19268 Federal Register / Vol. 63, No. 74 / Friday, April 17, 1998 / Notices

rendered sterile. The document also

identifies CGMP’s for the manufacture

of API’s used in the production of drug

products for clinical trials. The draft guidance incorporates the

following two fundamental concepts in

API production: (1) Application of

CGMP controls to all steps in the

manufacturing process, beginning with

the use of starting materials; and (2)

validation of those steps determined to

be critical to the quality and purity of

the final API. The guidance clarifies the

agency’s expectations regarding

application of CGMP’s (i.e., extent of

written instructions, in-process controls,

sampling, testing, monitoring, and

documentation) to different steps of an

API process. This draft guidance represents the

agency’s current thinking on the

manufacture and control of API’s. 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 requirement

of the applicable statute, regulations, or

both.

Written requests for single copies of

the guidance ‘‘Manufacturing,

Processing, or Holding Active

Pharmaceutical Ingredients’’ should be

submitted to the Drug Information

Branch (HFD–210), Center for Drug

Evaluation and Research, Food and

Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857. Send one

self-addressed adhesive label to assist

that office in processing your requests.

Requests should be identified with the

docket number found in brackets in the

heading of this document. A copy the

draft guidance and received comments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.

Dated: April 14, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–10312 Filed 4–15–98; 11:29 am]

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DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

HRSA Competitive Grants Preview;

Long Term Training in Leadership

Education in Neurodevelopmental and

Related Disabilities (LEND)

AGENCY: Health Resources and Services

Administration, HHS.

ACTION: Notice of extension of deadline

date.

SUMMARY: This notice extends the due

date for applications for Long Term

Training in Leadership Education in

Neurodevelopmental and Related

Disabilities (LEND) program grants,

previously published in the Federal

Register on October 9, 1997 as part of

the General Notice: Availability of the

HRSA Competitive Grants Preview (62

FR 52894–52914). Authorized under

Title V of the Social Security Act, these

LEND grants are intended to improve

the health status of infants, children,

and adolescents with, or at risk for,

neurodevelopmental and related

disabilities, including mental

retardation, neurodegenerative and

acquired neurological disorders, and

multiple handicaps. The LEND

programs prepare health professionals

to assist children and their families to

achieve their developmental potentials

by forging a community-based

partnership of health resources and

community leadership.

In the table on page 52893 and on

page 52909 in the third column, the

application deadline date published in

the Federal Register has been extended

to October 1, 1998.

Dated: April 13, 1998.

James J. Corrigan,

Acting Associate Administrator for

Management and Program Support.

[FR Doc. 98–10202 Filed 4–16–98; 8:45 am]

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DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Availability of the HRSA Competitive

Grants Preview; Correction

AGENCY: Health Resources and Services

Administration, HHS.

ACTION: Correction of deadline date.

SUMMARY: In notice FR Doc. 97–26645,

in the issue of Thursday, October 9,

1997, make the following corrections:

In the table on page 52893, in the

section HIV/AIDS Programs, under

‘‘Ryan White Title IV Adolescent

Services,’’ the deadline date is corrected

to read ‘‘June 19, 1998.’’

On page 52898, in column 2, in the

fourteenth line, the deadline date is

corrected to read ‘‘June 19, 1998.’’

Dated: April 13, 1998.

James J. Corrigan,

Acting Associate Administrator for

Management and Program Support.

[FR Doc. 98–10201 Filed 4–16–98; 8:45 am]

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DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Advisory Council; Notice of Meeting

In accordance with section 10(a)(2) of

the Federal Advisory Committee Act

(Pub. L. 92–463), announcement is

made of the following National

Advisory body scheduled to meet

during the month of June 1998.

Name: Maternal and Child Health Research

Grants Review Committee.

Date and Time: June 17–19, 1998; 8:00

a.m.–5:00 p.m.

Place: The Executive Boardroom, the

Bethesda Ramada, 8400 Wisconsin Avenue,

Bethesda, Maryland.

The meeting is open to the public on

Wednesday, June 17, 1998, 9:00 a.m. to 10:00

a.m. Closed for the remainder of meeting.

Agenda: The open portion of the meeting

will cover opening remarks by the Director,

Division of Systems, Education and Science,

who will report on program issues,

congressional activities, and other topics of

interest to the field of maternal and child

health. The meeting will be closed to the

public on Wednesday, June 17, 1998 from

10:00 a.m. for the remainder of the meeting

for the review of grant applications. The

closing is in accordance with the provisions

set forth in section 552b(c)(6), Title 5 U.S.C.,

and the Determination by the Associate

Administrator for Management and Program

Support, Health Resources and Services

Administration, pursuant to Public Law 92–

463.

Anyone wishing to obtain a roster of

members, minutes of meetings, or other

relevant information should write or contact

Gontran Lamberty, Dr. P.H., Executive

Secretary, Maternal and Child Health Grants

Review Committee, Room 18A–55, Parklawn

Building, 5600 Fishers Lane, Rockville,

Maryland 20857, or by telephone at (301)

443–2190.

Agenda items are subject to change as

priorities dictate.

Dated: April 10, 1998.

Jane M. Harrison,

Acting Director, Division of Policy Review

and Coordination.

[FR Doc. 98–10203 Filed 4–16–98; 8:45 am]

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