[Federal Register: June 13, 2005 (Volume 70, Number 112)]
[Page 34142-34144]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2005N-0217]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Cosmetic Product Voluntary Reporting Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the collection of information 
associated with the Cosmetic Product Voluntary Reporting Program.

DATES: Submit written or electronic comments on the collection of 
information by August 12, 2005.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Submit written comments on 

the collection of information to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests

[[Page 34143]]

or requirements that members of the public submit reports, keep 
records, or provide information to a third party. Section 3506(c)(2)(A) 
of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to 
provide a 60-day notice in the Federal Register concerning each 
proposed collection of information, including each proposed extension 
of an existing collection of information, before submitting the 
collection to OMB for approval. To comply with this requirement, FDA is 
publishing notice of the proposed collection of information set forth 
in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Cosmetic Product Voluntary Reporting Program--21 CFR Part 720 (OMB 
Control Number 0910-0030)--Extension

    Under the Federal Food, Drug, and Cosmetic Act (the act), cosmetic 
products that are adulterated under section 601 of the act (21 U.S.C. 
361), or misbranded under section 602 of the act (21 U.S.C. 362), 
cannot legally be distributed in interstate commerce. To assist FDA in 
carrying out its responsibility to regulate cosmetics, FDA requests 
under part 720 (21 CFR part 720), but does not require, that firms that 
manufacture, pack, or distribute cosmetics file with the agency an 
ingredient statement for each of their products. Ingredient statements 
for new submissions (Sec. Sec.  720.1 through 720.4) are reported on 
Form FDA 2512, ``Cosmetic Product Ingredient Statement,'' and on Form 
FDA 2512a, a continuation form. Amendments to product formulations 
(Sec. Sec.  720.3, 720.4, and 720.6) also are reported on Forms FDA 
2512 and FDA 2512a. When a firm discontinues the commercial 
distribution of a cosmetic, FDA requests that the firm file Form FDA 
2514, ``Discontinuance of Commercial Distribution of Cosmetic Product 
Formulation'' (Sec. Sec.  720.3 and 720.6). If any of the information 
submitted on or with these forms is confidential, the firm may submit a 
request for confidentiality under Sec.  720.8.
    FDA places cosmetic product filing information in a computer 
database and uses the information for evaluation of cosmetic products 
currently on the market. Because filing of cosmetic product 
formulations is not mandatory, voluntary filings provide FDA with the 
best information available about cosmetic product ingredients and their 
frequency of use, businesses engaged in the manufacture and 
distribution of cosmetics, and approximate rates of product 
discontinuance and formula modifications. The information assists FDA 
scientists in evaluating reports of alleged injuries and adverse 
reactions from the use of cosmetics. The information also is used in 
defining and planning analytical and toxicological studies pertaining 
to cosmetics.
    Information from the database is releasable to the public under FDA 
compliance with the Freedom of Information Act. FDA shares 
nonconfidential information from its files on cosmetics with consumers, 
medical professionals, and industry.
    FDA has developed an electronic submission system for filing Forms 
FDA 2512, FDA 2512a, and FDA 2514 that will reduce the reporting burden 
for respondents and FDA. The system is currently undergoing additional 
beta testing and implementation is anticipated for summer 2005.
    FDA estimates the annual burden of this collection of information 
as follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
  21 CFR                                       Annual Frequency     Total Annual     Hours per
  Section    Form No.    No. of Respondents      per Response        Responses        Response      Total Hours
720.1       FDA 2512                     112               12.9             1,446           0.5              723
 through     and FDA
 720.4       2512a
720.4 and   FDA 2512                     112                0.5                52           0.33              17
 720.6       and FDA
 (amendmen   2512a
720.3 and   FDA 2514                     112                1                   4           0.1              0.4
720.8       .........                      1                1                   1           1.5              1.5
Total                                                                                                        742
\1\ There are no capital costs or operating and maintenance costs associated with this collection of

[[Page 34144]]

    These estimates are based on FDA's experience with the Cosmetic 
Product Voluntary Reporting Program. The estimated annual total hour 
burden is 75 percent of the burden reported in 2002 due to decreased 
submissions. However, the number of respondents doubled, and FDA 
attributes this to increased interest in the program. FDA expects the 
number of submissions to increase accordingly in the next 3 years.

    Dated: June 6, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-11641 Filed 6-10-05; 8:45 am]