Federal Register / Vol. 66, No. 82 / Friday, April 27, 2001 / Notices 21161

information on electronic access to the

guidance.

FOR FURTHER INFORMATION CONTACT:

Doria DuBois, Center for Devices and

Radiological Health (HFZ–440), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–2096.

SUPPLEMENTARY INFORMATION:

I. Background

On February 12, 1998, FDA called a

meeting of the Microbiology Devices

Advisory Panel to obtain

recommendations from the panel

regarding scientific information

necessary for premarket approval of

tests for hepatitis viruses. Following the

panel meeting and subsequent

discussions between FDA and industry,

FDA developed and published a draft

guidance (See 64 FR 54902, October 8,

1999). FDA accepted public comments

regarding the draft guidance until

January 6, 2000. This second draft

guidance incorporates those comments

and replaces the October 8, 1999, draft

guidance document.

II. Significance of Guidance

This draft guidance document

represents the agency’s current thinking

on assays for detecting evidence of

infection with HCV. It does not create or

confer any rights for or on any person

and does not operate to bind FDA or the

public. An alternative approach may be

used if such approach satisfies the

applicable statutes and regulations.

The agency has adopted good

guidance practices (GGPs) and

published the final rule, which set forth

the agency’s regulations for the

development, issuance, and use of

guidance documents (65 FR 56468,

September 19, 2000). This draft

guidance document is issued as a level

1 guidance in accordance with the GGP

regulations.

III. Electronic Access

In order to receive ‘‘Premarket

Approval Applications for In Vitro

Diagnostic Devices Pertaining to

Hepatitis C Viruses (HCV): Assays

Intended for Diagnosis, Prognosis, or

Monitoring of HCV Infection, Hepatitis

C, or Other HCV-Associated Disease;

Draft Guidance for Industry and FDA’’

via your fax machine, call the CDRH

Facts-On-Demand system at 800–899–

0381 or 301–827–0111 from a touchtone telephone. Press 1 to enter the

system. At the second voice prompt

press 1 to order a document. Enter the

document number (1353) followed by

the pound sign (#). Follow the

remaining voice prompts to complete

your request.

Persons interested in obtaining a copy

of the draft guidance may also do so

using the Internet. CDRH maintains an

entry on the Internet for easy access to

information including text, graphics,

and files that may be downloaded to a

personal computer with Internet access.

The CDRH home page may be accessed

at http://www.fda.gov/cdrh. ‘‘Premarket

Approval Applications for In Vitro

Diagnostic Devices Pertaining Hepatitis

C Viruses (HCV): Assays Intended for

Diagnosis, Prognosis, or Monitoring of

HCV Infection or HCV-Associated

Disease; Draft Guidance for Industry and

FDA,’’ will be available at http://

www.fda.gov/cdrh/ode/guidance/

1353.pdf. Updated on a regular basis,

the CDRH home page also includes the

civil money penalty guidance

documents package, device safety alerts,

Federal Register reprints, information

on premarket submissions (including

lists of approved applications and

manufacturers’ addresses), small

manufacturers’ assistance, information

on video conferencing and electronic

submissions, mammography matters,

and other device-oriented information.

IV. Comments

Interested persons may submit to

Dockets Management Branch (address

above) written comments regarding this

draft guidance by July 26, 2001. Two

copies of any comments are to be

submitted, except individuals may

submit one copy. Comments are to be

identified with the docket number

found in brackets in the heading of this

document. The guidance document and

received comments may be seen in the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

Dated: April 18, 2001.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 01–10528 Filed 4–26–01; 8:45 am]

BILLING CODE 4160–01–S

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, Pub.

L. 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) 443–1891.

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: Evaluation of the

Health Care for the Homeless Respite

Pilot Initiative—New

The Bureau of Primary Health Care

(BPHC), Health Resources Services

Administration (HRSA), proposes to

conduct an evaluation of the Health

Care for the Homeless (HCH) Respite

Pilot Initiative. Data will be collected

from the ten HCH grantees participating

in the Pilot Initiative. The evaluation

will be developed and conducted by the

National Health Care for the Homeless

Council through a cooperative

agreement with the BPHC. The focus of

the evaluation will be on assessing the

effect of respite services on the health of

homeless people as well as looking at

any differences in outcomes based on

client or program characteristics. The

evaluation will be conducted

throughout the three-year period of the

Pilot Initiative.

The estimated response burden is as

follows:

21162 Federal Register / Vol. 66, No. 82 / Friday, April 27, 2001 / Notices

Type of

respondent

Number of

respondents

Response per

respondents

Hours per

response

Total hour

burden

HCH Grantees .................................................................................................. 10 600 0.25 1500

Send comments to Susan G. Queen,

Ph.D., HRSA Reports Clearance Officer,

Room 14–33, Parklawn Building, 5600

Fishers Lane, Rockville, MD 20857.

Written comments should be received

on or before June 26, 2001.

Dated: April 23, 2001.

Jane M. Harrison,

Director, Division of Policy Review and

Coordination.

[FR Doc. 01–10529 Filed 4–26–01; 8:45 am]

BILLING CODE 4160–15–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

Periodically, the Health Resources

and Services Administration (HRSA)

publishes abstracts of information

collection requests under review by the

Office of Management and Budget, in

compliance with the Paperwork

Reduction Act of 1995 (44 U.S.C.

Chapter 35). To request a copy of the

clearance requests submitted to OMB for

review, call the HRSA Reports

Clearance Office on (301)–443–1129.

The following request has been

submitted to the Office of Management

and Budget for review under the

Paperwork Reduction Act of 1995:

Proposed Project: Uniform Data

System (OMB No. 0915–0193)—

Revision—This is a request for revision

of approval of the Uniform Data System

(UDS), which contains the annual

reporting requirements for the cluster of

primary care grantees funded by the

Bureau of Primary Health Care (BPHC),

Health Resources and Services

Administration (HRSA). The UDS

includes reporting requirements for

grantees of the following primary care

programs: Community Health Centers,

Migrant Health Centers, Health Care for

the Homeless, Outreach and Primary

Health Services for Homeless Children

and Public Housing Primary Care.

Authorizing Legislation is found in

Public Law 104–299, Health Center

Consolidation Act of 1996, enacting

Section 330 of the Public Health Service

Act.

The Bureau of Primary Health Care

collects data on its programs to ensure

compliance with legislative mandates

and to report to Congress and

policymakers on program

accomplishments. To meet these

objectives, BPHC requires a core set of

information collected annually that is

appropriate for monitoring and

evaluating performance and reporting

on annual trends. The UDS includes

two components: the Universal Report,

completed by all grantees, provides data

on services, staffing, and financing; and

the Grant Report, completed by grantees

funded under the Homeless or Public

Housing Program as well as one of the

other programs, provides data on

characteristics of users whose services

fall within the scope of the Homeless or

Public Housing Program grant. Grantees

are also asked to provide information on

the charges, collections, bad debt write

off and contractual disallowances by

payor sources (Medicaid, Medicare, self

pay and private insurance). In addition,

grantees need to include categories to

some of the lists (e.g., services, ICD

codes, CPT codes) and annotating the

forms to indicate which lines are

subtotals and the lines to which they

sum.

Estimates of annualized reporting

burden are as follows:

Type of report Number of respondents

Hours per responseTotal burden

hours

Universal ...................................................................................................................................... 712 24 17,088

Grant ............................................................................................................................................ 96 16 1,536

Total .......................................................................................................................................... 712 18,624

Written comments and

recommendations concerning the

proposed information collection should

be sent within 30 days of this notice to:

John Morrall, Human Resources and

Housing Branch, Office of Management

and Budget, New Executive Office

Building, Room 10235, Washington, DC

20503.

Dated: April 23, 2001.

Jane M. Harrison,

Director, Division of Policy Review and

Coordination.

[FR Doc. 01–10531 Filed 4–26–01; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Federal Assistance to the Columbia

Hospital for Women Medical Center

Community Outreach Programs

AGENCY: Health Resources and Services

Administration, HHS.

ACTION: Notice of grant award.

SUMMARY: The Maternal and Child

Health Bureau (MCHB), Health

Resources and Services Administration

(HRSA), awarded a grant for $5 million

in fiscal year (FY) 2001 to Columbia

Hospital for Women Medical Center, in

Washington, DC. The grant supports

community outreach programs for

women. The award was made from

funds appropriated under Public Law

106–554 (HHS Appropriation Act for FY

2001). As part of MCHB’s overall

appropriation, monies were specifically

designated to support the Columbia

Hospital for Women Medical Center

project. The grant for the project is a

Special Project of Regional and National

Significance authorized by section

501(a)(2) of the Social Security Act, the

Maternal and Child Health Federal SetAside Program.

SINGLE SOURCE JUSTIFICATION: The HRSA

is providing Federal financial assistance

to the Columbia Hospital for Women

Medical Center to support infrastructure

development of community outreach

programs for women (and their high risk

infants), to: (1) Maintain capacity and

increase coordination of primary care

and preventive services for women and

high risk infants who have limited