[Federal Register Volume 79, Number 82 (Tuesday, April 29, 2014)]
[Notices]
[Pages 23981-23982]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-09692]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 
that a proposed collection of information has been submitted to the 
Office of Management and Budget (OMB) for review and clearance under 
the Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by May 29, 
2014.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0027. 
Also include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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/RegistrationProgram/OnlineRegistration/ucm090947.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 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,

[[Page 23982]]

``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://www.fda.gov/Cosmetics/RegistrationProgram/OnlineRegistration/ucm100241.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.
    In the Federal Register of February 6, 2014 (79 FR 7196), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates 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.                No. 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             2.0
    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://www.fda.gov/Cosmetics/RegistrationProgram/OnlineRegistration/ucm090947.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://www.fda.gov/Cosmetics/RegistrationProgram/OnlineRegistration/ucm100241.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 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 2.0 hours. Thus, the total 
estimated hour burden for this information collection is 1,987 hours.

    Dated: April 21, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09692 Filed 4-28-14; 8:45 am]
BILLING CODE 4160-01-P