40128 Federal Register / Vol. 63, No. 143 / Monday, July 27, 1998 / Notices

and recommendations on how to

prepare EA’s.

DATES: Written comments may be

submitted at any time.

ADDRESSES: Copies of this guidance for

industry are available on the Internet at

‘‘http://www.fda.gov/cder/guidance/

index.htm’’ or ‘‘http://www.fda.gov/

cber/guidelines.htm’’. Submit written

requests for single copies of the

guidance to the Drug Information

Branch (HFD–210), Center for Drug

Evaluation and Research, Food and

Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857 or Office of

Communication, Training and

Manufacturers Assistance (HFM–40),

Center for Biologics Evaluation and

Research, Food and Drug

Administration, 1401 Rockville Pike,

Rockville MD 20852–1448. Send one

self-addressed adhesive label to assist

the office in processing your requests.

Submit written comments on the

guidance to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Nancy B. Sager, Center for Drug

Evaluation and Research (HFD–357),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–594–5629, or Daniel C. Kearns,

Center for Biologics Evaluation and

Research (HFM–206), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448, 301–827–

3031.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of a

guidance for industry entitled

‘‘Environmental Assessment of Human

Drug and Biologics Applications.’’ The

National Environmental Policy Act of

1969 (NEPA) requires all Federal

agencies to assess the environmental

impacts of their actions and to ensure

that the interested and affected public is

informed of environmental analyses.

FDA is required under NEPA to

consider the environmental impact of

approving drug and biologics

applications as an integral part of its

regulatory process. Under the

President’s reinventing Government

initiatives announced in April 1995,

FDA reevaluated and revised its

environmental regulations to reduce the

number of EA’s required to be submitted

by industry and, consequently, the

number of findings of no significant

impact prepared by the agency under

NEPA.

In the Federal Register of April 3,

1996 (61 FR 14922) (republished May 1,

1996 (61 FR 19476)), FDA issued for

public comment a notice of proposed

rulemaking that proposed additional

categorical exclusions for those actions

the Center for Drug Evaluation and

Research (CDER) and the Center for

Biologics Evaluation and Research

(CBER) have determined normally do

not individually or cumulatively have a

significant effect on the quality of the

human environment. The final rule was

published in the Federal Register of

July 29, 1997 (62 FR 40570), and became

effective August 28, 1997. This guidance

is based on the final rule and supersedes

CDER’s ‘‘Guidance for Industry For the

Submission of an Environmental

Assessment in Human Drug

Applications and Supplements,’’ which

published in November 1995.

In the Federal Register of February

12, 1998 (63 FR 7174), FDA announced

the availability of a draft version of this

guidance. The February 12, 1998,

document gave interested persons an

opportunity to submit comments

through April 13, 1998. All comments

received during the comment period

have been carefully reviewed and

incorporated, where appropriate, in this

revised guidance.

FDA’s regulations in part 25 (21 CFR

part 25) specify that environmental

assessments must be submitted as part

of certain new drug applications,

abbreviated applications, applications

for marketing approval of a biologic

product, supplements to such

applications, investigational new drug

applications and for various other

actions (see § 25.20), unless the action

qualifies for a categorical exclusion.

This guidance provides information

on when an EA should be submitted

and recommendations on how to

prepare EA’s for submission to CDER

and CBER for these drug or biologics

applications. Topics covered include:

(1) When categorical exclusions apply,

(2) when to submit an EA, (3) the

content and format of EA’s, (4) specific

guidance for the environmental issues

that are most likely to be associated

with human drugs and biologics, (5) test

methods, (6) an applicant’s treatment of

confidential information submitted in

support of an EA, and (7) master files for

drugs and biologics.

This guidance is a level 1 guidance

consistent with FDA’s good guidance

practices (62 FR 8961, February 27,

1997). It represents the agency’s current

thinking on environmental assessment

of human drug and biologics

applications. 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.

Interested persons may, at any time,

submit to the Dockets Management

Branch (address above) written

comments on the guidance. 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 may be seen in the office

above between 9 a.m. and 4 p.m.,

Monday through Friday.

Dated: July 20, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–19900 Filed 7–24–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0563]

CDRH Draft Guidance For Industry:

Contents of a Product Development

Protocol; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guidance entitled

‘‘CDRH Guidance for Industry—

Contents of a Product Development

Protocol; Draft’’. This draft guidance is

not final nor is it in effect at this time.

This document provides guidance on

the content of product development

protocol (PDP) applications, expected

actions and timeframes in the

development of a product under a PDP,

and how changes during the course of

product development under a PDP

should be handled.

DATES: Written comments must be

received by October 26, 1998.

ADDRESSES: Submit written requests for

single copies on a 3.5’’ diskette of the

draft guidance document entitled

‘‘CDRH Guidance for Industry—

Contents of a Product Development

Protocol; Draft’’ to the Division of Small

Manufacturers Assistance (HFZ–220),

Center for Devices and Radiological

Health, Food and Drug Administration,

1350 Piccard Dr., Rockville, MD 20850.

Send two self-addressed adhesive labels

to assist that office in processing your

request, or fax your request to 301–443–

8818. Written comments concerning this

document must be submitted to the

Dockets Management Branch (HFA–
Federal Register / Vol. 63, No. 143 / Monday, July 27, 1998 / Notices 40129

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852. Comments should be

identified with the document number

found in brackets in the heading of this

document. See the SUPPLEMENTARY

INFORMATION section for information

on electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT:

For general information on the PDP

process, or to comment on this

guidance, please contact: Kathy M.

Poneleit, Center for Devices and

Radiological Health (HFZ–402),

Food and Drug Administration,

9200 Corporate Blvd., Rockville,

MD 20857, 301–594–2186.

For information concerning the design

control and GMP aspects of this

guidance, please contact: Sandy

Weininger, Center for Devices and

Radiological Health (HFZ–141),

Food and Drug Administration,

9200 Corporate Blvd., Rockville,

MD 20857, 301–443–2536, ext. 34.

SUPPLEMENTARY INFORMATION:

I. Background

Section 515(f) of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C.

360e(f)) provides an alternative to the

investigational device exemption (IDE)

and PMA processes for class III devices

subject to premarket approval. This

alternative process, PDP, was not

implemented during the early years of

FDA’s medical device program because

it was considered potentially complex

and there was a need to focus attention

on implementing the core provisions of

the Medical Device Amendments of

1976, such as the IDE, premarket

approval, 510(k), good manufacturing

practices, and problem reporting

requirements.

This document provides guidance on

the content of PDP applications,

expected actions and timeframes in the

development of a product under a PDP,

and how changes during the course of

product development under a PDP

should be handled. This draft guidance

also provides a framework for

interaction between FDA and the

applicant; but, because of the wide

range of devices that may be developed

under the PDP authority, it is unlikely

that every element addressed in the

guidance will apply to any given device.

II. Significance of Guidance

This draft guidance document

represents the agency’s current thinking

on the PDP process and the relative

duties and responsibilities of the agency

and the applicant. 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

applicable statute, regulations, or both.

The agency has adopted good

guidance practices (GGP’s), which set

forth the agency’s policies and

procedures for the development,

issuance, and use of guidance

documents (62 FR 8961, February 27,

1997). This draft guidance document is

issued as a Level 1 guidance consistent

with GGP’s.

III. Electronic Access

‘‘CDRH Guidance for Industry—

Contents of a Product Development

Protocol; Draft’’ is available by fax from

CDRH’s Facts-On-Demand (FOD) system

at 800–899–0381 or 301–827–0111 from

a touch-tone telephone. At the first

voice prompt, press 1 to access DSMA

Facts, at the second voice prompt, press

2, and then enter the document number

473 followed by the pound sign (#).

Then follow the remaining voice

prompts to complete your request.

Persons interested in obtaining a copy

of the draft guidance may also do so

using the World Wide Web (WWW).

CDRH maintains an entry on the WWW

for easy access to information including

text, graphics, and files that may be

downloaded to a personal computer

with access to the WWW. Updated on

a regular basis, the CDRH Home Page

includes ‘‘Guidance for Industry—

Contents of a Product Development

Protocol; Draft’’ device safety alerts,

Federal Register reprints, information

on premarket submissions (including

lists of approved applications and

manufacturers’ assistance, information

on video conferencing and electronic

submissions, mammography matters,

and other device-oriented information.

The CDRH home page may be accessed

at ‘‘http://www.fda.gov/cdrh’’. The

‘‘Guidance for Industry—Contents of a

Product Development Protocol; Draft’’

will be available at ‘‘http://

www.fda.gov/cdrh/pdp/.html’’.

A text-only version of the CDRH Web

site is also available from a computer or

VT-100 compatible terminal by dialing

800–222–0185 (terminal settings are 8/

1/N). Once the modem answers, press

Enter several times and then select

menu choice 1: FDA BULLETIN BOARD

SERVICE. From there follow

instructions for logging in, and at the

BBS TOPICS PAGE, arrow down to the

FDA home page (do not select the first

CDRH entry). Then select Medical

Devices and Radiological Health. From

there select CENTER FOR DEVICES

AND RADIOLOGICAL HEALTH for

general information, or arrow down for

specific topics.

IV. Comments

Interested persons may, on or before

October 26, 1998, submit to the Dockets

Management Branch (address above)

written comments regarding this draft

guidance. 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

document and received comments may

be seen in the Dockets Management

Branch between 9 a.m. and 4 p.m.,

Monday through Friday.

Dated: July 9, 1998.

D.B. Burlington,

Director, Center for Devices and Radiological

Health.

[FR Doc. 98–19899 Filed 7–24–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0545]

Draft Guidance for Industry:

Recommendations for Collecting Red

Blood Cells by Automated Apheresis

Methods; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guidance

document entitled ‘‘Guidance for

Industry: Recommendations for

Collecting Red Blood Cells by

Automated Apheresis Methods.’’ The

draft guidance document describes the

recommended donor suitability criteria

and the licensing provisions for the

collection of red blood cells using

automated methods. The draft guidance

document provides recommendations to

blood establishments for the use of FDA

cleared automated blood cell separators

for the collection of both single and

double units of red blood cells.

DATE: Written comments may be

submitted at any time, however,

comments should be submitted by

September 25, 1998, to ensure their

adequate consideration in preparation of

the final document.

ADDRESSES: Submit written requests for

single copies of ‘‘Guidance for Industry:

Recommendations for Collecting Red

Blood Cells by Automated Apheresis

Methods’’ to the Office of

Communication, Training, and

Manufacturers Assistance (HFM–40),