Federal Register / Vol. 63, No. 74 / Friday, April 17, 1998 / Notices 19267

ANNUAL BURDEN ESTIMATES

Instrument Number of respondents

Number of responses per

respondent

Average burden hours per

response

Total burden

hours

New Hire Results Survey ................................................................................. 54 4 .5 108

Estimated Total Annual Burden

Hours: 108.

In compliance with the requirements

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

Paperwork Reduction Act of 1995, the

Administration for Children and

Families is soliciting public comment

on the specific aspects of the

information collection described above.

Copies of the proposed collection of

information can be obtained and

comments may be forwarded by writing

to the Administration for Children and

Families, Office of Information Services,

370 L’Enfant Promenade, SW,

Washington, DC 20447, Attn: ACF

Reports Clearance Officer. All requests

should be identified by the title of the

information collection.

The Department specifically requests

comments on: (a) Whether the proposed

collection of information is necessary

for the proper performance of the

functions of the agency, including

whether the information shall have

practical utility; (b) the accuracy of the

agency’s estimate of the burden of the

proposed collection of information; (c)

the quality, utility, and clarity of the

information to be collected; and (d)

ways to minimize the burden of the

collection of information on

respondents, including through the use

of automated collection techniques or

other forms of information technology.

Consideration will be given to

comments and suggestions submitted

within 60 days of this publication.

Dated: April 13, 1998.

Bob Sargis,

Acting Reports Clearance Officer.

[FR Doc. 98–10188 Filed 4–16–98; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0193]

Draft Guidance for Industry on

Manufacturing, Processing, or Holding

Active Pharmaceutical Ingredients;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guidance for

industry entitled ‘‘Manufacturing,

Processing, or Holding Active

Pharmaceutical Ingredients.’’ This draft

guidance is intended to provide

guidance on current good

manufacturing practices (CGMP’s) for

manufacturing, processing, packing, or

holding active pharmaceutical

ingredients (API’s). The draft guidance

is intended to help ensure the quality

and suitability of API’s for use in the

manufacture of drug products.

DATES: Written comments may be

submitted on the draft guidance by May

18, 1998. General comments on agency

guidances are welcome at any time.

ADDRESSES: Copies of this draft

guidance are available on the Internet at

http://www.fda.gov/cder/guidance/

index.htm or http://www.fda.gov/cber/

guidelines.htm.

Submit written comments on the draft

guidance to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857. 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.

FOR FURTHER INFORMATION CONTACT:

Edwin M. Rivera, Center for Drug

Evaluation and Research (HFD–322),

7520 Standish Pl., Rockville, MD 20855,

301–594–0095; John A. Eltermann,

Center for Biologics Evaluation and

Research (HFM–205), 1401 Rockville

Pike, Rockville, MD 20852, 301–827–

3031; or Jose R. Laureano, Center for

Veterinary Medicine (HFV–230), 7500

Standish Pl., Rockville, MD 20855, 301–

594–1785.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of a draft

guidance for industry entitled

‘‘Manufacturing, Processing, or Holding

Active Pharmaceutical Ingredients.’’ It

provides guidance on CGMP’s for the

manufacture, processing, packing, or

holding (i.e., storage) of API’s.

The draft guidance is a result of

extensive efforts that began in July 1995

when FDA decided to develop an

industry guidance for the manufacture

and control of API’s. An initial draft of

this guidance for industry was widely

distributed during 1996. It was reviewed

at a September 1996 international

conference on API’s in Canberra,

Australia, sponsored by the

Pharmaceutical Inspection Convention/

Pharmaceutical Inspection Convention

Scheme (PIC–PIC/S), and at the October

1996 annual FDA/Parenteral Drug

Association Forum in Bethesda, MD. It

also was distributed to numerous

pharmaceutical trade associations in a

letter from the Center for Drug

Evaluation and Research’s (CDER)

Office of Compliance, dated November

8, 1996. The initial draft was posted on

CDER’s website on November 12, 1996,

with a request for comments by

December 10, 1996. On December 9, the

deadline for comments was extended

until January 31, 1997. This draft

guidance incorporates recommendations

received at the two conferences and

comments from 27 organizations,

including API manufacturers, dosage

manufacturers, and pharmaceutical

associations.

At a February 4 and 5, 1998, meeting

of the International Conference on

Harmonisation (ICH) Steering

Committee in Tyson’s Corner, VA, FDA

supported the decision to develop

internationally harmonized guidance on

CGMP’s for API’s through the ICH

process. The agency agreed to

participate in an expert working group

that will review numerous guidance

documents developed by industry and

regulatory bodies to develop a single

harmonized ICH guidance. API/CGMP

guidances to be reviewed by the

working group include those prepared

by the European Chemical Industry

Council/European Federation of

Pharmaceutical Industries’ Association,

the Pharmaceutical Research and

Manufacturers of America, PIC–PIC/S,

and the World Health Organization.

This draft guidance will also be

considered by the working group.

The draft guidance applies to the

manufacture and control of drug and

biologic API’s for use in human and

veterinary drug products. In addition, it

applies to the later chemical isolation

and purification steps of API’s derived

from biological or fermentation

processes and to sterile API’s, but only

up to the point where the API is
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]

BILLING CODE 4160–01–F

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]

BILLING CODE 4160–15–P

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]

BILLING CODE 4160–15–P

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]

BILLING CODE 4160–15–P