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

every exemption request is grossly out

of proportion to the minimal increment

in protection of the environment that

may be gained. The comment proposed

an alternative approach whereby an EA

would be required only in extraordinary

circumstances (i.e., where significant

adverse environmental impacts may

occur that are not subject to regulation

by other authorities). The comment did note that FDA had

published a proposed rule (National

Environmental Policy Act (NEPA):

Proposed Revision of Policies and

Procedures; in the Federal Register of

April 3, 1996 (61 FR 14922);

republished May 1, 1996 (61 FR 19476),

that would eliminate the requirement

for EA’s for certain types of actions

resulting from requests for exemption

from regulation as a food additive under

§ 170.39 and that would also eliminate

the requirement for information on

possible environmental effects at the

sites of manufacture of all FDAregulated substances. This comment,

submitted by a trade association, noted

that the association also submitted a

comment to the agency on the proposed

NEPA rule. The association’s comment

on the proposed NEPA rule is

essentially identical to the present

comment outlined in the preceding

paragraph. In the Federal Register of July 29,

1997 (62 FR 40570), the agency

published a final rule revising its NEPA

policies and procedures (‘‘the final

NEPA rule’’). The final NEPA rule was

issued after the agency reviewed and

addressed the comments received on its

April 3, 1996, proposed rule, including

the comment submitted by the trade

association, summarized previously. As discussed in detail in the preamble

to the final NEPA rule (62 FR 40579

through 40581), the agency agreed in

part with the comment and expanded

the scope of actions included in two

categorical exclusions § 25.32(i) and (j)

(21 CFR 25.32(i) and (j)), including

actions on requests for exemption from

regulation under § 170.39. However, as

further discussed in the preamble to the

final NEPA rule, the agency did not

agree completely with this comment.

Specifically, FDA concluded that

certain classes of actions on foodcontact materials should continue to

require EA’s and that the preparation of

EA’s for requests for these actions is not

unduly burdensome for the industry.

The § 170.39 exemption requests that

continue to require an EA are, for the

most part, for actions on substances

present at greater than 5 percent of

finished food-packaging materials that

are not components of coatings and for

actions on substances present at 5

percent or less of finished foodpackaging materials that are not

expected to remain with finished foodpackaging materials through use by

consumers. As the agency explained in

the preamble to the final NEPA rule,

actions on these types of substances

have the potential for significant

environmental impact, and such

potential can be evaluated only by the

agency’s review of EA’s prepared by

requesters. In accordance with 21 CFR

25.21, EA’s are also required for those

actions where extraordinary

circumstances indicate that there may

be significant environmental effects,

even though the actions belong to a

class that ordinarily would warrant

exclusion from the requirement to

prepare an EA. Guidance on preparing

EA’s is available from the Food and

Drug Administration’s Office of

Premarket Approval (HFS–200), 200 C

St. SW., Washington, DC 20204.

In addition to the review summarized

previously that resulted in the agency

expanding the scope of two categorical

exclusions (§ 25.32(i) and (j)), the

agency has also reviewed the types of

uses of food-contact articles that have

been the subject of exemption requests

received since the threshold of

regulation process was implemented on

August 16, 1995. The agency estimates

that the percentage of uses that will

qualify for categorical exclusion under

the agency’s revised NEPA regulations

may be as high as 8 percent. It is further

estimated that those exemption requests

that qualify for categorical exclusions

will require, on average, 48 h to prepare

as opposed to the 88 h typically

required to prepare exemption requests

that include an EA. This would

represent a 45 percent reduction in

paperwork burden for such requests.

The overall paperwork burden

associated with the threshold of

regulation process would also decrease

dramatically. Prior to implementation of

the amended NEPA regulations, the

annual industry burden associated with

threshold of regulation exemption

requests was estimated to be 5,280 h

based on the assumption that the agency

receives 60 requests per year and that

each request requires on average 88 h to

prepare. If, as projected, 87 percent of

threshold of regulation exemption

requests qualify for the categorical

exclusions discussed previously, it is

estimated that the overall paperwork

burden would decrease to 3,200 h (52

requests x 48 h + 8 requests x 88 h). This

would represent a 39 percent overall

reduction in paperwork burden.

2. One comment asserted that the

requirement that a manufacturer of a

substance submit an exemption from

regulation request to FDA is not

necessary for the proper performance of

FDA’s functions. Instead, the comment

argued that manufacturers should be

able to make their own determination as

to whether the use of a substance in a

food contact article meets the criteria for

exemption set out in § 170.39. The

comment further asserted that allowing

self-determinations of exemption status

would substantially reduce the burden

on industry.

FDA disagrees with this comment for

several reasons. In the preamble to the

final rule issuing § 170.39, the agency

responded in detail to comments

recommending that manufacturers be

permitted to determine themselves

whether use of a substance is entitled to

an exemption from the food additive

listing regulation requirement (60 FR

36582 at 36586 through 36587. In that

response, the agency explained that

under Monsanto v. Kennedy, 613 F. 2d

947 (D.C. Cir. 1979), only the

Commissioner of Food and Drugs has

the authority to exempt a substance

from regulation as a food additive. The

agency’s response also discussed in

detail the policy rationale underlying

the procedure in § 170.39 (i.e., that a

process wherein the agency determines

which substances will be exempt from

regulation as food additives will be

binding on the agency and will ensure

more consistent exemption decisions).

For the same reasons discussed in the

preamble to the final rule, FDA

concludes that this comment does not

provide a basis for altering the

information collection requirements of

§ 170.39.

Dated: December 24, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–086 Filed 1-2-98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 95N–0374]

Agency Information Collection

Activities; Announcement of OMB

Approval

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Latex Condoms; User Labeling;

Expiration Dating’’ has been approved
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