[Federal Register Volume 65, Number 111 (Thursday, June 8, 2000)]
[Rules and Regulations]
[Pages 36319-36324]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-14212]


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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-the-Counter 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.

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SUMMARY: The Food and Drug Administration (FDA) is extending to 
December 31, 2002, the effective date for the final monograph for over-
the-counter (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 Sec. 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 erythema-causing 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

[[Page 36320]]

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 
UVA-absorbing 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-the-counter 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 Sec. 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 
monograph-specific 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 Sec. 310.545(a)(29). The 
agency also set a 2-year effective date for new Sec. 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 Sec. 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 Sec. 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.

[[Page 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, well-understood, 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 Sec. 352.71 of the sunscreen monograph that state 
``sun at a zenith angle of 10\1/2\'' 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 erythema-effective 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 Sec. 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

[[Page 36322]]

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 Sec. 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 ``round-robin,'' 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 Sec. 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 
Sec. 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 radiation-absorbing 
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 Sec. 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 Sec. 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

[[Page 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

[[Page 36324]]

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:


Sec. 310.545  Drug products containing certain active ingredients 
offered over-the-counter (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