[Federal Register Volume 79, Number 25 (Thursday, February 6, 2014)]
[Notices]
[Pages 7196-7197]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-02512]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0623]


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 or we) 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 invites comments on the collection of information 
associated with our Voluntary Cosmetic Registration Program (VCRP).

DATES: Submit either electronic or written comments on the collection 
of information by April 7, 2014.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, [email protected].

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 Parts 710 and 720 (OMB 
Control Number 0910-0027)--Extension

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act) provides us 
with the authority to regulate cosmetic products in the United States. 
Cosmetic products that are adulterated under section 601 of the FD&C 
Act (21 U.S.C. 361) or misbranded under section 602 of the FD&C Act (21 
U.S.C. 362) may not be distributed in interstate commerce. We have 
developed the VCRP to assist us in carrying out our responsibility to 
regulate cosmetics.
    In 21 CFR part 710, we request that establishments that manufacture 
or package cosmetic products register with us on Form FDA 2511 entitled 
``Registration of Cosmetic Product Establishment.'' The term ``Form FDA 
2511'' refers to both the paper and electronic versions of the form. 
The electronic version of Form FDA 2511 is available on our VCRP Web 
site at http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/VoluntaryCosmeticsRegistrationProgramVCRP/OnlineRegistration/default.htm. We strongly encourage electronic registration of Form FDA 
2511 because it is faster and more convenient. A registering facility 
will receive confirmation of electronic registration, including a 
registration number, by email, usually within 7 business days. The 
online system also

[[Page 7197]]

allows for amendments to past submissions.
    Because registration of cosmetic product establishments is not 
mandatory, voluntary registration provides us with the best information 
available about the locations, business trade names, and types of 
activity (manufacturing or packaging) of cosmetic product 
establishments. We place the registration information in a computer 
database and use the information to generate mailing lists for 
distributing regulatory information and for inviting firms to 
participate in workshops on topics in which they may be interested. We 
also use the information for estimating the size of the cosmetic 
industry and for conducting onsite establishment inspections. 
Registration is permanent, although we request that respondents submit 
an amended Form FDA 2511 if any of the originally submitted information 
changes.
    In part 720 (21 CFR part 720), we request that firms that 
manufacture, pack, or distribute cosmetics file with us 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.  720.6) 
also are reported on Forms FDA 2512 and FDA 2512a. When a firm 
discontinues the commercial distribution of a cosmetic, we request that 
the firm file Form FDA 2514, ``Notice of 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 is available on FDA's VCRP Web site at 
http://wcms.fda.gov/FDAgov/Cosmetics/GuidanceComplianceRegulatoryInformation/VoluntaryCosmeticsRegistrationProgramVCRP/OnlineRegistration/default.htm. 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.
    We place cosmetic product filing information in a computer database 
and use the information for evaluation of cosmetic products currently 
on the market. Because filing of cosmetic product formulations is not 
mandatory, voluntary filings provide us 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 our scientists in evaluating 
reports of alleged injuries and adverse reactions from the use of 
cosmetics. We also use the information in defining and planning 
analytical and toxicological studies pertaining to cosmetics.
    Information from the database is releasable to the public under our 
compliance with the Freedom of Information Act. We share 
nonconfidential information from our files on cosmetics with consumers, 
medical professionals, and industry.
    We estimate the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                              Annual
          21 CFR section or part                      Form No.               Number of     frequency per   Total annual      Hours per      Total hours
                                                                            respondents      response        responses       response
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Part 710 (registrations)..................  FDA 2511 \2\................              81               1              81             0.2              16
720.1 through 720.4 (ingredient statements  FDA 2512 \3\................           4,877               1           4,877            0.33           1,609
 for new submissions).
720.6 (amendments)........................  FDA 2512....................           1,042               1           1,042            0.17             177
720.6 (notices of discontinuance).........  FDA 2512....................           1,826               1           1,826             0.1             183
720.8 (requests for confidentiality)......  ............................               1               1               1             2.0               2
                                                                         -------------------------------------------------------------------------------
    Total.................................  ............................  ..............  ..............  ..............  ..............           1,987
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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 2511'' refers to both the paper Form FDA 2511 and electronic Form FDA 2511 in the electronic system known as the Voluntary
  Cosmetic Registration Program, which is available at http://wcms.fda.gov/FDAgov/Cosmetics/GuidanceComplianceRegulatoryInformation/VoluntaryCosmeticsRegistrationProgramVCRP/OnlineRegistration/default.htm.
\3\ The term ``Form FDA 2512'' refers to 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://wcms.fda.gov/FDAgov/Cosmetics/GuidanceComplianceRegulatoryInformation/VoluntaryCosmeticsRegistrationProgramVCRP/OnlineRegistration/default.htm.

    We base our estimate of the total annual responses on paper and 
electronic submissions received during calendar years 2011, 2012, and 
2013. We base our estimate of the hours per response upon information 
from cosmetic industry personnel and our experience entering data 
submitted on paper Forms FDA 2511, 2512, 2512a, and 2514 into the 
electronic system.
    We estimate that, annually, 81 establishments that manufacture or 
package cosmetic products will each submit 1 registration on Form FDA 
2511, for a total of 81 annual responses. Each submission is estimated 
to take 0.2 hour per response for a total of 16.2 hours, rounded to 16. 
We estimate that, annually, firms that manufacture, pack, or distribute 
cosmetics will file 4,877 ingredient statements for new submissions on 
Forms FDA 2512 and FDA 2512a. Each submission is estimated to take 0.33 
hour per response for a total of 1,609.41 hours, rounded to 1,609. We 
estimate that, annually, firms that manufacture, pack, or distribute 
cosmetics will file 1,042 amendments to product formulations on Forms 
FDA 2512 and FDA 2512a. Each submission is estimated to take 0.17 hour 
per response for a total of 177.14 hours, rounded to 177. We estimate 
that, annually, firms that manufacture, pack, or distribute cosmetics 
will file 1,826 notices of discontinuance on Form FDA 2514. Each 
submission is estimated to take 0.1 hour per response for a total of 
182.6 hours, rounded to 183. We estimate that, annually, one firm will 
file one request for confidentiality. Each such request is estimated to 
take 2 hours to prepare for a total of 2 hours. Thus, the total 
estimated hour burden for this information collection is 1,987 hours.

    Dated: January 31, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-02512 Filed 2-5-14; 8:45 am]
BILLING CODE 4160-01-P