Federal Register / Vol. 61, No. 103 / Tuesday, May 28, 1996 / Notices 26523

CDC suggests the following to get more

timely responses to any questions: use

Internet/email, follow all instructions in

this announcement, and leave messages

on the contact person’s voice mail.

Potential applicants may obtain a

copy of Healthy People 2000 (Full

Report, Stock No. 017–001–00474–0) or

Healthy People 2000 (Summary Report,

Stock No. 017–001–00473–1) referenced

in the Introduction through the

Superintendent of Documents,

Government Printing Office,

Washington, DC 20402–9325, telephone

(202) 512–1800.

Dated: May 17, 1996.

Diane D. Porter,

Acting Director, National Institute for

Occupational Safety and Health, Centers for

Disease Control and Prevention (CDC).

[FR Doc. 96–13196 Filed 5–24–96; 8:45 am]

BILLING CODE 4163–19–P

Food and Drug Administration

[Docket No. 95N–0200]

Guidance on Applications for Products

Comprised of Living Autologous Cells

Manipulated Ex Vivo and Intended for

Structural Repair or Reconstruction;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a guidance entitled

‘‘Guidance on Applications for Products

Comprised of Living Autologous Cells

Manipulated Ex Vivo and Intended for

Structural Repair or Reconstruction.’’

The guidance was prepared by the

Center for Biologics Evaluation and

Research (CBER) in consultation with

the Center for Devices and Radiological

Health. The document is intended to

provide guidance on FDA’s approach to

the regulation of living autologous cells

manipulated ex vivo and intended for

structural repair or reconstruction

(Manipulated Autologous cells or MAS

cells). The agency is also inviting

comments on the guidance.

DATES: Written comments by August 26,

1996.

ADDRESSES: Submit written requests for

single copies of the guidance entitled

‘‘Guidance on Applications for Products

Comprised of Living Autologous Cells

Manipulated Ex Vivo and Intended for

Structural Repair or Reconstruction’’ to

the Division of Congressional and

Public Affairs (HFM–44), 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 that office in processing

your requests. The guidance may also be

obtained by mail or FAX by calling the

CBER Voice Information System at 1–

800–835–4709.

Persons with access to the INTERNET

may obtain the document in several

ways. Users of ‘‘Web Browser’’ software,

such as Mosaic, Netscape, or Microsoft

Internet Explorer may obtain this

document via the World Wide Web by

using the following Uniform Resource

Locators:

http://www.fda.gov/cber/cberftp.html

ftp://ftp.fda.gov/CBER/

The document may also be obtained

via File Transfer Protocol (FTP).

Requestors should connect to FDA’s

FTP Server,

FTP.FDA.GOV(192.73.61.21). CBER

documents are maintained in a

subdirectory called ‘‘CBER’’ on the

server. Logins with the user name of

anonymous are permitted, and the

user’s e-mail address should be sent as

the password. The ‘‘READ.ME’’ file in

that subdirectory describes the available

documents that may be available as an

ASCII text file (*.TXT), or a WordPerfect

5.1 or 6.x document (*.w51,wp6), or

both. Finally, the guidance can be

obtained by ‘‘bounce-back e-mail’’. A

message should be sent to:

GDEXV@al.cber.fda.gov’’.

Submit written comments on the

guidance to the Dockets Managements

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. Requests and

comments should be identified with the

docket number found in brackets in the

heading of this document. A copy of the

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.

FOR FURTHER INFORMATION CONTACT:

Sharon A. Carayiannis, Center for

Biologics Evaluation and Research

(HFM–630), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852–1448, 301–594–

3074.

SUPPLEMENTARY INFORMATION:

FDA had recently become aware of

the clinical use of MAS cell products.

MAS cells are defined as cells derived

from a patient’s tissues, which are

manipulated ex vivo, and then

implanted locally into the same patient

with the intent of providing repair or

reconstruction of a structure. The repair

and reconstruction does not involve

systemic action by the MAS cell

product. Examples of MAS cells include

chondrocytes expanded ex vivo and

implanted in focal cartilage defects (see

60 FR 36808 at 36809 for additional

information and references). The

commercialization and distribution of

expanded cartilage cells to provide a

potential solution to a relatively

common medical injury suggested that

numerous patients could be receiving

these cells within a short period of time.

In light of the potential public health

significance of the MAS cell products,

the growth of a commercial industry

potentially affecting a large number of

patients, and the need to decide which

existing regulatory authorities (e.g.,

device versus biologics) would be

appropriate to apply or whether a new

regulatory framework was required, the

agency held a public hearing on

November 16 and 17, 1995 (60 FR

36808). The intent of the meeting was to

solicit information on the nature and

diversity of these products, and to

receive comments on the formulation

and implementation of any new

regulatory requirements. The public

hearing had 8 panels with 24 speakers,

and there was general consensus that

the establishment, the production

process, and the MAS cell products

should be of the highest quality. The

speakers and attendees also agreed that

MAS cell products should benefit the

patient, but there was little consensus

on the appropriate mechanism that

should be used to show this benefit.

In the Federal Register of March 7,

1996 (61 FR 9185), after reviewing the

comments and further internal

discussions, the agency published a

notice announcing a Commissioner’s

roundtable to be held on March 15,

1996. The roundtable was held to

present the elements of a planned

regulatory framework intended to

ensure patient safety and to demonstrate

patient benefit, while accommodating

the development of these therapies and

the need for a flexible regulatory

approach. Many of the concepts

presented at the roundtable were

derived from ongoing FDA Reinventing

Government (REGO) initiatives. In the

same Federal Register notice, FDA also

invited the submission of written

comments concerning FDA’s draft plan

for the regulation of MAS cells. Based

on the discussions at the March 15,

1996, roundtable and on a review of all

comments received, FDA has decided

that, in light of the existing and

increased flexibility provided by REGO

initiatives, FDA will apply the

regulatory framework as detailed and

explained in the guidance. CBER is
26524 Federal Register / Vol. 61, No. 103 / Tuesday, May 28, 1996 / Notices

designated as the agency component

with primary jurisdiction for the

premarket review and regulation of

MAS cell products. The products are

subject to licensure as biological

products under section 351 of the Public

Health Service Act (42 U.S.C. 262).

The guidance document includes

discussions on the following: (1)

Background and recent events; (2)

regulatory plan, including: A summary

and discussions of products to be

regulated, registration and inspection of

establishments, clinical studies,

investigational phase and requirements

for premarket approval, cost recovery,

marketing application, chemistry,

manufacturing and controls section of a

biologics license application,

formulation of an intercenter working

group, contracting of manufacture, lot

release, and current good manufacturing

practice requirements; (3) registration

and application submission; and (4)

submission of comments.

As with other procedural guidance

documents, FDA does not intend this

guidance to be all-inclusive. Alternative

approaches could be warranted in

specific situations, and certain aspects

might not be applicable in all situations.

If an applicant believed a procedure

described in this guidance was

inapplicable to a specific situation for a

particular product, the applicant could

provide, for CBER’s consideration,

information supporting an alternative

process. If an applicant chooses to use

an alternative process, the applicant

may wish to discuss the matter further

with the agency to prevent expenditure

of money and resources on activities

that later might be determined to be

inappropriate to FDA. Although this

guidance does not create or confer any

rights for or on any person, and does not

operate to bind FDA or the public, it

does represent the agency’s current

thinking on the regulation of MAS cell

products.

Interested persons may, on or before

(insert date 90 days after date of

publication in the Federal Register),

submit written comments on the

guidance to the Dockets Management

Branch (address above). Two copies of

any comments are to be submitted,

except that individuals may submit one

copy. Comments and information 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.

Received comments on this document

will be considered in determining

whether revisions to the guidance are

warranted.

Dated: May 22, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–13386 Filed 5–23–96; 11:13 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

Office of the Assistant Secretary for

Housing; Notice of Proposed

Information Collection for Public

Comment

[Docket No. FR–3917–N–78]

AGENCY: Office of the Assistant

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: July 29, 1996.

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, Housing, Department of

Housing & Urban Development, 451—

7th Street, SW., Room 9116,

Washington, DC 20410.

FOR FURTHER INFORMATION CONTACT:

Betty Belin, Telephone number (202)

708–0614 (this is not a toll-free number)

for copies of the proposed forms and

other available documents.

SUPPLEMENTARY INFORMATION: The

Department will submit 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).

The 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: Multifamily

Coinsurance Claims Package (f).

OMB Control Number: 2502–0420.

Description of the need for the

information and proposed use: Under

Statue 12 USC 1715z–9 and Title II,

Section 244 of the National Housing Act

authorizes the Secretary of HUD to

coinsure eligible multifamily mortgages

against default. In addition to

complying with statutory requirements,

the information collected is used by

HUD to determine the claim amount

due the mortgages. The main purpose

for the forms is for lenders to file a

claim for insurance benefits.

Agency form numbers: HUD 27008,

27009B, 27009D, 27009F.

Members of affected public:

Mortgagees participating in Section

233(f).

An estimation of the total numbers of

hours needed to prepare the information

collection is 5, the number of

respondents is 5, frequency of response

is 1, and the hours of response is 5.

Status of the proposed information

collection: Reinstatement with change.

Authority: Section 3506 of the Paperwork

Reduction Act of 1995, 44 U.S.C. Chapter 35,

as amended.

Dated: May 20, 1996.

Nicolas P. Retsinas,

A/S Secretary for Housing—Federal Housing

Commissioner.

[FR Doc. 96–13238 Filed 5–24–96; 8:45 am]

BILLING CODE 4210–27–M

[Docket No. FR–3917–N–81]

Office of Administration; Submission

for OMB Review; Comment Request

AGENCY: Office of Administration, HUD.

ACTION: Notice.

SUMMARY: The proposed information

collection requirement described below

has been 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: June 27,

1996.

ADDRESSES: Interested persons are

invited to submit comments regarding

this proposal. Comments must be

received within thirty (30) days from the

date of this Notice. Comments should