[Federal Register Volume 73, Number 181 (Wednesday, September 17, 2008)]
[Notices]
[Pages 53877-53878]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-21617]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0490]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Voluntary Cosmetic Registration Program

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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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 Voluntary Cosmetic Registration Program.

DATES:  Submit written or electronic comments on the collection of 
information by November 17, 2008.

ADDRESSES:  Submit electronic comments on the collection of information 
to http://www.regulations.gov. 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:  Jonna Capezzuto, Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3794.

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 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.

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

    The Federal Food, Drug, and Cosmetic Act (the act) provides FDA 
with the authority to regulate cosmetic products in the United States. 
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) 
may not be distributed in interstate commerce. To assist FDA in 
carrying out its responsibility to regulate cosmetics, the agency has 
developed the Voluntary Cosmetic Registration Program (VCRP). In part 
720 (21 CFR part 720), FDA requests 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's online filing system, intended to make it easier to 
participate in the VCRP, was made available industry-wide on December 
1, 2005. The online filing system is available on FDA's VCRP Web site 
at http://www.cfsan.fda.gov/~dms/cos-regn.html. The online filing 
system contains the electronic versions of Forms FDA 2512, 2512a, and 
2514, which are collectively found within the electronic version of 
Form FDA 2512. The agency strongly encourages electronic filing of Form 
FDA 2512 because it is faster and more convenient. A filing facility 
will receive confirmation of electronic filing by e-mail. Submission of 
the paper version of Forms FDA 2512, 2512a, and 2514 remains an option 
as described in http://www.cfsan.fda.gov/~dms/cos-reg2.html. However, 
due to the high volume of online participation, the VCRP is allocating 
its limited resources primarily to electronic filings.
    FDA places cosmetic product filing information in a computer data 
base 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 estimates the burden of this collection of information as 
follows:

[[Page 53878]]



                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                 No. of       Annual Frequency    Total Annual      Hours per
 21 CFR Section   Form No.    Respondents       per Response       Responses        Response       Total Hours
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720.1 through    FDA                    141                 31             4371            0.33          1,442
 720.4 (new       2512\2\
 submissions)
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720.4 and 720.6  FDA 2512               109                  7              763            0.17            130
 (amendments)
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720.3, 720.6     FDA 2512                55                 41            2,255            0.1             226
 (notices of
 discontinuance
 )
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720.8 (requests  .........                1                  1                1            1.5               1.5
 for
 confidentialit
 y)
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Total                                                                                                    1,800
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ The term ``Form FDA 2512'' refers to both the paper Forms FDA 2512, 2512a, and 2514 and electronic Form FDA
  2512 in the electronic system known as the Voluntary Cosmetic Registration Program, which is available at
  http://www.cfsan.fda.gov/~dms/cos-regn.html.

    The estimated number of respondents is based on submissions 
received from fiscal years 2005 to 2007. The estimated time required 
for each submission is based upon information from cosmetic industry 
personnel and FDA experience entering data submitted on paper Forms FDA 
2512, 2512a, and 2514. The increase in total annual responses is due to 
increased participation by cosmetic companies, because of a renewed 
industry commitment to the program, and implementation of the online 
filing system on December 1, 2005. The decrease in hours per response 
is due to the ease of online filing.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

    Dated: September 10, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-21617 Filed 9-16-08; 8:45 am]
BILLING CODE 4160-01-S