatible and adhere to the Centers for

Disease Control and Prevention (CDC)/

ATSDR hardware standards.