Federal Register / Vol. 62, No. 32 / Tuesday, February 18, 1997 / Notices 7237

Executive Order 12372 Review

Applications are not subject to the

review requirements of Executive Order

12372, entitled Intergovernmental

Review of Federal Programs.

Public Health System Reporting

Requirement

This program is not subject to the

Public Health System Reporting

Requirements.

Catalog of Federal Domestic Assistance

Number

The Catalog of Federal Domestic

Assistance number is 93.262.

Other Requirements

Human Subjects

The applicant must comply with the

Department of Health and Human

Services Regulations, 45 CFR part 46,

regarding the protection of human

subjects. Assurances must be provided

to demonstrate that the project will be

subject to initial and continuing review

by an appropriate institutional review

committee. The applicant will be

responsible for providing assurance in

accordance with the appropriate

guidelines and form provided in the

application kit.

Women and Racial and Ethnic

Minorities

It is the policy of the CDC to ensure

that women and racial and ethnic

groups will be included in CDC

supported research projects involving

human subjects, whenever feasible and

appropriate. Racial and ethnic groups

are those defined in OMB Directive No.

15 and include American Indian,

Alaskan Native, Asian, Pacific Islander,

Black and Hispanic. Applicants shall

ensure that women and racial and

ethnic minority populations are

appropriately represented in

applications for research involving

human subjects. Where clear and

compelling rationale exist that inclusion

is not feasible, this situation must be

explained as part of the application. In

conducting the review of applications

for scientific merit, review groups will

evaluate proposed plans for inclusion of

minorities and both sexes as part of the

scientific assessment and assigned

score. This policy does not apply to

research studies when the investigator

cannot control the race, ethnicity and/

or sex of subjects. Further guidance to

this policy is contained in the Federal

Register, Vol. 60, No. 179, Friday,

September 15, 1995, pages 47947–

47951.

Application Submission and Deadlines

A. Preapplication Letter of Intent

Although not a prerequisite of

application, a non-binding letter of

intent-to-apply is requested from

potential applicants. The letter should

be submitted to the Grants Management

Officer (whose address is reflected in

section B, ‘‘Applications’’). It should be

postmarked no later than March 14,

1997. The letter should identify the

announcement number, name of

principal investigator, and specify the

priority area to be addressed by the

proposed project. The letter of intent

does not influence review or funding

decisions, but it will enable CDC to plan

the review more efficiently, and will

ensure that each applicant receives

timely and relevant information prior to

application submission.

B. Applications

Applicants should use Form PHS–398

(OMB Number 0925–0001) and adhere

to the ERRATA Instruction Sheet for

Form PHS–398 contained in the grant

application kit. Please submit an

original and five copies on or before

May 14, 1997 to: Ron Van Duyne, Grants

Management Officer, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention, (CDC), 255 East

Paces Ferry Road, NE., Room 321, MSE13, Atlanta, GA 30305.

C. Deadlines

1. Applications shall be considered as

meeting a deadline if they are either:

A. Received at the above address on

or before the deadline date, or

B. Sent on or before the deadline date

to the above address, and received in

time for the review process. Applicants

should request a legibly dated U.S.

Postal Service postmark or obtain a

legibly dated receipt from a commercial

carrier or the U.S. Postal Service. Private

metered postmarks shall not be accepted

as proof of timely mailings.

2. Applications which do not meet the

criteria above are considered late

applications and will be returned to the

applicant.

Where To Obtain Additional

Information

To receive additional written

information call (404) 332–4561. You

will be asked your name, address, and

telephone number and will need to refer

to Announcement 722. You will receive

a complete program description,

information on application procedures,

and application forms. In addition, this

announcement is also available through

the CDC Home Page on the Internet. The

address for the CDC Home Page is http:/

/www.cdc.gov. If you have questions

after reviewing the contents of all the

documents, business management

technical assistance may be obtained

from Georgia Jang, Grants Management

Specialist, Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention

(CDC), 255 East Paces Ferry Road, NE.,

MS–E13, Atlanta, GA 30305, telephone

(404) 842–6796; fax: 404–842–6513;

internet: glj2@cdc.gov. Programmatic

technical assistance may be obtained

from Roy M. Fleming, Sc.D., Associate

Director for Grants, National Institute

for Occupational Safety and Health,

Centers for Disease Control and

Prevention (CDC), 1600 Clifton Road,

NE., Building 1, Room 3053, MS–D30,

Atlanta, GA 30333, telephone 404–639–

3343; fax: 404–639–4616; internet:

rmf2@cdc.gov.

Please Refer to Announcement Number

722 When Requesting Information and

Submitting an Application.

Potential applicants may obtain a

copy of ‘‘Healthy People 2000’’ (Full

Report, Stock No. 017–001–00474–0) or

‘‘Healthy People 2000’’ (Summary

Report, Stock No. 017–001–00473–1)

through the Superintendent of

Documents, Government Printing

Office, Washington, DC 20402–9325,

telephone (202) 512–1800.

Dated: February 11, 1997.

Diane D. Porter,

Acting Director, National Institute for

Occupational Safety and Health, Centers for

Disease Control and Prevention (CDC).

[FR Doc. 97–3909 Filed 2–14–97; 8:45 am]

BILLING CODE 4163–19–P

Food and Drug Administration

Advisory Committees; Tentative

Schedule of Meetings for 1997

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing a

tentative schedule of forthcoming

meetings of its public advisory

committees for 1997. At the request of

the Commissioner of Food and Drugs

(the Commissioner), the Institute of

Medicine (the IOM) conducted a study

of the use of FDA’s advisory

committees. The IOM recommended

that the agency publish an annual

tentative schedule of its meetings in the

Federal Register. In response to that

recommendation, FDA is publishing its
7238 Federal Register / Vol. 62, No. 32 / Tuesday, February 18, 1997 / Notices

annual tentative schedule of meetings

for 1997.

FOR FURTHER INFORMATION CONTACT:

Donna M. Combs, Committee

Management Office (HFA–306), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–827–

4820.

SUPPLEMENTARY INFORMATION: The IOM,

at the request of the Commissioner,

undertook a study of the use of FDA’s

advisory committees. In its final report,

the IOM recommended that FDA adopt

a policy of publishing an advance yearly

schedule of its upcoming public

advisory committee meetings in the

Federal Register. FDA has implemented

this recommendation. A tentative

schedule of forthcoming meetings will

be published annually in the Federal

Register. The annual publication of

tentatively scheduled advisory

committee meetings will provide both

advisory committee members and the

public with the opportunity, in advance,

to schedule attendance at FDA’s

upcoming advisory committee meetings.

The schedule is tentative and

amendments to this notice will not be

published in the Federal Register. FDA

will, however, publish a Federal

Register notice at least 15 days in

advance of each upcoming advisory

committee meeting, announcing the

meeting (21 CFR 14.20).

The following list announces FDA’s

tentatively scheduled advisory

committee meetings for 1997:

Committee name Dates of meetings Hotline code

OFFICE OF THE COMMISSIONER

Science Board to the Food and Drug Administration March 13 ...................................................................... 12603

May 14

November 5

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

Allergenic Products Advisory Committee April 17–18 ................................................................... 12388

September 29–30

Biological Response Modifiers Advisory Committee January 30 ................................................................... 12388

May 6–7

July 24–25

October 16–17

Blood Products Advisory Committee March 13–14 ................................................................ 12388

June 19–20

September 18–19

December 11–12

Transmissible Spongiform Encephalopathies Advisory Committee To be announced (presently, committee is unstaffed) 12388

Vaccines and Related Biological Products Advisory Committee January 30 ................................................................... 12388

March 14

April 10–11

July 10–11

October 27–28

CENTER FOR DRUG EVALUATION AND RESEARCH

Advisory Committee for Pharmaceutical Science May 7–8 ....................................................................... 12539

August 20–21

Advisory Committee for Reproductive Health Drugs June 5–6 ...................................................................... 12537

Anesthetic and Life Support Drugs Advisory Committee March 27–28 ................................................................ 12529

May 22–23

September 17–18

Anti-Infective Drugs Advisory Committee January 22 (joint meeting with Nonprescription Drugs

Advisory Committee)

12530

March 5–7

July 24–25

November 20–21

Antiviral Drugs Advisory Committee February 21 .................................................................. 12531

April 24–25

September 11–12

Arthritis Advisory Committee February 4–5 ................................................................ 12532

March 18–19

May 6–7

July 22–23

November 4–5

Cardiovascular and Renal Drugs Advisory Committee January 23 (joint meeting with Nonprescription Drugs

Advisory Committee)

12533

February 27–28

June 26–27

October 23–24

Dermatologic and Ophthalmic Drugs Advisory Committee April 17–18 ................................................................... 12534

July 17–18

September 15–16

November 13–14

Drug Abuse Advisory Committee February 10–11 ............................................................ 12535

June 9–10

November 20–21

Endocrinologic and Metabolic Drugs Advisory Committee February 20–21 ............................................................ 12536
Federal Register / Vol. 62, No. 32 / Tuesday, February 18, 1997 / Notices 7239

Committee name Dates of meetings Hotline code

March 25–26

April 14–15

May 13–14

July 10–11

August 21–22

September 22–23

November 20–21

Gastrointestinal Drugs Advisory Committee September 18–19 ........................................................ 12538

December 2

Medical Imaging Drugs Advisory Committee March 6–7 .................................................................... 12540

Nonprescription Drugs Advisory Committee January 22 (joint meeting with Anti-Infective Drugs

Advisory Committee)

12541

January 23 (joint meeting with Cardiovascular and

Renal Drugs Advisory Committee)

March 17–19

May 13–14 (with representation from Endocrinologic

and Metabolic Drugs Advisory Committee)

Oncologic Drugs Advisory Committee March 7 ........................................................................ 12542

May 1–2

June 23–24

Peripheral and Central Nervous System Drugs Advisory Committee June 26–27 .................................................................. 12543

Psychopharmacologic Drugs Advisory Committee July 14–16 .................................................................... 12544

August 4–5

November 5–7

Pulmonary-Allergy Drugs Advisory Committee April 10–11 ................................................................... 12545

CENTER FOR FOOD SAFETY AND APPLIED NUTRITION

Food Advisory Committee March 20–21 ................................................................ 10564

May 21–23

July 30–31 and

August 1

September 24–26

November 19–21

CENTER FOR DEVICES AND RADIOLOGICAL HEALTH

Device Good Manufacturing Practice Advisory Committee No meetings planned ................................................... 12398

Medical Devices Advisory Committee ......................................................................................

Anesthesiology and Respiratory Therapy Devices Panel June 6 .......................................................................... 12624

September 5

November 21

Circulatory System Devices Panel June 16 ........................................................................ 12625

November 17

Clinical Chemistry and Clinical Toxicology Devices Panel March 20-21 ................................................................. 12514

May 8

July 24–25

September 25–26

Dental Products Panel February 12 .................................................................. 12518

May 21–23

July 14–16

November 3–5

Ear, Nose, and Throat Devices Panel May 20–21 ................................................................... 12522

October 22–23

December 11–12

Gastroenterology-Urology Devices Panel January 16 ................................................................... 12523

May 1–2

August 7–8

November 6–7

General and Plastic Surgery Devices Panel May 5–6 ....................................................................... 12519

August 4–5

November 3–4

General Hospital and Personal Use Devices Panel June 2–3 ...................................................................... 12520

September 15–16

November 13–14

Hematology and Pathology Devices Panel June 26–27 .................................................................. 12515

September 4–5

November 20–21

Immunology Devices Panel June 13 ........................................................................ 12516

September 19

December 5

Microbiology Devices Panel June 19–20 .................................................................. 12517

September 11–12

Neurological Devices Panel March 14 ...................................................................... 12513

June 27

Obstetrics-Gynecology Devices Panel April 14–15 ................................................................... 12524
7240 Federal Register / Vol. 62, No. 32 / Tuesday, February 18, 1997 / Notices

Committee name Dates of meetings Hotline code

July 14–15

October 6–7

Ophthalmic Devices Panel January 13–14 ............................................................. 12396

March 27–28

July 10–11

October 20–21

Orthopedic and Rehabilitation Devices Panel March 6–7 .................................................................... 12521

June 9–10

October 15–16

Radiological Devices Panel February 24 .................................................................. 12526

May 12

August 18

November 17

National Mammography Quality Assurance Advisory Committee January 13–15 ............................................................. 12397

August 18–20

November 3–5

Technical Electronic Product Radiation Safety Standards CommitteeApril 8–9 ....................................................................... 12399

CENTER FOR VETERINARY MEDICINE

Veterinary Medicine Advisory Committee May 13–14 ................................................................... 12546

NATIONAL CENTER FOR TOXICOLOGICAL RESEARCH

Advisory Committee on Special Studies Relating to the Possible

Long-Term Health Effects of Phenoxy Herbicides and Contaminants (Ranch Hand Advisory Committee)

September 15–16 ........................................................ 12560

Science Advisory Board to the National Center for Toxicological ResearchJune 4–5 ...................................................................... 12559

FDA has established an Advisory

Committee Information Hotline (the

hotline) using a voice-mail telephone

system. The hotline provides the public

with access to the most current

information on FDA advisory committee

meetings. The advisory committee

hotline, which will disseminate current

information and information updates,

can be accessed by dialing 1–800–741–

8138 or 301–443–0572. Each advisory

committee is assigned a 5-digit number.

This 5-digit number will appear in each

individual notice of meeting. The

hotline will enable the public to obtain

information about a particular advisory

committee by using the committee’s 5-

digit number. Information in the hotline

is preliminary and may change before a

meeting is actually held. The hotline

will be updated when such changes are

made.

Dated: February 7, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–3821 Filed 2–14–97; 8:45 am]

BILLING CODE 4160–01–F

Health Care Financing Administration

HCFA–P–15A

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

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, has submitted to the

Office of Management and Budget

(OMB) the following proposal for the

collection of information. Interested

persons are invited to send comments

regarding the burden estimate or any

other aspect of this collection of

information, including any of the

following subjects: (1) the necessity and

utility of the proposed information

collection for the proper performance of

the agency’s functions; (2) the accuracy

of the estimated burden; (3) ways to

enhance the quality, utility, and clarity

of the information to be collected; and

(4) the use of automated collection

techniques or other forms of information

technology to minimize the information

collection burden.

HCFA–P–15A Type of Information

Collection Request: Extension of

currently approved collection; Title of

Information Collection: Medicare

Current Beneficiary Survey

Supplement-Round 18; Form No.:

HCFA–′P–15A; Use: The Office of the

Actuary, HCFA, conducts the Medicare

Current Beneficiary Survey (MCBS)

through personal interviews of a

random sample of Medicare

beneficiaries. When sampled persons

are found to reside in a long-term care

facility, interviewers use a version of the

questionnaire which is specially

designed to obtain data about the

beneficiary’s health care from

knowledgeable staff members. We are

preparing to convert the facility

interview from a hard—copy

questionnaire to a Computer Assisted

Personal Interviewing (CAPI) format,

beginning in May, 1997. CAPI, which

we are currently using in the

community interviews, increases the

accuracy of the interview process by

automating skip patterns, customizing

questions, creating computed variables

such as a time line of residence history,

and automatically checking

completeness and consistency of

responses. Concurrently, we are

modifying some of the questions we

currently use in the facility interview to

make them more comparable to those in

other surveys, particularly the Medical

Expenditure Panel Survey (MEPS).

These modifications are responsive to

the President’s initiative toward

consistency and integration among

surveys; Frequency: Annually; Affected

Public:; Number of Respondents: 1,900;