Notice: Safety and Efficacy Review for Additional Ingredients in Over-
the-Counter Drug Products for Human Use; Request for Environmental 
Impact Data and Information

Federal Register: February 22, 2010 (Volume 75, Number 34)             
                  Page 7606-7608

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Request for data and information.

SUMMARY:  We (Food and Drug Administration (FDA)) are requesting data 
and information regarding the potential environmental impact of 
amending over-the-counter (OTC) drug monographs to include certain 
active ingredients not previously marketed in the United States or 
marketed in the United States under approved applications after the OTC 
drug review began in 1972. Thirteen active ingredients have been found 
eligible for potential inclusion in OTC drug monographs based on time 
and extent applications (TEAs). We are currently evaluating the safety 
and effectiveness of these ingredients.

DATES:  Submit data, information, and general comments by May 24, 2010.

ADDRESSES:  Submit electronic or written data, information, and general 
comments in response to this document. Submit electronic comments to 
http://regulations.gov. Submit written comments to the Division of 
Dockets Management HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 
20852.

FOR FURTHER INFORMATION CONTACT:  Michael L. Koenig, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 5411, Silver Spring, MD 20993-0002, 301-
796-2090.

SUPPLEMENTARY INFORMATION:

I. Ingredients Affected by This Notice

    We are currently evaluating the safety and effectiveness of 13 
active ingredients found eligible for possible addition to an OTC drug 
monograph via the TEA process described in 21 CFR 330.14. The 
ingredients under review are shown in table 1 of this document:

[[Page 7607]]



    Table 1.--List of active ingredients found eligible for possible
                    addition to an OTC drug monograph
------------------------------------------------------------------------
 Active Ingredient      Monograph        Docket No.       Eligibility
------------------------------------------------------------------------
Amiloxate           Sunscreen          FDA-2003-N-019  July 11, 2003, 68
                                        6               FR 41386
------------------------------------------------------------------------
Bemotrizinol        Sunscreen          FDA-2005-N-045  December 5, 2005,
                                        3               70 FR 72449
------------------------------------------------------------------------
Bisoctrizole        Sunscreen          FDA-2005-N-045  December 5, 2005,
                                        3               70 FR 72449
------------------------------------------------------------------------
Climbazole          Dandruff           FDA-2005-N-002  December 5, 2005,
                                        1               70 FR 72448
------------------------------------------------------------------------
Diethylhexyl        Sunscreen          FDA-2006-O-031  July 26, 2006, 71
 butamido triazone                      4               FR 42405
------------------------------------------------------------------------
Ecamsule\1\         Sunscreen          FDA-2008-N-047  September 12,
                                        4               2008, 73 FR
                                                        53029
------------------------------------------------------------------------
Enzacamene          Sunscreen          FDA-2003-N-019  July 11, 2003, 68
                                        6               FR 41386
------------------------------------------------------------------------
Octyl triazone      Sunscreen          FDA-2003-N-019  July 11, 2003, 68
                                        6               FR 41386
------------------------------------------------------------------------
Piroctone olamine   Dandruff           FDA-2004-N-003  February 18,
                                        7               2004, 69 FR 7652
------------------------------------------------------------------------
Sodium picosulfate  Laxative           FDA-2006-O-005  June 22, 2006, 71
                                        7               FR 35917
------------------------------------------------------------------------
Sodium shale oil    Dandruff           FDA-2009-N-014  April 7, 2009, 74
 sulfonate                              6               FR 15741
------------------------------------------------------------------------
Triclosan           Acne               FDA-2005-N-045  December 5, 2005,
                                        4               70 FR 72447
------------------------------------------------------------------------
Triclosan\1\        Antigingivitis/    FDA-1981-N-001  July 6, 2004, 69
                     Antiplaque         5               FR 40640
------------------------------------------------------------------------
\1\ These ingredients are marketed under approved new drug applications
  (NDAs).

    When our initial assessment of safety and effectiveness data for 
any of these ingredients is complete, we will prepare a proposed rule 
describing our conclusions, which may include a proposal to add the 
ingredient to an OTC drug monograph. Such an action would be subject to 
the National Environmental Policy Act of 1969 (NEPA). In order to 
comply with NEPA, we need data and information regarding the potential 
environmental impact if these ingredients are included in an OTC drug 
monograph, especially if this results in their use in drug products 
marketed in the United States for the first time (see section II of 
this document). We did not previously request such data and information 
for these 13 active ingredients. Therefore, we are requesting such data 
at this time. We cannot publish proposed rules for any of these 13 
active ingredients until we receive this data and information.

II. Data Being Requested

    As stated in 21 CFR 25.1, FDA regulations must comply with NEPA. To 
comply with NEPA, an environmental assessment (EA) of agency actions is 
required unless we determine that a categorical exclusion is warranted. 
Many actions on OTC drug monographs have been categorically excluded 
from the NEPA requirement for an EA under Sec.  25.31(a) (21 CFR 
25.31(a)), because, for active ingredients already marketed in the 
United States, the actions generally have not resulted in increased use 
of active ingredient. However, if we amend a monograph to include a new 
generally recognized as safe and effective (GRASE) active ingredient 
not previously marketed in the United States, this exclusion would not 
apply because our action would increase the use of the active 
ingredient. This situation may occur for active ingredients found 
eligible for inclusion in an OTC drug monograph under the TEA process 
on the basis of foreign marketing experience.
    Active ingredients found eligible for potential inclusion in an OTC 
drug monograph under the TEA process might qualify for the categorical 
exclusions provided under Sec.  25.31(b) or (c). These exclusions allow 
for active ingredients that will not exceed 1 part per billion (ppb) (1 
microgram per liter) in the aquatic environment or active ingredients 
that naturally occur in the environment and do not alter significantly 
the concentration or distribution of the ingredient, its metabolites, 
or degradation products in the environment.
    In order to determine whether any of the active ingredients found 
eligible for potential inclusion in an OTC monograph meet the 
requirements for any categorical exclusion, including Sec.  25.31(b) or 
(c), or to prepare an EA, we need additional data and information. To 
assist the agency, we are requesting any information that would support 
the application of any categorical exclusion, or that would support the 
preparation of an EA, if necessary.
    To estimate the expected introductory concentration of an 
ingredient or ingredients in the aquatic environment for purposes of 
Sec.  25.31(b), please refer to section III of the CDER Guidance on 
Environmental Assessment of Human Drug and Biologic Applications (CDER 
EA Guidance Document). This guidance document can be viewed at http://
www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/ucm070561.pdf.
    To complete an EA, we need information similar to that specified in 
section IV of the CDER EA Guidance Document (pages 9-27). We request 
that a submitter segregate any data or information that the submitter 
believes is protected from disclosure by 18 U.S.C. 1905 or 21 U.S.C. 
331(j) or 360j(c). If such data or information is included in the 
submission, we request that the submitter summarize the information, to 
the extent possible, for public disclosure (see 21 CFR 25.50 and 
25.51(a)).

III. Submission of Data

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic data, information, and general 
comments. Submit a single copy of electronic data, information, and 
general comments or two paper copies of any mailed data, information, 
and general comments, except that individuals may submit one paper 
copy. Data, information, and

[[Page 7608]]

general comments are to be identified with the docket number found in 
brackets in the heading of this document. Received data, information, 
and general comments may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: February 15, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-3319 Filed 2-19-10; 8:45 am]
BILLING CODE 4160-01-S