Federal Register / Vol. 65, No. 111 / Thursday, June 8, 2000 / Rules and Regulations 36319

(2) For the purposes of these mandatory

inspections, piece-part opportunity means:

(i) The part is completely disassembled

when done in accordance with the

disassembly instructions in the engine

manufacturer’s Heavy Maintenance Manual;

and

(ii) The part has accumulated more than

100 cycles in service since the last piece-part

opportunity inspection, provided that the

part was not damaged or related to the cause

for its removal from the engine.’’

(b) Except as provided in paragraph (c) of

this AD, and notwithstanding contrary

provisions in § 43.16 of the Federal Aviation

Regulations (14 CFR 43.16), these mandatory

inspections shall be performed only in

accordance with the Airworthiness

Limitations Section of the Allison Engine

Company AE 3007A and AE 3007C Engine

Manuals.

Alternative Methods of Compliance

(c) An alternative method of compliance or

adjustment of the compliance time that

provides an acceptable level of safety may be

used if approved by the Engine Certification

Office (ECO). Operators shall submit their

requests through an appropriate FAA

Principal Maintenance Inspector (PMI), who

may add comments and then send it to the

ECO.

Note 2: Information concerning the

existence of approved alternative methods of

compliance with this airworthiness directive,

if any, may be obtained from the ECO.

Ferry Flights

(d) Special flight permits may be issued in

accordance with §§ 21.197 and 21.199 of the

Federal Aviation Regulations (14 CFR 21.197

and 21.199) to operate the airplane to a

location where the requirements of this AD

can be accomplished.

Continuous Airworthiness Maintenance

Program

(e) FAA-certificated air carriers that have

an approved continuous airworthiness

maintenance program in accordance with the

record keeping requirement of § 121.369 (c)

of the Federal Aviation Regulations (14 CFR

121.369 (c)) must maintain records of the

mandatory inspections that result from

revising the Airworthiness Limitations

Section and the air carrier’s continuous

airworthiness program. Alternately,

certificated air carriers may establish an

approved system of record retention that

provides a method for preservation and

retrieval of the maintenance records that

include the inspections resulting from this

AD and include the policy and procedures

for implementing this alternate method in the

air carrier’s maintenance manual required by

§ 121.369 (c) of the Federal Aviation

Regulations (14 CFR 121.369 (c)). However,

the alternate system must be accepted by the

appropriate PMI and require the maintenance

records be maintained either indefinitely or

until the work is repeated. Records of the

piece-part inspections are not required under

§ 121.380 (a) (2) (vi) of the Federal Aviation

Regulations (14 CFR 121.380 (a) (2) (vi)). All

other operators must maintain the records of

mandatory inspections required by the

applicable regulations governing their

operations.

Note 3: The requirements of this AD have

been met when the engine manual changes

are made and air carriers have modified their

continuous airworthiness maintenance plans

to reflect the requirements in the engine

manuals.

Effective Date

(f) This amendment becomes effective on

August 7, 2000.

Issued in Burlington, Massachusetts, on

June 2, 2000.

David A. Downey,

Assistant Manager, Engine and Propeller

Directorate, Aircraft Certification Service.

[FR Doc. 00–14441 Filed 6–7–00; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 310, 352, and 700

[Docket No. 78N–0038]

RIN 0910–AA01

Sunscreen Drug Products for Over-theCounter Human Use; Final Monograph;

Extension of Effective Date; Reopening

of Administrative Record

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; extension of effective

date; reopening of administrative

record.

SUMMARY: The Food and Drug

Administration (FDA) is extending to

December 31, 2002, the effective date for

the final monograph for over-thecounter (OTC) sunscreen drug products

that published in the Federal Register of

May 21, 1999 (64 FR 27666). The final

monograph established conditions

under which OTC sunscreen drug

products are generally recognized as

safe and effective and not misbranded.

The extension of the effective date

applies to all OTC sunscreen drug

products that would be regulated under

parts 310, 352, and 700 (21 CFR parts

310, 352, and 700). In addition, FDA is

reopening the administrative record for

the rulemaking for OTC sunscreen drug

products to allow for comment

specifically on the information

requested in this document. FDA is

taking this action in response to a

citizen petition requesting that the

agency, among other things, initiate an

administrative process to publish a

‘‘comprehensive’’ sunscreen final

monograph that addresses formulation,

labeling, and testing requirements for

both ultraviolet B (UVB) and ultraviolet

A (UVA) radiation protection.

DATES: Effective date: The effective date

of the amendments to parts 310, 352,

and 700 in the regulation published at

64 FR 27666, May 21, 1999, is delayed

until December 31, 2002. The

amendment in this final rule to

§ 310.545 is effective December 31,

2002.

Compliance dates: For products with

annual sales less than $25,000

compliance is December 31, 2003. For

all other OTC drug products compliance

is December 31, 2002.

Comment date: Submit written

comments by September 6, 2000. The

administrative record will remain open

until September 6, 2000.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Donald Dobbs, Center for Drug

Evaluation and Research (HFD–560),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–2222.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of May 12,

1993 (58 FR 28194), the agency

published a notice of proposed

rulemaking in the form of a tentative

final monograph (TFM) for OTC

sunscreen drug products. The TFM

proposed the conditions under which

sunscreen drug products would be

considered generally recognized as safe

and effective, under section 201(p) of

the Federal Food, Drug, and Cosmetic

Act (the act) (21 U.S.C. 321(p)), and not

misbranded under section 502 of the act

(21 U.S.C. 352).

The TFM proposed labeling for

products that claim to protect against

UVB radiation and discussed the types

of labeling claims that could be used for

products that contain UVA-absorbing

ingredients. The TFM included a list of

proposed sunscreen active ingredients,

including ingredients that were believed

to have absorption spectra extending

into the UVA range.

The TFM proposed a set of testing

procedures for measuring a product’s

sun protection factor (SPF). The SPF

value measures the performance of

sunscreens that absorb erythemacausing UV radiation, but does not fully

describe a product’s UVA protection. As

the agency acknowledged in the TFM,

‘‘currently there is no generally

acceptable method for determining a

36320 Federal Register / Vol. 65, No. 111 / Thursday, June 8, 2000 / Rules and Regulations

meaningful UVA protection factor that

is analogous to the SPF’’ (58 FR 28194

at 28249).

Following publication of the TFM, the

agency continued to work closely with

interested parties to develop

standardized UVA testing procedures

and an accurate, helpful way to present

information about UVA protection in

product labeling. The agency held a

public meeting, on May 12, 1994, to

discuss UVA testing procedures. The

agency also reopened the administrative

record to allow additional submissions

on UVA-related issues until July 31,

1994 (59 FR 16042, April 5, 1994).

In the Federal Register of September

16, 1996 (61 FR 48645) and October 22,

1998 (63 FR 56584), the agency

amended the TFM to add the UVAabsorbing sunscreen ingredients

avobenzone and zinc oxide to the

proposed list of monograph ingredients.

The agency proposed indications for

these ingredients, such as ‘‘provides

broad spectrum protection’’ and

‘‘provides protection from the UVA rays

that may contribute to skin damage and

premature aging of the skin’’ (61 FR

48645 at 48655 and 63 FR 56584 at

56589).

On November 21, 1997, Congress

enacted the Food and Drug

Administration Modernization Act of

1997 (FDAMA). FDAMA section 129

provided as follows:

Not later than 18 months after the

date of enactment of this Act, the

Secretary of Health and Human Services

shall issue regulations for over-thecounter sunscreen products for the

prevention or treatment of sunburn.

Section 129 of FDAMA prompted

FDA to identify those parts of the TFM

for OTC sunscreen drug products that

could be finalized within the timeframe

set by FDAMA. In late 1997, FDA was

still working on the development of

testing standards and labeling for UVA

radiation protection. As recently as

January 27, 1999, the agency held a

public meeting to continue developing

UVA testing methods and labeling (Ref.

1). Given these outstanding issues, the

agency decided to address the FDAMA

deadline by finalizing the UVB portions

of the monograph (and related

provisions on water resistant test

methods and cosmetic labeling).

In the Federal Register of May 21,

1999 (64 FR 27666), FDA published a

final rule in the form of a final

monograph for OTC sunscreen drug

products. The monograph included 16

active ingredients, required labeling for

products that contain one or more of

these active ingredients, a standardized

test for measuring SPF values, and

standard methods for measuring the

water resistant properties of sunscreens.

The monograph included modifications

to the agency’s general OTC drug

product labeling rule in § 201.66 (21

CFR 201.66) to accommodate certain

sunscreen drug products that are

packaged in small containers, are

intended to be applied to limited areas

of the face, and otherwise meet the

factors discussed in the OTC drug

product labeling rule for monographspecific modifications (64 FR 27666 at

27681 to 27682 and 64 FR 13254 at

13270). The monograph did not,

however, address active ingredients,

labeling, and test methods for products

intended to provide UVA protection.

The agency set a 2-year effective date

(May 21, 2001) for part 352 and the

related nonmonograph conditions in

§ 310.545(a)(29). The agency also set a 2-

year effective date for new § 700.35,

which addresses cosmetic products that

contain sunscreen active ingredients for

nontherapeutic, nonphysiologic uses

(e.g., as a color additive or to protect the

color of the product). The agency set a

1-year effective date (May 22, 2000) for

new § 740.19 (21 CFR 740.19), which

addresses a warning statement for

cosmetic suntanning preparations that

do not contain a sunscreen active

ingredient. The extension of the

effective date in this document does not

apply to § 740.19.

II. Citizen Petition

Prior to publication of the sunscreen

final rule, a citizen petition (Ref. 2)

requested the agency, among other

things, to initiate an administrative

process for publishing a

‘‘comprehensive’’ sunscreen final

monograph that addresses formulation,

labeling, and testing for both UVB and

UVA radiation protection.

On July 22, 1999, the agency held a

public meeting to hear the views of

interested parties regarding the

sunscreen final monograph (Ref. 3). At

the meeting, the petitioner requested

that FDA defer the effective date of the

final rule until 2 years after it completes

a comprehensive final monograph that

includes UVA radiation protection.

After several subsequent meetings with

the agency (Ref. 4), the petitioner

proposed that a 19-month extension of

the effective date of the sunscreen final

monograph would be sufficient time for

it to submit the appropriate data to

assist FDA in completing a

comprehensive final monograph in time

for a target December 2002 effective

date.

FDA granted the petition in part by

agreeing to extend the effective date of

the monograph to December 31, 2002,

with the expectation that appropriate

data would be received within a

reasonable timeframe so that a

comprehensive UVA–UVB monograph

could be issued in advance of that date.

Accordingly, the agency is issuing this

document to extend the effective date of

the sunscreen final monograph for the

reasons set forth in its October 1, 1999,

response to the citizen petition (Ref. 5).

Copies of the petition and the agency’s

response are on file in the Dockets

Management Branch (address above)

and are available through a freedom of

information request.

III. Process for Completion of a

Comprehensive Final Monograph

The agency has requested at public

meetings on January 27, July 22, and

October 26, 1999 (Refs. 1, 3, and 6,

respectively), and in letters of July 16,

and September 2, 1999, and March 20,

2000, to the petitioner (Refs. 7, 8, and

9, respectively), the type of specific data

and information that would be helpful

for the completion of a comprehensive

final monograph for OTC sunscreen

drug products. These data and

information concerned: (1) Testing and

labeling of high SPF products, (2)

testing and labeling for UVA radiation

protection and, (3) integration of UVA

and UVB indications for use and

performance statements. To date, the

agency has received only a portion of

this requested information (Ref. 9). As

part of this reopening of the

administrative record, the agency is

including the above information and

any other information submitted to the

sunscreen docket related to the

completion of a comprehensive UVA–

UVB final monograph.

In order to complete a comprehensive

final monograph by the target December

31, 2002, effective date, the agency

intends to move forward and publish a

proposed rule for a comprehensive final

monograph, receive comments on that

proposal, and issue a final rule by

December 31, 2001. That final rule

would then have a 1-year effective date

of December 31, 2002. Therefore, in

order not to delay this process, the

agency has determined that all data and

information to be considered for the

proposed rule must be received by the

close of the administrative record as

stated in this document. After the

administrative record closes on

September 6, 2000, the agency will use

the information in the administrative

record to prepare a proposed rule for a

comprehensive final monograph for

OTC sunscreen drug products. The

agency has determined that 90 days

provides industry with a reasonable

amount of time to prepare and submit

the data requested in this document.

Federal Register / Vol. 65, No. 111 / Thursday, June 8, 2000 / Rules and Regulations 36321

IV. Request for Comment

The agency stated in the sunscreen

final rule that SPF values above 30 are

not supported at this time and that

sunscreen drug products with SPF

values above 30 should be limited to

one collective term, i.e., SPF 30 ‘‘plus’’

or ‘‘+’’ (64 FR 27666 at 27675). While

the agency believes that the sunscreen

final monograph test procedures for

measuring SPF values up to 30

represent a straightforward, wellunderstood, and sound method for

measuring these values, a number of

comments submitted in response to the

May 12, 1993, tentative final monograph

for OTC sunscreen drug products (58 FR

28194) questioned the ability of current

testing methods to accurately and

reproducibly determine SPF values for

high SPF (i.e., above SPF 30) sunscreen

drug products (64 FR 27666 at 27680).

Most of the comments’ concerns

related to potential interlaboratory

variation when utilizing SPF test

methodology. Primary concerns

included the potential for

overestimation of high SPF values due

to the spectra of currently used solar

simulators and the need for one or more

high SPF standard sunscreens (i.e., as

laboratory controls). Long radiation

exposures necessitated by SPF values

well above 30 and the use of a relatively

low SPF laboratory control may

significantly increase the potential for

decreased interlaboratory accuracy and

reproducibility for high SPF sunscreen

drug products. The agency invited

interested persons to continue

developing the test methods needed to

measure high SPF values and to provide

FDA data to support such methods. The

agency is currently evaluating data and

information subsequently received from

two comments (Refs. 10 and 11)

concerning this issue.

In the final rule, the agency discussed

the difficulty in explaining the

nonlinearity (i.e., percent reduction in

erythemogenic UV radiation) of the SPF

rating system in the limited space on a

product label (64 FR 27666 at 27675).

The agency also invited interested

persons to consider proposed methods

for communicating in labeling the level

of protection associated with high SPF

values. To date, the agency has not

received any proposals relative to the

labeling of sunscreens with high SPF

values.

After review of the comments

concerning the adequacy of current

testing procedures for determining high

SPF numbers, the agency has identified

eight areas in which it seeks additional

data and information. The agency is

requesting further comment in these

areas to provide interested parties the

opportunity to submit data and

information to address these issues. It is

not necessary to resubmit data and

information previously provided to the

agency. A cross-reference to an earlier

submission will be sufficient.

A. Solar Simulator Spectral Power

Distribution

The agency has received several

comments, including a recent citizen

petition (Ref. 10), suggesting the

adoption of a spectral power

distribution that specifies the

proportion of erythema-effective

radiation in a table format. The

comments suggested that the spectra of

currently used solar simulators

(especially around 290 nanometers (nm)

and above 350 nm) could cause

overestimation of SPF values for high

SPF sunscreens. Because shorter

wavelengths can make a very large

contribution to erythema, the comments

stated that small errors in the 290 nm

region of solar simulator spectra could

have considerable effects. In addition,

the comments noted that spectral power

deficiencies above 350 nm may give

artificially high SPF values for

sunscreen drug products that absorb

poorly in the long wavelength UVA

region. The comments suggested that

the agency replace the specifications in

§ 352.71 of the sunscreen monograph

that state ‘‘sun at a zenith angle of 101⁄2’’

and ‘‘less than 1 percent shorter than

290 nm’’ with the European Cosmetic,

Toiletry, and Perfumery Association

(COLIPA) table of ‘‘percent erythemal

contribution’’ (Ref. 10) as the spectral

power distribution standard for the light

source used in the SPF test procedures.

The agency is requesting comment on

whether the solar simulator spectral

distribution specifications contained in

the COLIPA standard are appropriate for

use in SPF testing procedures. The

agency would also like comment on a

potential modification of the standard

that would modify the erythemaeffective radiation contribution of

wavelengths below 290 nm to less than

0.1 percent (to prevent overestimation of

SPF values). The agency believes that

this specification is readily obtainable

with commercially available cut-off

filters. In addition, the agency is

interested in comment concerning the

practicality of lowering the below-290

nm specification to 0.01 percent.

Therefore, a solar simulator using the

following modification of the COLIPA

standard for determining the SPF of a

sunscreen drug product would be

filtered so that it provides a continuous

emission spectrum from 290 to 400 nm

with the following percentage of

erythema-effective radiation in each

specified range of wavelengths:

TABLE 1.—SOLAR SIMULATOR EMISSION SPECTRUM

Wavelength Range (nm) Percent Erythemal Contribution

< 290 < 0.1

290–310 46.0–67.0

290–320 80.0–91.0

290–330 86.5–95.0

290–340 90.5–97.0

290–350 93.5–99.0

B. Thermal Overloading of the Skin

The testing of high SPF sunscreen

drug products necessitates longer

exposure times than testing of lower

SPF values. Such increases in irradiance

levels have the potential to produce

thermal overloading of the skin and

influence the UV radiation dose

reciprocity relationship (and therefore

SPF values). The comments suggested

that limits such as 1,250 to 1,500 watts/

meter2 be placed on the total irradiance

delivered to the skin for all

wavelengths. Several comments,

including a recent citizen petition (Ref.

10), also suggested that the ‘‘out of

band’’ specification in § 352.71 of the

sunscreen monograph (i.e., that not

more than 5 percent of a solar

simulator’s total energy output can be

contributed by wavelengths longer than

400 nm) is not obtainable from many

devices currently utilized for evaluating

sunscreens.

The agency considers it important to

limit total energy delivered to the skin

36322 Federal Register / Vol. 65, No. 111 / Thursday, June 8, 2000 / Rules and Regulations

so that skin temperature does not reach

a point that influences the UV dose

reciprocity relationship when

encountering the long exposure times

necessary to test high SPF sunscreen

drug products. The agency is requesting

comment on whether replacing the ‘‘out

of band’’ specifications in § 352.71 with

a limit on total solar simulator

irradiance for all wavelengths may be an

appropriate modification of current

testing procedures that will improve the

testing of high SPF sunscreens. In

addition, the agency is also requesting

comment on an appropriate irradiance

limit for this modification.

C. High SPF Standard Sunscreen

The agency received several

comments suggesting that standard

sunscreens (i.e., controls) with SPF

values of 15 or higher be developed for

testing high SPF sunscreen drug

products. Studies submitted by the

comments tend to support the

conclusion that a specific control(s) may

be needed to accurately test high SPF

sunscreen drug products. However,

these studies lacked sufficient numbers

of subjects, did not address suitability of

a standard across different laboratories,

and did not document the following

properties required in a standard

sunscreen: (1) Low level of

interlaboratory variation, (2) sensitivity

to experimental error, and (3) ease of

preparation with a reasonable degree of

accuracy.

One comment supplied ‘‘roundrobin,’’ collaborative SPF testing data

from 7 laboratories on 153 subjects, with

2 possible SPF 15 standard sunscreens,

‘‘Formulation A’’ and ‘‘Formulation B’’

(Refs. 12 and 13). The agency believes

that the data could support

‘‘Formulation B’’ as an appropriate SPF

15 standard sunscreen if additional

information is submitted and found

acceptable. Because the formulation was

supplied to all laboratories by a single

source, there are no data to demonstrate

that multiple laboratories can prepare,

assay, and utilize the standard

successfully. Further, the standards

were not analyzed by the

spectrophotometric method in

§ 352.70(c) of the sunscreen monograph,

but rather by an alternate proposed

method (see section IV.D of this

document). The agency is requesting the

submission of the additional data

necessary to document the suitability of

Formulation ‘‘B’’ and the analytical

method.

In addition, the agency is requesting

comment and any supporting data and

information concerning the need for

additional standard sunscreens (with

SPF values higher than 15) as well as

the use of specific standard sunscreens

for specific ranges of SPF values (i.e.,

bracketing).

D. High-Performance Liquid

Chromatography (HPLC) Assay

As discussed in section IV.C of this

document, data supplied in support of

an SPF 15 standard sunscreen

preparation included the use of an

HPLC assay instead of the

spectrophotometric assay in § 352.70(c).

The comment suggested that the HPLC

protocol is now commonly used by

analytical laboratories for the assay of

sunscreen formulations (and that it can

also be used for the homosalate standard

sunscreen). The agency invites specific

comment and data from analytical

laboratories as to which assay method

they use and why they use that

particular method.

Before the agency can evaluate the

HPLC method supplied with the SPF 15

standard sunscreen data, method

validation data are necessary. The

agency is requesting a validation

package that documents specificity,

accuracy, limit of detection, linearity,

precision, and reproducibility of the

method. The agency is especially

concerned that the presence of any

impurities (particularly UV radiationabsorbing impurities) in the standard

sunscreen and product formulations can

be detected by the HPLC method,

because interfering substances could

affect the SPF determination. The

validation package should include

chromatograms and demonstrate that

the HPLC method is suitable for both

the SPF 4 (homosalate) and SPF 15

standards (or other standard sunscreens,

if appropriate). The chemistry guideline

entitled ‘‘Reviewer Guidance,

Validation of Chromatographic

Methods’’ explains these requirements

in greater detail and is available on the

agency’s Internet website for the Center

for Drug Evaluation and Research

(CDER) (http://www.fda.gov/cder/

guidance/index.htm), or may be

obtained from the Drug Information

Branch (HFD–211), CDER, Food and

Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–827–

4573.

E. Number of Test Subjects

Several comments suggested that the

‘‘limitation’’ of 20 to 25 subjects in the

SPF test in § 352.72(g) may be an issue

for sunscreen drug products with high

SPF values due to potential for high

variability in the responses obtained.

The comments indicated that more than

20 to 25 subjects may be necessary. The

agency is requesting data and

information on the testing of SPF values

over 30 in relation to this issue and

suggestions for an appropriate number

of test subjects to be used in such

testing.

F. Exposure Doses

Determination of the minimal

erythemal dose on protected skin

(MED(PS)) is described in § 352.73(c) of

the SPF testing procedures as follows:

* * * A series of seven exposures

shall be administered to the protected

test sites to determine the MED of the

protected skin (MED(PS)). The doses

selected shall consist of a geometric

series of five exposures, where the

middle exposure is placed to yield the

expected SPF plus two other exposures

placed symmetrically around the

middle exposure. * * *

The agency proposed this format in

the tentative final monograph (58 FR

28194 at 28269 to 28272), in the context

of SPF values up to 30, because of its

concern that a widely-spaced geometric

progression offers less accuracy and

precision in the upper SPF ranges and

may produce overestimation of the true

SPF. Exposure dose intervals in the

above geometric series decrease as

expected SPF values increase.

The agency is requesting comment

and any supporting data and

information concerning the adequacy of

the current exposure dose format in the

testing of sunscreen drug products

claiming to have SPF values over 30.

G. Labeling

In the sunscreen final rule (64 FR

27666 at 27675), the agency stated that

the nonlinearity (i.e., percent reduction

in erythemogenic UV radiation) of the

SPF rating system is a concept difficult

to explain in the limited space on a

product label. The agency noted the

relatively small difference in additional

sunburn protection for most people

provided by SPF 30 and SPF 50

sunscreens in terms of their absorption

of erythemal UV radiation. The agency

has a continuing concern about

consumers’ perception and

understanding of the difference in

screening abilities between, for

example, an SPF 4 and SPF 15 as

opposed to an SPF 30 and SPF 50.

The agency is concerned that an

average sunscreen consumer may

ascribe more to high SPF values than is

clinically relevant and that such

products may further encourage the use

of sunscreens as a safe way to prolong

sun exposure. The concept of increasing

SPF values has been described in the

context of increasing the time for which

a person could be exposed to the sun

without burning. While such a

description may be true, it omits

Federal Register / Vol. 65, No. 111 / Thursday, June 8, 2000 / Rules and Regulations 36323

essential information about skin cancers

and photoaging that may occur from

different (i.e., nonerythemogenic)

wavelengths and/or at suberythemal

doses of UV radiation in the

erythemogenic wavelength region.

Sunscreen use alone will not prevent all

of the possible harmful effects of the sun

for all consumers, even with the use of

high SPF sunscreen drug products.

Variation between individuals, UV

radiation absorption and substantivity

of sunscreen drug products, exposure

conditions, and conditions of use (e.g.,

inadequate application/reapplication)

preclude a precise result for each

individual. Sunscreens are part of a sun

protection program in which it is clear

that the goal is to limit sun exposure

even with the use of a sunscreen.

Without adequate labeling, high SPF

numbers may dilute the desired public

health message. In addition, previously

submitted labeling comprehension data,

which were discussed at a public

meeting (Ref. 14), indicated a fair

amount of confusion concerning

consumer comprehension of the SPF

rating system.

The agency is requesting comment on

any proposed methods for meaningfully

communicating in product labeling the

level of sun protection associated with

high SPF sunscreen drug products. In

addition to this information, the agency

is also requesting comment relative to

the use of professional labeling (and

what that labeling might state)

specifically to provide high SPF value

information to health professionals.

H. Technical and Human Limitations

The agency is aware that the testing

of sunscreen drug products with high

SPF values necessitates the use of longer

ultraviolet radiation exposure times.

Such exposures can result in test

subjects remaining in front of the light

source for several hours, especially

when a standard sunscreen and water

resistance test are also included (Ref.

11).

Considering the generally available

SPF test equipment currently used in

testing laboratories, the agency is

requesting comment on the practical

human limitations of the test relative to

high SPF values. Is the determination of

an SPF value routinely practicable for

SPF values of, for example, 60 or

higher? What total exposure times

would be involved at such SPF levels?

What is the practical limit in terms of

the SPF value?

V. Comment on the Extension of the

Effective Date

In its October 1, 1999, citizen petition

response (Ref. 5), the agency set forth in

detail its finding that a stay of the

effective date for the sunscreen final

monograph, until December 31, 2002,

would be in the public interest. Since

the agency is extending the effective

date of the sunscreen final monograph

based on the citizen petition response,

it finds, for good cause, that this

extension of the effective date of the

final monograph does not require

further notice and comment procedures

(5 U.S.C. 553(b)). More than 6 months

have passed since the agency issued the

petition response and the agency has

received no adverse correspondence or

comments with respect to its decision.

Therefore, the agency is now extending

the effective date of the final rule.

However, in accordance with 21 CFR

10.40(e)(1), the agency will accept

comment on this extension for a period

of 90 days.

VI. Analysis of Impacts

The economic impact of the final

monograph was discussed in the final

rule (64 FR 27666 at 27683). This

extension of the effective date provides

additional time for companies to relabel,

retest, and reformulate affected products

and will reduce label obsolescence, as

there will be additional time to use up

more existing labeling. This extension

will also eliminate a second relabeling

of sunscreen drug products when UVA

labeling is included in the monograph.

Thus, extending the effective date of the

final rule until December 31, 2002, and

the compliance date for products with

annual sales less than $25,000 to

December 31, 2003, will significantly

reduce the economic impact on

industry.

FDA has examined the impacts of this

final rule under Executive Order 12866,

the Regulatory Flexibility Act (5 U.S.C.

601–612), and the Unfunded Mandates

Reform Act of 1995 (2 U.S.C. 1501 et

seq.). Executive Order 12866 directs

agencies to assess all costs and benefits

of available regulatory alternatives and,

when regulation is necessary, to select

regulatory approaches that maximize

net benefits (including potential

economic, environmental, public health

and safety, and other advantages;

distributive impacts; and equity). Under

the Regulatory Flexibility Act, if a rule

has a significant economic impact on a

substantial number of small entities, an

agency must analyze regulatory options

that would minimize any significant

impact of the rule on small entities.

Section 202(a) of the Unfunded

Mandates Reform Act requires that

agencies prepare a written statement

and economic analysis before proposing

any rule that may result in an

expenditure in any one year by State,

local, and tribal governments, in the

aggregate, or by the private sector, of

$100 million (adjusted annually for

inflation).

The purpose of the final rule is to

reopen the administrative record and to

extend the effective date which will

provide manufacturers additional time

to use up existing product labeling. The

agency believes that this final rule is

consistent with the regulatory

philosophy and principles identified in

the Executive Order. In addition, the

final rule is not a significant regulatory

action as defined by the Executive Order

and so is not subject to review under the

Executive Order.

Under the Unfunded Mandates

Reform Act, FDA is not required to

prepare a statement of costs and benefits

for this final rule because this final rule

is not expected to result in any one-year

expenditure that would exceed $100

million adjusted for inflation.

The agency also certifies that this

final rule will not have a significant

economic impact on a substantial

number of small entities. Therefore,

under the Regulatory Flexibility Act, no

further analysis is required.

VII. Environmental Impact

The agency has determined under 21

CFR 25.31(a) that this action is of a type

that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

VIII. References

The following references are on

display in Docket No. 78N–0038 in the

Dockets Management Branch (address

above) and may be seen by interested

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

Monday through Friday.

1. Comment No. MM16.

2. Comment No. CP11.

3. Comment No. MM21.

4. Comment No. MM17, MM18, and

MM19.

5. Comment No. PAV2.

6. Comment No. MM22.

7. Comment No. LET168.

8. Comment No. ANS6.

9. Comment No. Let170

10. Comment No. CP12.

11. Comment No. C557

12. Comment No. C111 and RPT7.

13. Letter from T. J. Donegan, The

Cosmetic, Toiletry, and Fragrance

Association, to J. D. Lipnicki, FDA, in

OTC Vol. 06FREXT.

14. Comment No. MM14.

List of Subjects in 21 CFR Part 310

Administrative practice and

procedures, Drugs, Labeling, Medical

36324 Federal Register / Vol. 65, No. 111 / Thursday, June 8, 2000 / Rules and Regulations

devices, Reporting and recordkeeping

requirements.

Therefore, under the Federal Food,

Drug, and Cosmetic Act, and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 310 is

amended as follows:

PART 310—NEW DRUGS

1. The authority citation for 21 CFR

part 310 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352,

353, 355, 360b-360f, 360j, 361(a), 371, 374,

375, 379e; 42 U.S.C. 216, 241, 242(a), 262,

263b-263n.

2. Section 310.545 is amended by

revising paragraph (d)(31) to read as

follows:

§ 310.545 Drug products containing

certain active ingredients offered over-thecounter (OTC) for certain uses.

* * * * *

(d) * * *

(31) December 31, 2002, for products

subject to paragraph (a)(29) of this

section.

Dated: May 30, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–14212 Filed 6–7–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 880

[Docket No. 98N–0786]

General Hospital and Personal Use

Devices; Classification of Liquid

Chemical Sterilants/High Level

Disinfectants and General Purpose

Disinfectants

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is classifying

liquid chemical sterilants/high level

disinfectants intended for use as the

terminal step in processing critical and

semicritical medical devices prior to

patient use into class II (special

controls), and general purpose

disinfectants intended to process

noncritical medical devices and

equipment surfaces into class I (general

controls). FDA is also exempting the

general purpose disinfectants from the

premarket notification requirements.

This action is being taken under the

Federal Food, Drug, and Cosmetic Act

(the act), as amended by the Medical

Device Amendments of 1976 (the 1976

amendments), the Safe Medical Devices

Act of 1990 (the SMDA), and the Food

and Drug Administration Modernization

Act of 1997 (the FDAMA).

DATES: This rule is effective July 10,

2000.

FOR FURTHER INFORMATION CONTACT:

Chiu S. Lin, Center for Devices and

Radiological Health (CDRH) (HFZ–480),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–443–8913.

SUPPLEMENTARY INFORMATION:

I. Background

The act (21 U.S.C. 301 et seq.), as

amended by the 1976 amendments

(Public Law 94–295), the SMDA (Public

Law 101–629), and the FDAMA (Public

Law 105–115), established a

comprehensive system for the regulation

of medical devices intended for human

use. Section 513 of the act (21 U.S.C.

360c) established three categories

(classes) of devices, depending on the

regulatory controls needed to provide

reasonable assurance of their safety and

effectiveness. The three categories of

devices are class I (general controls),

class II (special controls), and class III

(premarket approval).

Under section 513 of the act, devices

that were in commercial distribution

before May 28, 1976 (the date of

enactment of the 1976 amendments),

generally referred to as preamendments

devices, are classified after FDA has: (1)

Received a recommendation from a

device classification panel (an FDA

advisory committee); (2) published the

panel’s recommendation for comment,

along with a proposed regulation

classifying the device; and (3) published

a final regulation classifying the device.

FDA has classified most

preamendments devices under these

procedures.

Devices that were not in commercial

distribution prior to May 28, 1976,

generally referred to as postamendments

devices, are classified automatically by

statute (section 513(f) of the act (21

U.S.C. 360c(f))) into class III without

any FDA rulemaking process. Those

devices remain in class III and require

premarket approval, unless and until:

(1) The device is reclassified into class

I or II; (2) FDA issues an order

classifying the device into class I or II

in accordance with new section

513(f)(2) of the act, as amended by the

FDAMA; or (3) FDA issues an order

finding the device to be substantially

equivalent, in accordance with section

513(i) of the act, to a predicate device

that does not require premarket

approval. The agency determines

whether new devices are substantially

equivalent to previously offered devices

by means of premarket notification

procedures in section 510(k) of the act

(21 U.S.C. 360(k)) and 21 CFR part 807

of the regulations.

A preamendments device that has

been classified into class III may be

marketed, by means of premarket

notification procedures, without

submission of a premarket approval

application (PMA) until FDA issues a

final regulation under section 515(b) of

the act (21 U.S.C. 360e(b)) requiring

premarket approval.

Consistent with the act and the

regulations, FDA consulted with the

General Hospital and Personal Use

Devices Panel (the Panel), an FDA

advisory committee, regarding the

classification of these devices.

The FDAMA added a new section

510(l) to the act. New section 510(l) of

the act provides that a class I device is

exempt from the premarket notification

requirements under section 510(k) of the

act, unless the device is intended for a

use which is of substantial importance

in preventing impairment of human

health or it presents a potential

unreasonable risk of illness or injury.

Hereafter, these are referred to as

‘‘reserved criteria.’’ FDA has considered

the general purpose disinfectants in

accordance with the reserved criteria

and determined that these devices do

not require premarket notification. Such

an exemption permits manufacturers to

introduce into commercial distribution

generic types of devices without first

submitting a premarket notification to

FDA.

II. Regulatory History of the Device

In the Federal Register of November

6, 1998 (63 FR 59917), FDA proposed to

classify both liquid chemical sterilants

intended for use as the terminal step in

processing critical and semicritical

medical devices prior to patient use into

class II and general purpose

disinfectants intended to process

noncritical medical devices and

equipment surfaces into class I. In the

same issue of the Federal Register, FDA

proposed to exempt the general purpose

disinfectants from the premarket

notification requirements. FDA

recognizes a ‘‘high level disinfectant’’ as

a potential separate or subordinate

condition of use of a sterilant and has

included it in the final rule to clarify its

classification status. Initially, interested

persons were given until February 4,

1999, to comment on the proposed

regulation. Subsequently, FDA extended

the comment period to March 8, 1999,

in response to an extension request.