4304 Federal Register / Vol. 62, No. 19 / Wednesday, January 29, 1997 / Notices

Doppler signal (blood flow), and

visualize wall motion of the heart.

Closed committee deliberations. FDA

staff will present to the committee trade

secret and/or confidential commercial

information regarding present and

future FDA issues. This portion of the

meeting will be closed to permit

discussion of this information (5 U.S.C.

552b(c)(4)).

Each public advisory committee

meeting listed above may have as many

as four separable portions: (1) An open

public hearing, (2) an open committee

discussion, (3) a closed presentation of

data, and (4) a closed committee

deliberation. Every advisory committee

meeting shall have an open public

hearing portion. Whether or not it also

includes any of the other three portions

will depend upon the specific meeting

involved. The dates and times reserved

for the separate portions of each

committee meeting are listed above.

The open public hearing portion of

the meeting(s) shall be at least 1 hour

long unless public participation does

not last that long. It is emphasized,

however, that the 1 hour time limit for

an open public hearing represents a

minimum rather than a maximum time

for public participation, and an open

public hearing may last for whatever

longer period the committee

chairperson determines will facilitate

the committee’s work.

Public hearings are subject to FDA’s

guideline (subpart C of 21 CFR part 10)

concerning the policy and procedures

for electronic media coverage of FDA’s

public administrative proceedings,

including hearings before public

advisory committees under 21 CFR part

14. Under 21 CFR 10.205,

representatives of the electronic media

may be permitted, subject to certain

limitations, to videotape, film, or

otherwise record FDA’s public

administrative proceedings, including

presentations by participants.

Meetings of advisory committees shall

be conducted, insofar as is practical, in

accordance with the agenda published

in this Federal Register notice. Changes

in the agenda will be announced at the

beginning of the open portion of a

meeting.

Any interested person who wishes to

be assured of the right to make an oral

presentation at the open public hearing

portion of a meeting shall inform the

contact person listed above, either orally

or in writing, prior to the meeting. Any

person attending the hearing who does

not in advance of the meeting request an

opportunity to speak will be allowed to

make an oral presentation at the

hearing’s conclusion, if time permits, at

the chairperson’s discretion.

The agenda, the questions to be

addressed by the committee, and a

current list of committee members will

be available at the meeting location on

the day of the meeting.

Transcripts of the open portion of the

meeting may be requested in writing

from the Freedom of Information Office

(HFI–35), Food and Drug

Administration, 5600 Fishers Lane, rm.

12A–16, Rockville, MD 20857,

approximately 15 working days after the

meeting, at a cost of 10 cents per page.

The transcript may be viewed at the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857, approximately 15

working days after the meeting, between

the hours of 9 a.m. and 4 p.m., Monday

through Friday. Summary minutes of

the open portion of the meeting may be

requested in writing from the Freedom

of Information Office (address above)

beginning approximately 90 days after

the meeting.

The Commissioner has determined for

the reasons stated that those portions of

the advisory committee meetings so

designated in this notice shall be closed.

The Federal Advisory Committee Act

(FACA) (5 U.S.C. app. 2, 10(d)), permits

such closed advisory committee

meetings in certain circumstances.

Those portions of a meeting designated

as closed, however, shall be closed for

the shortest possible time, consistent

with the intent of the cited statutes.

The FACA, as amended, provides that

a portion of a meeting may be closed

where the matter for discussion involves

a trade secret; commercial or financial

information that is privileged or

confidential; information of a personal

nature, disclosure of which would be a

clearly unwarranted invasion of

personal privacy; investigatory files

compiled for law enforcement purposes;

information the premature disclosure of

which would be likely to significantly

frustrate implementation of a proposed

agency action; and information in

certain other instances not generally

relevant to FDA matters.

Examples of portions of FDA advisory

committee meetings that ordinarily may

be closed, where necessary and in

accordance with FACA criteria, include

the review, discussion, and evaluation

of drafts of regulations or guidelines or

similar preexisting internal agency

documents, but only if their premature

disclosure is likely to significantly

frustrate implementation of proposed

agency action; review of trade secrets

and confidential commercial or

financial information submitted to the

agency; consideration of matters

involving investigatory files compiled

for law enforcement purposes; and

review of matters, such as personnel

records or individual patient records,

where disclosure would constitute a

clearly unwarranted invasion of

personal privacy.

Examples of portions of FDA advisory

committee meetings that ordinarily shall

not be closed include the review,

discussion, and evaluation of general

preclinical and clinical test protocols

and procedures for a class of drugs or

devices; consideration of labeling

requirements for a class of marketed

drugs or devices; review of data and

information on specific investigational

or marketed drugs and devices that have

previously been made public;

presentation of any other data or

information that is not exempt from

public disclosure pursuant to the FACA,

as amended; and, deliberation to

formulate advice and recommendations

to the agency on matters that do not

independently justify closing.

This notice is issued under section

10(a)(1) and (a)(2) of the Federal

Advisory Committee Act (5 U.S.C. app.

2), and FDA’s regulations (21 CFR part

14) on advisory committees.

Dated: January 22, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–2239 Filed 1–28–97; 8:45 am]

BILLING CODE 4160–01–F

Health Care Financing Administration

[Form # HCFA–1500]

Emergency Clearance: Public

Information Collection Requirements

Submitted to the Office of Management

and Budget (OMB)

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 (DHHS), has submitted

to the Office of Management and Budget

(OMB) the following request for

Emergency review. We are requesting an

emergency review because the

collection of this information is needed

prior to the expiration of the normal

time limits under OMB’s regulations at

5 CFR, Part 1320, in order to prevent

providers from denying services to

beneficiaries. The Agency cannot

reasonably comply with the normal

clearance procedures because public

harm is likely to result if normal

clearance procedures are followed.

Without this information, HCFA would

not be able to process claims possibly

resulting in the denial of services to
Federal Register / Vol. 62, No. 19 / Wednesday, January 29, 1997 / Notices 4305

Medicare Beneficiaries, due to provider

non-payment.

HCFA is requesting that OMB provide

a seven working day review and a 180-

day approval. During this 180-day

period HCFA will pursue OMB

clearance of this collection as stipulated

by 5 CFR 1320.5.

1. Type of Information Collection

Request: Reinstatement without change,

of a previously approved collection;

Title of Information Collection:

Medicare/Medicaid Health Insurance

Common Claim Form and Instructions,

and Supporting Regulations 42 CFR

424.32 (Basic Requirements for all

Claims) and 42 CFR 414.40 (Coding and

Ancillary Policies); Form No.: HCFA–

1500; Use: This form and instructions

are standardized for use in the

Medicare/Medicaid programs to apply

for reimbursement for covered services.

HCFA does not require exclusive use of

this form for Medicaid. 42 CFR 424.32

and 42 CFR 414.40 are regulations

underlying the use of the form HCFA–

1500 and the information captured on

the form HCFA–1500, including the use

of diagnostic and procedural coding

systems; Frequency: On occasion;

Affected Public: Business or other for

profit, not for profit institutions, State,

local or tribal government; Number of

Respondents: 976,239; Total Annual

Responses: 614,967,982; Total Annual

Hours: 52,139,385.

To request copies of the proposed

paperwork collections referenced above,

call the Reports Clearance Office on

(410) 786–1325. Written comments and

recommendations for the proposed

information collections should be sent

within five working days of this notice

directly to the OMB Desk Officer

designated at the following address:

OMB Human Resources and Housing

Branch, Attention: Allison Eydt, New

Executive Office Building, Room 10235,

Washington, DC. 20503.

Dated: January 23, 1997.

Edwin J. Glatzel,

Director, Management Analysis and Planning

Staff, Office of Financial and Human

Resources, Health Care Financing

Administration.

[FR Doc. 97–2088 Filed 1–28–97; 8:45 am]

BILLING CODE 4120–03–P

[ORD–089–N]

Medicare and Medicaid Programs;

Small Business Innovation Research

Grants for Fiscal Year 1997

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice.

SUMMARY: This notice announces the

availability of HCFA funding, through

grants, for small businesses under the

Small Business Innovation Research

(SBIR) Program. This notice contains

information about the subject areas for

grants that will be given priority,

application requirements, review

procedures, and other relevant

information.

DATES: Grant applications must be

submitted by April 29, 1997, in order to

be considered under the fiscal year (FY)

1997 annual funding cycle.

ADDRESSES: Standard application forms

and related instructions are available

from and must be formally submitted to:

HCFA Grants Officer, Office of

Acquisition and Grants, Health Care

Financing Administration, 7500

Security Boulevard, C2–21–15,

Baltimore, MD 21244–1856, (410) 786–

5701.

FOR FURTHER INFORMATION CONTACT: Carl

Hackerman, (410) 786–6644. Internet:

Chackerman@hcfa.gov.

SUPPLEMENTARY INFORMATION:

I. Small Business Innovation Research

Program

The Small Business Innovation

Development Act of 1982 (Public Law

97–219, enacted on July 22, 1982), as

amended by the Small Business

Innovation Research Program Extension

(Public Law 99–443, enacted on October

6, 1986), the Small Business

Administration Reauthorization and

Amendment Act of 1988 (Public Law

100–590, enacted on November 3, 1988),

the Small Business Research and

Development Enhancement Act of 1992

(Public Law 102–564, enacted on

October 28, 1992), and the Small

Business Administration

Reauthorization Act of 1994 (Public Law

104–403, enacted on October 2, 1994),

(15 U.S.C. 638(e) through (m)), requires

Federal agencies to reserve a specific

amount of their extramural research and

budgets for a Small Business Innovation

Research (SBIR) Program. This SBIR

Program is intended to—

• Stimulate technological

innovation;

• Use small business to meet Federal

research and demonstrations (‘‘R & D’’)

needs;

• Increase private sector

commercialization of innovations

derived from Federal R & D; and

• Foster and encourage participation

by minority and disadvantaged persons

in technological innovation.

The principal purpose of HCFA’s

SBIR Program is to provide assistance to

creative applicants so that innovation

can be encouraged that will result in

better health care.

A. SBIR Program Phases, Award

Amounts, and Period of Support

The SBIR Program consists of the

following three phases:

Phase I

The objective of this phase is to

establish the technical merit and

feasibility of proposed research or

Research and Demonstrations efforts

and to determine the quality of

performance of the small business

awardee organization before furnishing

further Federal support in Phase II.

Phase I awards will be approximately

$50,000 (for both direct and indirect

costs) for a period not to exceed 12

months.

Phase II

The objective of this phase is to

continue the research or R & D efforts

initiated in Phase I and to actually

create the proposed product and test it

before marketing. Funding is based on

the results of Phase I and technical

merit of the Phase II application,

including its potential for

commercialization. (Only Phase I

awardees are eligible to apply for Phase

II funding.) Phase I awardees are eligible

to apply for Phase II funding only from

the Federal agency that supported their

Phase I project. Phase II awards will be

approximately $100,000 to 150,000 (for

both direct and indirect costs) for a

period normally not to exceed 12

months.

Phase III

The objective of this phase, if

appropriate, is for the small business

concern to pursue with non-Federal

funds the commercialization of the

results of the research or R & D in

Phases I and II.

The purpose of this notice is to invite

Phase I and II grant applications from

for-profit domestic small business

concerns that have the expertise to

develop or further develop innovative

technology. This technology should be

compatible with the general mission of

HCFA and contribute to the health care

field. HCFA is responsible for the

Medicare program, Federal participation

in the Medicaid program, and related

health care quality assurance programs.

HCFA’s mission is to promote the

timely delivery of appropriate quality

health care to its Medicare beneficiaries

and Medicaid recipients—over 70

million of the nation’s aged, disabled,

and poor. HCFA must also ensure that

Medicare beneficiaries and Medicaid

recipients are aware of the services for