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 This draft guidance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This draft guidance document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),
40130 Federal Register / Vol. 63, No. 143 / Monday, July 27, 1998 / Notices

Center for Biologics Evaluation and

Research (CBER), 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.

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.

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:

Astrid L. Szeto, Center for Biologics

Evaluation and Research (HFM–17),

Food and Drug Administration, 1401

Rockville Pike, 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:

Recommendations for Collecting Red

Blood Cells by Automated Apheresis

Methods.’’ The draft guidance document

is intended to provide specific

recommendations on donor suitability

criteria for allogenic and autologous red

blood cell donations, on standard

operating procedures, and

recordkeeping, and describes

registration and licensing procedures for

the manufacture of double units of red

blood cells or single units of red blood

cells plus up to two units of fresh frozen

plasma.

This draft guidance document

represents the agency’s current thinking

with regard to collecting red blood cells

by automated apheresis methods. 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 document to

be all-inclusive and cautions that not all

information may be applicable to all

situations. This 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 this draft guidance

document. Written comments may be

submitted at any time, however,

comments should be submitted by

September 25, 1998, to ensure adequate

consideration in preparation of the final

document. Two copies of any comments

are to be submitted, except that

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

this 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) by

connecting to CBER at ‘‘http://

www.fda.gov/cber/guidelines.htm’’.

Dated: July 17, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–19897 Filed 7–24–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4356–N–14]

Notice of Proposed Information

Collection: Comment Request

AGENCY: Office of the Secretary for

Housing, HUD.

ACTION: Notice.

SUMMARY: The proposed information

collection requirement described below

will be submitted to the Office of

Management and Budget (OMB) for

review, as required by the Paperwork

Reduction Act. The Department is

soliciting public comments on the

subject proposal.

DATES: Comments due date: September

25, 1998.

ADDRESSES: Interested persons are

invited to submit comments regarding

this proposal. Comments should refer to

the proposal by name and/or OMB

Control Number and should be sent to:

Oliver Walker, Reports Management

Officer, Department of Housing and

Urban Development, 451 7th Street, SW,

Room 9116, Washington, DC 20410.

FOR FURTHER INFORMATION CONTACT: John

J. Coonts, Director, Office of Insured

Single Family Housing, telephone

number (202) 708–3046 (this is not a

toll-free number) for copies of the

proposed forms and other available

documents.

SUPPLEMENTARY INFORMATION: The

Department is submitting the proposed

information collection to OMB for

review, as required by the Paperwork

Reduction Act of 1995 (44 U.S.C.

Chapter 35, as amended).

This Notice is soliciting comments

from members of the public and

affecting agencies concerning the

proposed collection of information to:

(1) Evaluate whether the proposed

collection of information is necessary

for the proper performance of the

functions of the agency, including

whether the information will have

practical utility; (2) Evaluate the

accuracy of the agency’s estimate of the

burden of the proposed collection of

information; (3) Enhance the quality,

utility, and clarity of the information to

be collected; and (4) Minimize the

burden of the collection of information

on those who are to respond; including

through the use of appropriate

automated collection techniques or

other forms of information technology,

e.g., permitting electronic submission of

responses.

This Notice also lists the following

information:

Title of Proposal: Requirements for

Single Family Mortgage Instruments.

OMB Control Number, if applicable:

2502–0404.

Description of the need for the

information and proposed use: The

Single Family Mortgage Instruments are

the documents used to record the

mortgage (or deed of trust) and the

mortgage note (or deed of trust note).

These are public documents used to

protect both the interest of the mortgage

borrower as well as the mortgage lender.

Estimation of total number of hours

needed to prepare the information. The

estimated number of respondents are

8,300, the frequency of responses is

variable depending on business activity,

with 0.25 hours per response.

Agency form numbers, if applicable:

n/a.

Status of the proposed information

collection: Extension of currently

approved collection.

Authority: The Paperwork Reduction Act

of 1995, 44 U.S.C. Chapter 35, as amended.

Dated: July 20, 1998.

Ira G. Peppercorn,

General Deputy Assistant Secretary for

Housing.

[FR Doc. 98–19913 Filed 7–24–98; 8:45 am]

BILLING CODE 4210–27–M