**SUPPORTING STATEMENT**

**Cosmetic Product Voluntary Reporting Program**

**OMB No. 0910-0030 - Extension**

**A. [JUSTIFICATION]{.underline}**

**1. [Circumstances Necessitating Information Collection]{.underline}**

Under the Federal Food, Drug, and Cosmetic Act (FFDCA), cosmetic
products that are adulterated under section 601 (21 U.S.C. 361)
(Attachment A) or misbranded under section 602 (21 U.S.C. 362)
(Attachment A) cannot legally be distributed in interstate commerce. The
FFDCA does not authorize the Food and Drug Administration (FDA) to
require mandatory filing of cosmetic product formulations. To assist FDA
in carrying out its responsibility to regulate cosmetics, FDA has
developed the Voluntary Cosmetic Registration Program (VCRP). As part of
this program, FDA requests that establishments that manufacture,
package, or distribute cosmetics voluntarily file cosmetic product
formulations and notices of discontinuance of commercial distribution of
cosmetic product formulations. The regulations describing FDA's requests
for this information are given in 21 CFR part 720 (Attachment A). FDA
requests that this information be submitted to FDA's Office of Cosmetics
and Colors on Forms FDA 2512, FDA 2512a, and FDA 2514 (Attachment B).

FDA established the VCRP in response to petitions by the Cosmetic,
Toiletry, and Fragrance Association (CTFA) and issued regulations for
the program in final rules published in the Federal Registers of April
11, 1972 (37 FR 7151) and October 17, 1973 (38 FR 28914). In response to
another petition by CTFA and comments to a proposed rule (55 FR 42993,
October 25, 1990), FDA modified the VCRP by ending the reporting of
semi-quantitative ingredient information, integrating information on raw
materials into its cosmetic product ingredient statements, and ending
the voluntary reporting of cosmetic product experiences (57 FR 3128,
January 28, 1992; 62 FR 43071, August 12, 1997).

FDA requests under 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 (§§ 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 (§§ 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." (§§ 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 § 720.8.

The regulations that describe the information collection provisions of
this program are summarized as follows:

**21 CFR 720.1 Who should file.**---Manufacturers, packers, and
distributors of cosmetic products are requested to file Forms FDA 2512
and FDA 2512a, whether or not the cosmetic product enters interstate
commerce. This request extends to foreign manufacturers, packers, and
distributors of cosmetic products exported for sale in the U.S.

**21 CFR 720.2 Times for filing.**---Forms FDA 2512 and FDA 2512a should
be filed within 60 days after the beginning of commercial distribution
of any cosmetic product.

**21 CFR 720.3 How and where to file.**---Forms FDA 2512, FDA 2512a, and
FDA 2514 should be mailed to the FDA address specified in this
regulation.

**21 CFR 720.4 Information requested about cosmetic products.**---Form
FDA 2512 requests information on the name and address of the
manufacturer, packer, or distributor, brand name(s), and product
category or categories of the cosmetic product being filed. Form FDA
2512a requests information on the ingredients in the cosmetic product.
Forms should be signed by an authorized representative of the firm.

**21 CFR 720.6 Amendments to statement.**---Amended Forms FDA 2512 and
FDA 2512a should be submitted within 60 days after the product is
entered into commercial distribution if an ingredient or product brand
name is changed from that previously filed or within a year if other
changes are made. Form FDA 2514 should be submitted within 180 days
after discontinuance of commercial distribution of a filed product.

**21 CFR 720.8 Confidentiality of statements.**---Cosmetic product
filers may request confidentiality of the identity of a cosmetic
ingredient if such information is a trade secret or confidential
commercial or financial information as defined in 21 CFR 20.61. Requests
for confidentiality are subject to the provisions of this regulation and
21 CFR 20.111.

**2. [How, By Whom, Purpose of Collection]{.underline}**

This information is collected by submission of Forms FDA 2512, FDA
2512a, and FDA 2514 to FDA's Office of Cosmetics and Colors. The forms
and instructions for submitting them are available on FDA's website at
<http://www.cfsan.fda.gov/~dms/cos-regn.html>. FDA places the submitted
information in a computer data base.

FDA 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.

**3. [Consideration Given to Information Technology]{.underline}**

Forms FDA 2512, FDA 2512a, and FDA 2514 require no compilation or
arrangement of data and can be completed with a typewriter or pen. The
forms may be submitted to FDA by mail or by computer-printed facsimile.

FDA continually seeks ways to reduce the burden for reporting this
information through advances in information technology. 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 the FDA. Due to budgetary constraints and newly imposed
Department of Health and Human Services security requirements for online
Internet-based systems, which resulted from the events of September 11,
2001, implementation of this electronic submission system has been
delayed. The system is currently undergoing additional beta testing and
is planned to be implemented in FY 2005.

**4. [Identification of Duplicate Information]{.underline}**

To the best of FDA's knowledge, no other federal government agency is
engaged in the collection of this information.

**5. [Small Businesses]{.underline}**

This information collection will not have a significant economic impact
on small businesses. However, the use of Forms FDA 2512, FDA 2512a, and
FDA 2514 is expected to increase with the size of the reporting firm,
the number of products manufactured, and the turnover of product lines.
FDA aids small businesses in submitting requested information through
its administrative and scientific staffs. FDA's Small Business Guide is
available on FDA's website at <http://www.fda.gov/oc/industry/>.

**6. [Less Frequent Information Collection]{.underline}**

Original cosmetic product ingredient statements and notices of
discontinuance are submitted only once and therefore cannot be collected
less frequently. Amended cosmetic product ingredient statements are
submitted only if a manufacturer changes a cosmetic product formulation.

**7. [Information Collection Special Circumstances]{.underline}**

There are no special circumstances involving this information
collection. Submission of the information is voluntary.

**8. [Consultations with Persons Outside FDA]{.underline}**

In accordance with 5 CFR 1320.8(d), FDA published a 60-day notice for
public comment in the Federal Register of June 13, 2005 (70 FR 34142)
(Attachment C).

FDA received two letters, one from a trade association and one from a
cosmetic company, each containing one or more comments, in response to
the proposed extension of existing collection of information for part
720.

The trade association commended the agency for making the Cosmetic
Product Voluntary Reporting Program less burdensome on the cosmetic
industry by modernizing the program to take advantage of technological
advances. The cosmetic company stated, however, that the requirement for
both the ingredient name and a nine-digit identification number on FDA
Form 2512a is burdensome.

FDA appreciates the trade association's remarks as well its assistance
in making the voluntary reporting system more efficient. As to the
burdensomeness of the dual requirement expressed by the cosmetic
company, FDA expects to have its new system for electronic submission of
cosmetic ingredient information to the Cosmetic Product Voluntary
Reporting Program, which is currently in the beta testing stage,
implemented in the Fall of 2005. FDA expects that the new system will
greatly simplify the submission of cosmetic ingredient information to
the program by, among other things, permitting either the identification
number or ingredient name to be submitted (except for new ingredients).

The cosmetic company also requested that FDA accept submission of a
single Form FDA 2512 for groups of hair color preparations for which
only the amounts of color additive ingredients are varied.

FDA is not granting this request as it will be unnecessary once the
agency implements its new electronic submission system this Fall. The
agency's new electronic submission system will facilitate new
submissions by making frequently used ingredients accessible from a
"favorites" list and by making ingredient formulations previously
submitted on the paper forms accessible to users of the new system upon
proof of ownership.

The cosmetic company also requested that FDA modify the continuation
footer in the paper version of Form FDA 2512a.

FDA does not believe the requested change is necessary because the
agency expects that its new electronic submission system being
implemented this Fall will greatly reduce the use of paper versions of
FDA Forms 2512, 2512a, and 2514.

The cosmetic company suggested that FDA revise the product categories in
21 CFR 720.4(c) to include new types of products.

FDA is not making the suggested revision. The agency does not believe
this revision is necessary because each category already provides a
subcategory for "other preparations" that covers products that do not
fit in the specified subcategories.

Finally, the cosmetic company recommended that FDA's new electronic
submission system provide for direct transfer of information from
company databases to FDA's.

FDA is not permitting this recommended direct transfer of information
for security reasons. The agency has to limit the ways people can enter
data into the electronic submission system to protect the database from
corruption.

**9. [Payment or Gift]{.underline}**

There are no payments or gifts provided to respondents.

**10. [Confidentiality Provisions]{.underline}**

Authorized personnel in FDA's Office of Cosmetics and Colors receive,
evaluate, and store all information filed on Forms FDA 2512, FDA 2512a,
and FDA 2514 in secured work areas. When not being evaluated, the forms
are stored in locked file cabinets in a dedicated locked file room. As
part of the evaluation, authorized personnel add the filing information
to a computer data base. Security of the computer data base meets all
mandated Department of Health and Human Services requirements. Access to
the forms, file room, and computer data base is limited to authorized
personnel.

Under 21 CFR 720.8, cosmetic product ingredient filers may request
confidentiality of the identity of a cosmetic ingredient if such
information is a trade secret or confidential commercial or financial
information as defined in 21 CFR 20.61. Requests for confidentiality are
subject to the provisions of 21 CFR 20.111 and 21 CFR 20 subparts D and
E. If FDA grants the request, the information is not available for
public disclosure.

FDA shares non-confidential information from its files on cosmetics with
consumers, medical professionals, and the cosmetic industry.
Non-confidential information is releasable to the public under FDA
compliance with the Freedom of Information Act. All release of
information must be authorized by management staff in FDA's Office of
Cosmetics and Colors and is processed by the agency's Division of
Freedom of Information.

**11. [Privacy]{.underline}**

This information collection does not ask questions of a sensitive
nature.

**12. [Burden of Information Collection]{.underline}**

\(a\) Estimate of burden hours

The estimated annual total hour burden for this collection of
information is 742 hours. This estimate is based on submissions received
from fiscal years FY 2002 to FY 2004. The estimated time required for
each submission is based on information from cosmetic industry
personnel.

Table 1 summarizes the estimated annual reporting burden for this
information collection.

+-------------+--------+--------+--------+--------+--------+--------+
| Table       |        |        |        |        |        |        |
| 1.-         |        |        |        |        |        |        |
| --Estimated |        |        |        |        |        |        |
| Annual      |        |        |        |        |        |        |
| Reporting   |        |        |        |        |        |        |
| Burden      |        |        |        |        |        |        |
+=============+========+========+========+========+========+========+
| 21 CFR      | FDA    | No. of | Annual | Total  | Hours  | Total  |
| Section     | Form   | Respo  | Fre    | Annual | per    | Hours  |
|             | No.    | ndents | quency | Res    | Re     |        |
|             |        |        | per    | ponses | sponse |        |
|             |        |        | Re     |        |        |        |
|             |        |        | sponse |        |        |        |
+-------------+--------+--------+--------+--------+--------+--------+
| 720.1       | 2512   | 112    | 12.9   | 1446   | 0.5    | 723    |
| through     |        |        |        |        |        |        |
| 720.4 (new  | 2512a  |        |        |        |        |        |
| s           |        |        |        |        |        |        |
| ubmissions) |        |        |        |        |        |        |
+-------------+--------+--------+--------+--------+--------+--------+
| 720.3,      | 2512   | 112    | 0.5    | 52     | 0.33   | 17     |
| 720.4, and  |        |        |        |        |        |        |
| 720.6       | 2512a  |        |        |        |        |        |
| (           |        |        |        |        |        |        |
| amendments) |        |        |        |        |        |        |
+-------------+--------+--------+--------+--------+--------+--------+
| 720.3 and   | 2514   | 112    | 1      | 4      | 0.1    | 0.4    |
| 720.6       |        |        |        |        |        |        |
| (notices of |        |        |        |        |        |        |
| disc        |        |        |        |        |        |        |
| ontinuance) |        |        |        |        |        |        |
+-------------+--------+--------+--------+--------+--------+--------+
| 720.8       |        | 1      | 1      | 1      | 1.5    | 1.5    |
| (requests   |        |        |        |        |        |        |
| for         |        |        |        |        |        |        |
| confi       |        |        |        |        |        |        |
| dentiality) |        |        |        |        |        |        |
+-------------+--------+--------+--------+--------+--------+--------+
| Total       |        | 112    |        | 1503   |        | 742    |
+-------------+--------+--------+--------+--------+--------+--------+

\(b\) Estimated Cost Associated with Burden

> The estimated annualized cost to respondents for the hour burden for
> this collection of information is 742 total annual burden hours times
> \$30 per hour (\$22,260). To account for overhead, this cost is
> increased by 100 percent, making the total estimated burden hour cost
> to the respondent \$44,520.

**13. [Costs to Respondents]{.underline}**

There are no capital costs or operating and maintenance costs associated
with this collection of information.

**14. [Costs to Federal Government]{.underline}**

FDA estimates that 2.8 professional staff persons per year (5,824 hours)
are needed to process submitted forms and maintain computer files. Using
an hourly wage of \$30 per hour, FDA estimates the annual staff cost to
be \$174,720. FDA estimates total direct and indirect costs (overhead)
to be \$21,200. FDA did not reorder preprinted Forms FDA 2512, FDA
2512a, and FDA 2514 because of leftover stock from the previous order.
FDA estimates the total annual cost to FDA for this information
collection is \$195,920. In addition, FDA has a \$100,000 one-time cost
for initiating the electronic submission system.

**15. [Reason for Change]{.underline}**

The estimated annual total hour burden is 75% 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 three years.

The increase in the total annual cost burden to the respondent is due to
estimated cost of living increases in the wage rate and the addition of
overhead costs.

**16. [Statistical Reporting]{.underline}**

No comprehensive statistical reporting, tabulation, or publication of
the data are planned.

**17. [Display of OMB Approval Date]{.underline}**

FDA is not seeking not to display the OMB approval date.

**18. [Exceptions to "Certification for Paperwork Reduction Act
Submissions"]{.underline}**

There are no exceptions to the certification statement identified in
Item 19 of OMB Form 83-I, "Certification for Paperwork Reduction Act
Submissions."

**B. [COLLECTIONS OF INFORMATION USING STATISTICAL
METHODS]{.underline}**

This information collection does not use statistical methods.

**Attachment A**

**Statutes and Regulations**

**Attachment B**

**Form FDA 2512, Form FDA 2512a, and Form FDA 2514**

**Attachment C**

**Federal Register of June 13, 2005 (70 FR 34142)**