Federal Register / Vol. 63, No. 2 / Monday, January 5, 1998 / Notices 235

by the Office of Management and

Budget (OMB) under the Paperwork

Reduction Act of 1995 (the PRA).

FOR FURTHER INFORMATION CONTACT:

Margaret R. Schlosburg, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–1223.

SUPPLEMENTARY INFORMATION: In the

Federal Register of September 26, 1997

(62 FR 50497), the agency announced

that the proposed information collection

had been submitted to OMB for review

and clearance under section 3507 of the

PRA (44 U.S.C. 3507). An agency may

not conduct or sponsor, and a person is

not required to respond to, a collection

of information unless it displays a

currently valid OMB control number.

OMB has now approved the information

collection and has assigned OMB

control number 0910–0352. The

approval expires on November 30, 2000.

Dated: December 23, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–075 Filed 1-2-98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D–0506]

Commercialization of In Vitro

Diagnostic Devices (IVD’s) Labeled for

Research Use Only or Investigational

Use Only; Draft Compliance Policy

Guide; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft Compliance Policy

Guide (CPG) entitled

‘‘Commercialization of In Vitro

Diagnostic Devices (IVD’s) Labeled for

Research Use Only or Investigational

Use Only.’’ The purpose of the CPG is

to provide guidance on FDA’s

enforcement priorities concerning

investigational or research IVD’s that are

being commercialized for diagnostic or

prognostic purposes.

DATES: Written comments on the draft

CPG may be submitted by April 6, 1998.

ADDRESSES: Submit written comments

on the draft CPG to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857. Submit written requests for

single copies of the draft CPG to the

Division of Small Manufacturers

Assistance (DSMA), Center for Devices

and Radiological Health (CDRH) (HFZ–

220), Food and Drug Administration,

1350 Piccard Dr., Rockville, MD 20850

(301–443–6597 or outside MD 1–800–

638–2041). Send two self-addressed

adhesive labels to assist that office in

processing your requests, or FAX your

request to 301–443–8818. Facsimiles of

the draft CPG are available from the

Division of Small Manufacturers

Assistance, CDRH. To receive the draft

CPG on your fax machine, call the

CDRH Facts-On-Demand system at 1–

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,

‘‘671,’’ followed by the pound sign, ‘‘#’’.

Follow the remaining voice prompts to

complete the request. Copies of the draft

CPG may also be downloaded to a

personal computer with access to the

World Wide Web (www). The Office of

Regulatory Affairs (ORA) and CDRH

Home Pages include the draft CPG and

may be accessed at ‘‘http://

www.fda.gov/ora’’ or ‘‘http://

www.fda.gov/cdrh’’ respectively. The

draft CPG will be available on the

Compliance References or Compliance

Information pages for ORA and CDRH

respectively.

FOR FURTHER INFORMATION CONTACT:

Betty W. Collins, Office of Compliance

(HFZ–300), Center for Devices and

Radiological Health, Food and Drug

Administration, 2098 Gaither Rd.,

Rockville, MD 20850, 301–594–4588,

ext. 165.

SUPPLEMENTARY INFORMATION: FDA has

developed a draft CPG to provide

guidance on FDA’s enforcement

priorities concerning investigational or

research IVD’s that are being

commercialized for diagnostic or

prognostic purposes. This draft CPG

applies to IVD’s sold or distributed as

test kits. Many manufacturers of IVD’s

have not followed the requirements set

forth in parts 809 and 812 (21 CFR parts

809 and 812). As a result, numerous

IVD’s labeled for research or

investigational purposes are being

promoted, distributed, and used for

commercial purposes. This has resulted

in the widespread use of laboratory tests

with unproven performance

characteristics. Unless exempted from

the requirement to submit premarket

notification under section 510(k) of the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 360b(k)), IVD’s that

are commercially distributed for

diagnostic use prior to FDA approval or

clearance are adulterated and

misbranded under sections 501(f)(1)(B)

and 502(o) of the act (21 U.S.C.

351(f)(1)(B) and 352(o)). Such

distribution subjects the devices and

responsible firms to regulatory action.

However, FDA recognizes that certain

improperly commercialized IVD’s have

been in extensive clinical use for a

significant period of time. FDA further

recognizes that immediate regulatory

action against certain IVD’s might result

in adverse consequences to individual

patients and the public health.

Therefore, FDA has prepared a draft

CPG in order to describe its enforcement

policy. Except in specified instances,

FDA does not intend to initiate

enforcement action, for 18 to 30 months

from the Federal Register publication

date of the notice of availability (NOA)

for the final CPG on commercialization

of IVD’s labeled for research use only or

investigational use only, against IVD’s

that have not been approved or cleared,

provided the IVD manufacturers,

importers, and distributors take steps

and obtain FDA approval of a premarket

approval application, product license

application, or clearance of a premarket

notification submission under section

(510(k)) of the act during that time

period. Those steps include

undertaking, by 6 months from the

Federal Register publication date of the

NOA for the final CPG, any necessary

clinical investigations or other studies

under a protocol sufficient to allow

determination of the IVD’s safety and

effectiveness. FDA believes that the 18-

to 30-month time period is a reasonable

period for gathering safety and

effectiveness data and obtaining FDA

approval or clearance. This draft CPG

applies to IVD’s that are regulated by

FDA’s CDRH and Center for Biologics

Evaluation and Research, and

supersedes FDA’s earlier draft made

public in June 1996.

This draft CPG does not cover analyte

specific reagents (ASR’s) that, as

specified under §§ 809.10(e), 809.30,

and 864.4020 (21 CFR 864.4020), are not

labeled or promoted with performance

claims, and are sold to: (1) In vitro

diagnostic manufacturers; (2) clinical

laboratories regulated under the Clinical

Laboratory Improvement Amendments

of 1988 as qualified to perform high

complexity testing under 42 CFR part

493 or clinical laboratories regulated

under the Veterans Health

Administration Directive 1106; and (3)

organizations that use the ASR to make

tests for purposes other than providing

diagnostic information to patients and

practitioners. ASR’s are defined as
236 Federal Register / Vol. 63, No. 2 / Monday, January 5, 1998 / Notices

antibodies, both polyclonal and

monoclonal, specific receptor proteins,

ligands, nucleic acid sequences, and

similar reagents which, through specific

binding or chemical reaction with

substances in a specimen, are intended

for use in a diagnostic application for

identification and quantification of an

individual chemical substance or ligand

in biological specimens. FDA’s final

rule on ASR’s was published in the

Federal Register of November 21, 1997

(62 FR 62243).

Additionally, this draft CPG does not

pertain to in vitro products whose use

is limited to laboratory research that is

entirely unrelated to the development of

IVD’s.

This draft guidance document

represents the agency’s current thinking

on commercialization of in vitro

diagnostic devices labeled for research

use only or investigational use only. 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.

Interested persons may submit to the

Dockets Management Branch (address

above) written comments on the draft

CPG entitled ‘‘Commercialization of In

Vitro Diagnostic Devices (IVD’s) Labeled

for Research Use Only or Investigational

Use Only.’’ 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 agency

will review all comments, but in issuing

a final CPG, need not specifically

address every comment. The agency

will make changes to the CPG in

response to comments, as appropriate. A

copy of the draft CPG and received

comments may be seen in the Dockets

Management Branch (address above)

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

through Friday.

Dated: December 22, 1997.

Gary Dykstra,

Acting Associate Commissioner for

Regulatory Affairs.

[FR Doc. 98–011 Filed 1-2-98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D–0525]

Draft Guidance for Industry:

‘‘Promoting Medical Products in a

Changing Healthcare Environment; I.

Medical Product Promotion by

Healthcare Organizations or Pharmacy

Benefits Management Companies

(PBMs)’’

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 ‘‘Promoting Medical

Products in a Changing Healthcare

Environment; I. Medical Product

Promotion by Healthcare Organizations

or Pharmacy Benefits Management

Companies (PBMs).’’ This document

provides guidance to sponsors of

regulated medical products (human

drugs, biologics, and medical devices)

by describing circumstances in which

sponsors may be held responsible for

promotional activities performed by

healthcare organizations or PBM’s that

violate the Federal Food, Drug, and

Cosmetic Act (the act) and regulations

issued thereunder. The intent of this

draft guidance is to provide clarification

and consistency in the agency’s

regulation of medical product

promotion in light of changes in the

healthcare environment.

DATES: Written comments may be

submitted on the draft guidance

document by April 6, 1998. General

comments on agency guidance

documents are welcome at any time.

ADDRESSES: An electronic version of this

draft guidance is available on the

Internet using the World Wide Web

(WWW) at http://www.fda.gov/cder/

guidance.htm. Submit written

comments to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 12420 Parklawn Dr., rm

1–23, Rockville, MD 20857. Submit

written requests for single copies of the

draft guidance for industry entitled

‘‘Promoting Medical Products in a

Changing Healthcare Environment; I.

Medical Product Promotion by

Healthcare Organizations or Pharmacy

Benefits Management Companies

(PBMs)’’ 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 selfaddressed adhesive label to assist that

office in processing your request.

Requests and comments should be

identified with the docket number

found in brackets in the heading of this

document. A copy of 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.

FOR FURTHER INFORMATION CONTACT:

Regarding prescription drugs: Laurie

B. Burke, Center for Drug

Evaluation and Research (HFD–40),

Food and Drug Administration,

5600 Fishers Lane, Rockville, MD

20857, 301–827–2828, or via

Internet at burkel@cder.fda.gov;

Regarding prescription biological

products: Toni M. Stifano, Center

for Biologics Evaluation and

Research (HFM–200), Food and

Drug Administration, 1401

Rockville Pike, Rockville, MD

20852–1448, 301–827–3028, or via

Internet at stifano@cber.fda.gov;

Regarding restricted medical devices:

Byron L. Tart, Center for Devices

and Radiological Health (HFZ–302),

Food and Drug Administration,

2098 Gaither Rd., Rockville, MD

20850, 301–594–4639, or via

Internet at bxt@cdrh.fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

A. FDA’s Guidance Document

Development Process

On March 28, 1997, as part of the

agency’s ongoing efforts to ensure

meaningful public participation in the

guidance document development

process, FDA’s Division of Drug

Marketing, Advertising, and

Communications (DDMAC) requested

public comment on guidance

documents relating to prescription drug

advertising and labeling (Ref. 1).

Included in the list of currently

proposed guidance documents was

‘‘Promotion to Managed Care

Organizations.’’ The draft guidance

document now being made available is

the first draft document to be issued on

this topic and addresses only one aspect

of promotion to managed care, i.e.,

promotion by healthcare organizations

or PBM’s. Other related draft guidance

documents will be issued separately

under the general heading ‘‘Promoting

Medical Products in a Changing

Healthcare Environment.’’

B. Statutory and Regulatory

Requirements

Under the act, FDA has responsibility

for regulating the labeling and, in many

cases, the advertising of medical