55646 Federal Register / Vol. 62, No. 207 / Monday, October 27, 1997 / Notices

Fishers Lane, Rockville, MD 20857,

301–827–2250.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of a

guidance for industry entitled ‘‘OTC

Treatment of Hypercholesterolemia.’’

Several sponsors have recently

expressed interest in marketing

cholesterol-lowering agents as OTC drug

products. These requests have raised

several regulatory policy and medical

therapy issues.

This guidance document represents

the agency’s current thinking on OTC

treatment of hypercholesterolemia. 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 an approach satisfies the

requirement of the applicable statute,

regulations, or both.

Interested persons may, at any time,

submit written comments on the

guidance to the Dockets Management

Branch (address above). Two copies of

any comments are to be submitted,

except that 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 and received

comments are available for public

examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday. Persons

with access to the Internet may obtain

the guidance by using the World Wide

Web (WWW). For WWW access, go to

‘‘http://www.fda.gov/cder/guidance/

index.htm’’.

Dated: October 17, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–28298 Filed 10–24–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Proposed Collection; Comment

Request; Treatment Observation’s

Study

SUMMARY: In compliance with Section

3506(c)(2)(A) of the Paperwork

Reduction Act of 1995, for opportunity

for public comment on proposed data

collection projects, the National

Institute on Alcohol Abuse and

Alcoholism (NIAAA), National

Institutes of Health (NIH) will publish

periodic summaries of proposed

projects to be submitted to the Office of

Management and Budget (OMB) for

review and approval.

PROPOSED COLLECTION: The Treatment

Research Branch (TRB), intends to

conduct the study for ‘‘Treatment

Observation’’. The TRB is authorized by

Section 452 of Part G of Title IV of the

Public Health Service Act (42 U.S.C.

288) as amended by the NIH

Revitalization Act of 1993 (Pub. L. 103–

43).

The information proposed for

collection will be used by the NIAAA to

observe group treatment at up to 20

treatment facilities. At each facility,

directors will be asked to provide

information about treatment practices

and about the client population. At each

facility at least seven members of the

treatment staff will be asked to provide

information about their treatment

activities, personal experiences and

training. At each facility eight treatment

groups will be observed. The group

leader will be asked to complete a

questionnaire about the observed

session and other client demographics.

At least seven group members will also

be asked to complete a questionnaire

about the observed group session. The

target population for the study is a

group of outpatient public and private

providers that will include group

treatment as part of their overall plan of

clinical therapeutics.

The specific aim of this study is the

testing of instruments and

methodologies for the systematic

measurement of the content, process,

and context of group treatment.

The annual burden estimates are as

follows:

Type and number of respondents

Responses

per

respondent

Total

responses Hours Total hours

Facility Director—20 ....................................................................................... 1 20 .75 15

Group Leader—160 ........................................................................................ 1 160 .334 55

Treatment Staff—140 ..................................................................................... 1 140 .334 48

Group Member—1120 .................................................................................... 1 1120 .334 381

Total Number of Respondents ................................................................ ........................ 1440

Total Number of Responses ................................................................... ........................ 1440 .......................... ........................

Total Hours .............................................................................................. ........................ 499 .......................... ........................

REQUEST FOR COMMENTS: Comments are

invited on: (a) Whether the proposed

collection is necessary, including

whether the information has practical

use; (b) ways to enhance the clarity,

quality, and use of the information to be

collected; (c) the accuracy of the agency

estimate of burden of the proposed

collection; and (d) ways to minimize the

collection burden of the respondents.

Send written comments to Dr. Margaret

Mattson, Treatment Research Branch,

Division of Clinical and Prevention

Research (DCPR), NIAAA. NIH, Willco

Building 6000, Room 505, 6000

Executive Boulevard, Bethesda,

Maryland 20892–7003.

FOR FURTHER INFORMATION CONTACT:

To request more information on the

proposed project or to obtain a copy of

the data collection plans, contact Dr.

Margaret Mattson, Treatment Research

Branch, Division of Clinical and

Prevention Research (DCPR), NIAAA,

NIH, 6000 Willco Building, Room 505,

6000 Executive Boulevard, Bethesda,

Maryland 20892–7003, or call non-tollfree number (301) 443–0638.

COMMENTS DUE DATE: Comments

regarding this information collection are

best assured of having their full effect if

received within 60-days of the date of

this publication.

Dated: October 20, 1997.

Martin K. Trusty,

Executive Officer, NIAAA.

[FR Doc. 97–28382 Filed 10–24–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Center for Scientific Review; Notice of

Closed Meetings

Pursuant to Section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice
Federal Register / Vol. 62, No. 207 / Monday, October 27, 1997 / Notices 55647

is hereby given of the following Center

for Scientific Review Special Emphasis

Panel (SEP) meetings:

Purpose/Agenda: To review individual

grant applications.

Name of SEP: Multidisciplinary Sciences.

Date: November 3–4, 1997.

Time: 8:00 a.m.

Place: University Center Hotel, Gainesville,

Florida.

Contact Person: Dr. Houston Baker,

Scientific Review Administrator, 6701

Rockledge Drive, Room 5208, Bethesda,

Maryland 20892, (301) 435–1175.

Name of SEP: Biological and Physiological

Sciences.

Date: November 7, 1997.

Time: 1:00 p.m.

Place: NIH, Rockledge 2, Room 4202,

Telephone Conference.

Contact Person: Dr. Calbert Laing,

Scientific Review Administrator, 6701

Rockledge Drive, Room 4202, Bethesda,

Maryland 20892, (301) 435–1221.

This notice is being published less than 15

days prior to the above meetings due to the

urgent need to meet timing limitations

imposed by the grant review and funding

cycle.

Name of SEP: Clinical Sciences.

Date: November 13, 1997.

Time: 10:00 a.m.

Place: Embassy Suites, Chevy Chase, MD.

Contact Person: Dr. Jerrold Fried, Scientific

Review Administrator, 6701 Rockledge Drive,

Room 4126, Bethesda, Maryland 20892, (301)

435–1777.

Name of SEP: Microbiological and

Immunological Sciences.

Date: November 13, 1997.

Time: 2:00 p.m.

Place: NIH, Rockledge 2, Room 5110,

Telephone Conference.

Contact Person: Dr. Mohindar Poonian,

Scientific Review Administrator, 6701

Rockledge Drive, Room 5110, Bethesda,

Maryland 20892, (301) 435–1168.

Name of SEP: Biological and Physiological

Sciences.

Date: November 17, 1997.

Time: 1:30 p.m.

Place: NIH, Rockledge 2, Room 5196,

Telephone Conference.

Contact Person: Ms. Carol Campbell,

Scientific Review Administrator, 6701

Rockledge Drive, Room 5196, Bethesda,

Maryland 20892, (301) 435–1257.

Name of SEP: Biological and Physiological

Sciences.

Date: November 24, 1997.

Time: 11:30 a.m.

Place: NIH, Rockledge 2, Room 5196,

Telephone Conference.

Contact Person: Ms. Carol Campbell,

Scientific Review Administrator, 6701

Rockledge Drive, Room 5196, Bethesda,

Maryland 20892, (301) 435–1257.

Name of SEP: Clinical Sciences.

Date: November 26, 1997.

Time: 1:00 p.m.

Place: NIH, Rockledge 2, Room 4126,

Telephone Conference.

Contact Person: Dr. Jerrold Fried, Scientific

Review Administrator, 6701 Rockledge Drive,

Room 4126, Bethesda, Maryland 20892, (301)

435–1777.

Name of SEP: Chemistry and Related

Sciences.

Date: December 2–4, 1997.

Time: 5:00 p.m.

Place: Holiday Inn-University Center,

Philadelphia, PA.

Contact Person: Dr. Nancy Lamontagne,

Scientific Review Administrator, 6701

Rockledge Drive, Room 4170, Bethesda,

Maryland 20892, (301) 435–1726.

Name of SEP: Chemistry and Related

Sciences.

Date: December 3, 1997.

Time: 8:30 a.m.

Place: NIH, Rockledge 2, Room 4168,

Telephone Conference.

Contact Person: Dr. John Bowers, Scientific

Review Administrator, 6701 Rockledge Drive,

Room 4168, Bethesda, Maryland 20892, (301)

435–1725.

The meetings will be closed in accordance

with the provisions set forth in secs.

552b(c)(4) and 552b(c)(6), Title 5, U.S.C.

Applications and/or proposals and the

discussions could reveal confidential trade

secrets or commercial property such as

patentable material and personal information

concerning individuals associated with the

applications and/or proposals, the disclosure

of which would constitute a clearly

unwarranted invasion of personal privacy.

(Catalog of Federal Domestic Assistance

Program Nos. 93.306, 93.333, 93.337, 93.393–

93.396, 93.837–93.844, 93.846–93.878,

93.892, 93.893, National Institutes of Health,

HHS)

Dated: October 20, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–28379 Filed 10–24–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Child Health and

Human Development; Notice of

Meeting

Pursuant to Section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following

National Institute of Child Health and

Human Development Special Emphasis

Panel (SEP) meeting:

The meeting will be open to the

public to provide concept review of

proposed contract solicitations.

Individuals who plan to attend and

need special assistance, such as sign

language interpretation or other

reasonable accommodations, should

inform the Contact Person listed below

in advance of the meeting.

Name of Panel: The Effects of Swimming

Lessons on the Risk of Drowning

(TELECONFERENCE).

Date: November 5, 1997.

Time: 2:00 p.m. (ET)—adjournment.

Place: 6100 Executive Boulevard, 6100

Building—Room 5E01, Rockville, Maryland

20852.

Contact Person: Hameed Khan, Ph.D.,

Scientific Review Administrator, NICHD,

6100 Executive Boulevard, 6100 Building—

Room 5E01, Rockville, Maryland 20852,

Telephone: 301–496–1696.

Purpose/Agenda: To provide concept

review of proposed contract solicitations.

This notice is published less than 15 days

prior to the meeting due to the urgent need

to meet timing limitations imposed by the

review and funding cycle.

(Catalog of Federal Domestic Assistance

Program Nos. [93.864, Population Research

and No. 93.865, Research Mothers and

Children], National Institutes of Health)

Dated: October 21, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–28378 Filed 10–24–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Diabetes and

Digestive and Kidney Diseases; Notice

of Closed Meeting

Pursuant to Section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following

National Institute of Diabetes and

Digestive and Kidney Diseases Special

Emphasis Panel meeting:

Name of SEP: ZDK1–GRB–7 (J1).

Date: November 17–19, 1997.

Time: 7:30 p.m.

Place: The Quarterage Hotel, 560 Westport

Road, Kansas City, MO 64111.

Contact Person: Lakshmanan Sankaran,

Ph.D., Scientific Review Administrator,

Review Branch, DEA, NIDDK, Natcher

Building, Room 6as–25F, National Institutes

of Health, Bethesda, Maryland 20892–6600,

Phone: (301) 594–7799.

Purpose/Agenda: To review and evaluate

grant applications.

This meeting will be closed in accordance

with the provisions set forth in secs.

552b(c)(4) and 552b(c)(6), Title 5 U.S.C.

Applications and/or proposals and the

discussions could reveal confidential trade

secrets or commercial property such as

patentable material and personal information

concerning individuals associated with the

applications and/or proposals, the disclosure

of which would constitute a clearly

unwarranted invitation of person privacy.

(Catalog of Federal Domestic Assistance

Program No. 93.847–849, Diabetes, Endocrine

and Metabolic Diseases; Digestive Diseases