Federal Register / Vol. 63, No. 132 / Friday, July 10, 1998 / Notices 37403

that office in processing your requests.

The draft guidance document may also

be obtained by mail by calling the CBER

Voice Information System at 1–800–

835–4709 or 301–827–1800, or by fax by

calling the FAX Information System at

1–888–CBER–FAX or 301–827–3844.

See the SUPPLEMENTARY

INFORMATION section for electronic

access to the draft guidance document.

Submit written comments on the draft

guidance document to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Valerie A. Butler, Center for Biologics

Evaluation and Research (HFM–17),

Food and Drug Administration, 1401

Rockville Pike, suite 200N, Rockville,

MD 20852–1448, 301–827–6210.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of

a draft guidance document entitled

‘‘Guidance for Industry: In the

Manufacture and Clinical Evaluation of

In Vitro Tests to Detect Nucleic Acid

Sequences of Human Immunodeficiency

Virus Type 1.’’ The draft guidance

document outlines some of the major

regulatory and scientific issues

concerning gene based tests for Human

Immunodeficiency Virus (HIV), these

criteria also apply to tests for other

transfusion transmitted viruses

including Human Immunodeficiency

Virus Type 2, Hepatitis C Virus,

Hepatitis B Virus, Human T–cell

Lymphotropic Virus Types I and II.

This draft guidance document

represents the agency’s current thinking

with regard to the manufacture and

clinical evaluation of in vitro testing to

detect specific nucleic acid sequences of

HIV type 1. 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

requirements of the applicable statute,

regulations, or both. As with other

guidance documents, FDA does not

intend this draft guidance document to

be all-inclusive and cautions that not all

information may be applicable to all

situations. The draft guidance document

is intended to provide information and

does not set forth requirements.

II. Comments

This draft guidance document is being

distributed for comment purposes only

and is not intended for implementation

at this time. Interested persons may

submit to the Dockets Management

Branch (address above) written

comments regarding the draft guidance

document. Written comments may be

submitted at any time; however,

comments should be submitted by

October 8, 1998, to ensure adequate

consideration in preparation of the final

guidance document. Two copies of any

comments are to be submitted, except

individuals may submit one copy.

Comments should be identified with the

docket number found in brackets in the

heading of this document. A copy of the

draft guidance document and received

comments are available for public

examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

III. Electronic Access

Persons with access to the Internet

may obtain the draft guidance document

using the World Wide Web (WWW). For

WWW access, connect to CBER at

‘‘http://www.fda.gov/cber/

guidelines.htm’’.

Dated: June 30, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–18403 Filed 7–9–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Submission for OMB Review

Collection; Comment Request;

Individual National Research Service

Award Application and Related Forms

Summary

Under the provisions of Section

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

Reduction Act of 1995, the Office of

Extramural Research, the National

Institutes of Health (NIH) has submitted

to the Office of Management and Budget

(OMB) a request to review and approve

the information collection listed below.

This proposed information collection

was previously published in the Federal

Register on April 2, 1998, pages 16268–

16269 and allowed 60-days for public

comment. No public comments were

received. The purpose of this notice is

to allow an additional 30 days for public

comment. The National Institutes of

Health may not conduct or sponsor, and

the respondent is not required to

respond to, an information collection

that has been extended, revised, or

implemented on or after October 1,

1995, unless it displays a currently valid

OMB control number.

Proposed Collection

Title: Individual National Research

Service Award Application and Related

Forms. Type of Information Collection

Request: Revision, OMB 0925–0002,

Expiration Date 9/30/98. Form

Numbers: PHS 416–1, 416–9, 416–5,

416–7, 6031, 6031–1. Need and Use of

Information Collection: The PHS 416–1

and PHS 416–9 are used by individuals

to apply for direct research training

support. Awards are made to individual

applicants for specified training

proposals in biomedical and behavioral

research, selected as a result of a

national competition. The other related

forms (PHS 416–5, 416–7, 6031 and

6031–1) are used by these individuals to

activate, terminate, and provide for

payback of a National Research Service

Award. Frequency of Response:

Applicants may submit applications for

published receipt dates. If awarded,

annual progress is reported. Related

forms are used at activation,

termination, and to provide for payback

of a National Research Service Award.

Affected Public: Individuals or

Households: Business or other for-profit;

Not-for-profit institutions; Federal

Government; and State, Local or tribal

Government. Type of Respondents:

Adult scientific trainees and

professionals. The annual reporting

burden is as follows: Estimated Number

of Respondents: 29, 748; Estimated

Number of Responses per Respondent:

1.0834; Average Burden Hours Per

Responses: 2.658 hours; and Estimated

Total Annual Burden Hours Requested:

85,679. The estimated annualized cost

to respondents is $1,985,472 (Using a

$35 physician/professor average hourly

wage rate, and a $12 trainee average

hourly wage rate.) There are no Capital

Costs to report. There are no Operating

or Maintenance costs to report.

Request for Comments

Written comments and/or suggestions

from the public and affected agencies

are invited on one or more of the

following points: (1) Whether the

proposed collection of information is

necessary for the proper performance of

the function of the agency, including

whether the information will have

practical utility; (2) The accuracy of the

agency’s estimate of the burden of the

proposed collection of information,

including the validity of the

methodology and assumptions used; (3)

Ways to enhance the quality, utility, and

clarity of the information to be

collected; and (4) Ways to minimize the

burden of the collection of information

on those who are to respond, including

the use of appropriate automated,
37404 Federal Register / Vol. 63, No. 132 / Friday, July 10, 1998 / Notices

electronic, mechanical, or other

technological collection techniques or

other forms of information technology.

Direct Comments to OMB

Written comments and/or suggestions

regarding the items contained in this

notice, especially regarding the

estimated public burden and associated

response time, should be directed to the:

Office of Management and Budget,

Office of Regulatory Affairs, New

Executive Office Building, Room 10235,

Washington, D.C. 20503, Attention:

Desk Officer for NIH. To request more

information on the proposed project or

to obtain a copy of the data collection

plans and instruments, contact: Charles

MacKay, Ph.D., NIH Project Clearance

Officer, Division of Grants Policy, Office

of Policy for Extramural Research

Administration, OER, NIH, Rockledge II,

Rm. 2196, 6701 Rockledge Dr.,

Bethesda, MD 20892–7730, or call nontoll free at (301) 435–0978 or E-mail

your request, including your address to:

mackayc@odrockm1.od.nih.gov.

Comments Due Date

Comments regarding this information

collection are best assured of having

their full effect if received on or before

August 10, 1998.

Dated: June 30, 1998.

Diana Jaeger,

Director, Division of Grants Policy, Office of

Policy for Extramural Research

Administration, OER, NIH.

[FR Doc. 98–18321 Filed 7–9–98; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Arthritis and

Musculoskeletal and Skin Diseases;

Notice of Closed Meetings

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

meetings.

The meetings will be closed to the

public in accordance with the

provisions set forth in section 552b(c)(4)

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

amended. The grant applications and

the discussions could disclose

confidential trade secrets or commercial

property such as patentable material,

and personal information concerning

individuals associated with the grant

applications, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Name of Committee: National Institute of

Arthritis and Musculoskeletal and Skin

Diseases Special Emphasis Panel, Clinical

Trials Musculoskeletal.

Date: August 3, 1998.

Time: 10:00 a.m. to 1:00 p.m.

Place: To review and evaluate grant

applications.

Place: Natcher Bldg., 45 Center Drive,

Room 5AS25N, Bethesda, MD 20892,

(Telephone Conference Call).

Contact Person: John R. Lymangrover,

Scientific Review Administrator, NIAMS, 45

Center Drive, Room 5AS 25, Bethesda, MD

20892–650, (301) 594–4952.

Name of Committee: National Institute of

Arthritis and Musculoskeletal and Skin

Diseases Special Emphasis Panel,

Osteoporosis Center.

Date: August 10, 1998.

Time: 10 a.m. to 11:00 a.m.

Agenda: To review and evaluate grant

applications.

Place: Natcher Bldg., 45 Center Drive,

Room 5AS25N, Bethesda, MD 20892,

(Telephone Conference Call).

Contact Person: John R. Lymangrover,

Scientific Review Administrator, NIAMS, 45

Center Drive, Room 5AS 25, Bethesda, MD

20892–650, (301) 594–4952.

(Catalogue of Federal Domestic Assistance

Program Nos. 93.846, Arthritis,

Musculoskeletal and Skin Diseases Research,

National Institutes of Health, HHS)

Dated: July 2, 1998.

LaVeen Ponds,

Acting Committee Management Officer, NIH.

[FR Doc. 98–18317 Filed 7–9–98; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of General Medical

Sciences; 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

meeting.

The meeting will be closed to the

public in accordance with the

provisions set forth in sections

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

as amended. The grant applications and

the discussions could disclose

confidential trade secrets or commercial

property such as patentable material,

and personal information concerning

individuals associated with the grant

applications, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Name of Committee: National Institute of

General Medical Sciences Special Emphasis

Panel National Research Service Award.

Date: July 17, 1998.

Time: 9:00 a.m. to 2:00 p.m.

Agenda: To review and evaluate grant

applications.

Place: Holiday Inn Chevy Chase, 5520

Wisconsin Avenue, Chevy Chase, MD 20815.

Contact Person: Bruce K. Wetzel, Scientific

Review Administrator, Office of Scientific

Review, NIGMS, Natcher Building, Room

1AS–19, Bethesda, MD 20892, (301) 594–

3907.

This notice is being published less than 15

days prior to the meeting due to the timing

limitations imposed by the review and

funding cycle.

(Catalogue of Federal Domestic Assistance

Program Nos. 93.375, Minority Biomedical

Research Support; 93.821, Cell Biology and

Biophysics Research; 93.859, Phamacology,

Physiology, and Biological Chemistry

Research; 93.862, Genetics and

Developmental Biology Research; 93.88,

Minority Access to Research Careers; 93.96,

Special Minority Initiatives, National

Institutes of Health, HHS)

Dated: July 2, 1998.

LaVeen Ponds,

Acting Committee Management Officer, NIH.

[FR Doc. 98–18318 Filed 7–9–98; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Public Health Service

National Toxicology Program; Notice

of International Workshop to ‘‘Evaluate

Research Needs on the Use and Safety

of Medicinal Herbs’’

The Workshop will be held at the

National Institute of Environmental

Health Sciences, Conference Facility in

Research Triangle Park, North Carolina

September 23 and 24 1998 from 8:30 to

5:00 each day.

Background

Herbal medicines and dietary

supplements account for one of the

fastest growing markets in U.S.

pharmacies and constitute a multibillion dollar industry. It is estimated

that as many as 1,500 botanicals are sold

in the U.S. as dietary supplements or

ethnic traditional medicines. It is

further estimated that greater than 50%

of the U.S. population uses one or more

dietary supplements including

medicinal herbs. Medicinal herbs are

not, however, subject to the same testing

for efficacy or safety mandated for

prescription or over-the-counter drugs.

Given the increasing use of some

medicinal herbs and the paucity of

toxicological data, this workshop will

bring together a panel of national and

international experts to discuss the use

of the medicinal herbs and dietary

supplements and to establish research

needs that address public health