Federal Register / Vol. 62, No. 40 / Friday, February 28, 1997 / Notices 9201

Closed presentation of data. On

March 20, 1997, the sponsor may

present to the committee trade secret

and/or confidential commercial

information regarding the premarket

notification submission. 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: February 25, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–5129 Filed 2–26–97; 11:04 am]

BILLING CODE 4160–01–F

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:

Application for Certification as a

Federally Qualified Health Center

(FQHC) (OMB No. 0915–0142);

Extension and Revision

The Federally Qualified Health Center

(FQHC) Look-Alike application package

(OMB No. 0915–0142) was developed to

certify entities as FQHC providers under

Medicaid and Medicare. FQHCs receive
9202 Federal Register / Vol. 62, No. 40 / Friday, February 28, 1997 / Notices

reasonable cost-related reimbursement

under Medicaid and Medicare for a full

range of primary health care services.

The application for FQHC certification

is divided into four components: (1)

Need and Community Impact, (2) Health

Services, (3) Management and Finance,

and (4) Governance. Certified FQHC

Look-Alikes must submit an annual

recertification document with updated

exhibits to retain designation as an

FQHC.

In an effort to improve the procedures

for certifying FQHCs, HRSA is

considering revising the FQHC LookAlike application (with parallel changes

made to the recertification

requirements). The revised version

would update the application guidelines

and exhibits to reflect current law,

regulations, and practice. A revised

application may also include more

specific guidance on how applicants

should document existing unmet need

in the community.

These revisions will be developed

during the next year and submitted for

OMB approval in 1998. In the interim,

a request for a two-year extension of

OMB approval of the current forms is

being submitted. Only minor technical

changes have been made to the forms.

Estimates of annualized hour burden are

as follows:

Form name Number of

respondents

Responses

per respondent

Hours per

response

Total burden hours

Application ........................................................................................................................ 70 1 120 8,400

Recertification ................................................................................................................... 231 1 20 4,620

Total ........................................................................................................................... 301 1 43 13,020

Written comments and

recommendations concerning the

proposed information collection should

be sent within 30 days of this notice to:

Virginia Huth, Human Resources and

Housing Branch, Office of Management

and Budget, New Executive Office

Building, Room 10235, Washington, DC

20503.

Dated: February 10, 1997.

J. Henry Montes,

Director, Office of Policy and Information

Coordination.

[FR Doc. 97–4957 Filed 2–27–97; 8:45 am]

BILLING CODE 4160–15–P

Substance Abuse and Mental Health

Services Administration

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

Periodically, the Substance Abuse and

Mental Health Services Administration

(SAMHSA) will publish a list of

information collection requests under

OMB review, in compliance with the

Paperwork Reduction Act (44 U.S.C.

Chapter 35). To request a copy of these

documents, call the SAMHSA Reports

Clearance Officer on (301) 443–0525.

Alcohol and Drug Services Study

(ADSS) Phase II/III—New—Phases II

and III of the ADSS will continue the

collection of linked information on

substance abuse treatment begun in the

Phase I facility level survey. Phase II

involves on-site interviews with

administrators at 270 treatment facilities

and a a record abstraction of client-level

data on 8,800 treatment clients. Phase III

consists of client followup interviews to

determine post-discharge substance

abuse, criminal activity, employment,

and other social functioning. ADSS will

provide researchers, policy makers, and

providers with detailed national data on

the current substance abuse treatment

delivery system and clients in the

system. The annualized burden is

shown below.

No. of respondents

No. of responses/respondent

Avg. burden/response Total study burden Annualized burden

Treatment Facilities ................................................... 270 1.33 1.755 hours ............ 630 hours ............... 126 hours

Clients ....................................................................... 8,800 3.38 1.125 hours ............ 29,700 hours .......... 5,940 hours.

Drug Abuse Warning Network (DAWN)—Extension of a currently approved collection—The Drug Abuse Warning

Network (DAWN) collects data on drug-related medical emergencies and deaths as reported from about 650 hospitals

and medical examiners nationwide. Used by Federal, State and local agencies, this on-going data system supports efforts

to identify drug abuse trends; assesses health hazards associated with substance abuse; and schedules substances under

the Controlled Substances Act. The annual burden estimate is 15,972 hours as shown below:

No.of respondents

No.of responses per

respondent

Average burden per

response

Gross burden hoursIR 1 reporting hours

Total adjusted burden hours

Hospitals ............................................................... 500 368 0.133 hrs. ............... 24,480 10,282 14,198

Medical Examiners ............................................... 150 123 0.160 hrs. ............... 2,957 1,183 1,774

1There is no burden associated with reporting by Independent Reporters (IRs), therefore these hours are not included in the Total Adjusted

Burden Hours.

Written comments and

recommendations concerning the

proposed information collections

should be sent within 30 days of this

notice to: Virginia Huth, Human

Resources and Housing Branch, Office

of Management and Budget, New

Executive Office Building, Room 10236,

Washington, D.C. 20503.