15936 Federal Register / Vol. 60, No. 59 / Tuesday, March 28, 1995 / Notices

meetings in 1991 and 1992. The trial

phase of the committee review process

confirmed the agency’s view that the

divisions in CDER impose clinical holds

in a matter that is generally consistent

with FDA’s procedural requirements

and that holds are imposed on

scientifically supportable grounds.

The clinical hold committee review

process is now a regular, ongoing

program. The review procedure of the

committee is designed to afford an

opportunity for a sponsor who does not

wish to seek formal reconsideration of a

pending hold to have that hold

considered ‘‘anonymously.’’ The

committee consists of senior managers

in CDER, a senior official from the

Center for Biologics Evaluation and

Research, and FDA’s Chief Mediator and

Ombudsman. The committee now meets

semiannually. The committee last met

in October 1994.

Clinical holds to be reviewed will be

chosen randomly. In addition, the

committee will review holds proposed

for review by drug sponsors. In general,

a drug sponsor should consider

requesting review when it disagrees

with the agency’s scientific or

procedural basis for the decision.

Requests for committee review of a

clinical hold should be submitted to

FDA’s Chief Mediator and Ombudsman,

who is responsible for selecting clinical

holds for review. The committee and

CDER staff, with the exception of the

Chief Mediator and Ombudsman, are

never advised, either in the review

process or thereafter, which of the holds

were randomly chosen and which were

submitted by sponsors. The committee

will evaluate the selected clinical holds

for scientific content and consistency

with agency regulations and CDER

policy.

The meetings of the review committee

are closed to the public because

committee discussions deal with

confidential commercial information.

Summaries of the committee

deliberations, excluding confidential

commercial information, will be

available from the Chief Mediator and

Ombudsman. If the status of a clinical

hold changes following the committee’s

review, the appropriate division will

notify the sponsor.

FDA invites drug companies to

submit to the FDA Chief Mediator and

Ombudsman the name and IND number

of any investigational new drug trial

that was placed on clinical hold during

the past 12 months that they want the

committee to review at its June meeting.

Submissions should be made by April

27, 1995, to Amanda B. Pedersen, FDA

Chief Mediator and Ombudsman

(address above).

Dated: March 18, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95–7575 Filed 3–27–95; 8:45 am]

BILLING CODE 4160–01–F

National Institutes of Health

Division of Research Grants; 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 Division

of Research Grants Special Emphasis

Panel (SEP) meetings:

Purpose/Agenda

To review individual grant applications.

Name of SEP: Behavioral and

Neurosciences.

Date: April 12, 1995.

Time: 2 p.m.

Place: NIH, Westwood Building, Room

303, Telephone Conference.

Contact Person: Dr. Joe Marwah, Scientific

Review Administrator, 5333 Westbard Ave.,

Room 303, Bethesda, MD 20892, (301) 594–

7158.

Name of SEP: Biological and Physiological

Sciences.

Date: April 18, 1995.

Time: 12:30 p.m.

Place: NIH, Westwood Building, Room

417B, Telephone Conference.

Contact Person: Dr. Gerald Greenhouse,

Scientific Review Admin., 5333 Westbard

Ave., Room 417B, Bethesda, MD 20892, (301)

594–7385.

Name of SEP: Multidisciplinary Sciences.

Date: April 26, 1995.

Time: 10 a.m.

Place: NIH, Westwood Building, Room

2A15, Telephone Conference.

Contact Person: Dr. Houston Baker,

Scientific Review Administrator, 5333

Westbard Ave., Room 2A15, Bethesda, MD

20892, (301) 594–7374.

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.

This notice is being published less than 15

days prior to the meeting due to the urgent

need to meet timing limitations imposed by

the grant review cycle.

(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,

83.892, 93.893, National Institutes of Health,

HHS)

Dated: March 21, 1995.

Susan K. Feldman,

Committee Management Officer, NIH.

[FR Doc. 95–7515 Filed 3–27–95; 8:45 am]

BILLING CODE 4140–01–M

Public Health Service

National Institutes of Health; Statement

of Organization, Functions, and

Delegations of Authority

Part H, Chapter HN (National

Institutes of Health) of the Statement of

Organization, Functions, and

Delegations of Authority for the

Department of Health and Human

Services (40 FR 22859, May 27, 1975, as

amended most recently at 59 FR 60997–

8, November 29, 1994) is amended to

reflect the reorganization of the Office of

the Director, National Institute of

Allergy and Infectious Diseases (OD/

NIAID). The reorganization consists of

the following: (1) Retitle the (a) Office

of Administrative Management

(HNM17) to the Office of Administrative

Services (HNM17); (b) Financial

Management and Information Systems

Branch (HNM173) to the Office of

Financial Management (HNMI2); and (c)

Personnel Management Branch

(HNMI74) to the Office of Human

Resources Management (HNM14); (2)

establish the Office of Technology

Information Systems (HNM15); and (3)

transfer the functions of the Office of

Tropical Medicine and International

Research (OTMIR) (HNM19) to the

Division of Microbiology and Infectious

Diseases (HNM5) and abolish the

OTMIR. This reorganization will enable

the NIAID to better fulfill its mission by

restructuring the OD/NIAID to better

integrate related program areas and

streamline operations.

Section HN–B, Organization and

Functions is amended as follow: (1)

Under the heading Office of the Director

(HNM1), National Institute of Allergy

and Infectious Diseases (HNM), insert

the following:

Office of Financial Management

(HNM12). (1) Serves as principal advisor

to the Institute Director, Deputy Director

for Management and Operations, and

Division Directors in the financial

management aspects of the planning,

formulation, execution, and evaluation

of the Institute’s research grant, training,

and intramural research programs; (2)

collaborates with program planning staff

in the development and coordination of

the Institute programs with the budget

process; (3) formulates and monitors the

Institute’s financial management

program and establishes a system of

effective control of funds utilized