Document ID: FDA-2010-N-0623-0003
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Voluntary Cosmetic Registration Program
Posted Date: 2011-02-25T05:00Z

[Federal Register: February 25, 2011 (Volume 76, Number 38)]
[Notices]               
[Page 10607-10608]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25fe11-73]                         

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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) 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 March 
28, 2011.

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 e-mailed to oira_submission@omb.eop.gov. 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: Denver Presley, Jr., Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3793.

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)--Revision

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act) provides 
FDA 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. To 
assist FDA in carrying out its responsibility to regulate cosmetics, 
the Agency has developed the Voluntary Cosmetic Registration Program 
(VCRP).
    In 21 CFR part 710, FDA requests that establishments that 
manufacture or package cosmetic products register with the Agency 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 FDA's VCRP Web site at http://www.fda.gov/
Cosmetics/GuidanceComplianceRegulatoryInformation/
VoluntaryCosmeticsRegistrationProgramVCRP/OnlineRegistration/
default.htm. FDA's online registration system, intended to make it 
easier to participate in the VCRP, was made available industrywide on 
December 1, 2005. The Agency strongly encourages 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 e-mail, 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 FDA with the best 
information available about the locations, business trade names, and 
types of activity (manufacturing or packaging) of cosmetic product 
establishments. FDA places the registration information in a computer 
database and uses 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. FDA 
also uses the information for estimating the size of the cosmetic 
industry and for conducting onsite establishment inspections. 
Registration is permanent, although FDA requests that respondents 
submit an amended Form FDA 2511 if any of the originally submitted 
information changes.
    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.  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, ``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/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. The Agency strongly encourages 
electronic filing of Form FDA 2512 because it is faster and more 
convenient. A filer will receive confirmation of electronic filing by 
e-mail.
    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.
    In the Federal Register of December 15, 2010 (75 FR 78257), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received one letter, containing multiple 
comments in response to the notice.
    (Comment 1) One comment was generally supportive of the necessity 
of the information collection and its practical utility.

[[Page 10608]]

    (Response) FDA agrees that the VCRP provides the Agency with useful 
information about cosmetic product ingredients and the cosmetics 
industry.
    (Comment 2) One comment stated that, to increase participation in 
the registration program, FDA should conduct an audit of the cosmetics 
industry to determine the current participation rate in the 
registration program and to estimate how many ingredients and products 
FDA receives into the database compared to the total produced.
    (Response) FDA disagrees with the suggested audit of the cosmetics 
industry. Given that FDA does not have the statutory authority to make 
registration in the VCRP mandatory, and taking into consideration the 
cost of completing such a project, the audit would not be a wise use of 
Agency funds in the current economic environment.
    (Comment 4) As another means of increasing participation in the 
registration program, one comment suggested that FDA launch a 
certification system where companies can indicate to consumers that 
they have participated in the VCRP.
    (Response) FDA disagrees with the suggested certification program 
at this time. Before instituting such a program, FDA would need to 
conduct research to understand how consumers would interpret such a 
certification claim and would have to consider how the accuracy of such 
a claim would be enforced.
    (Comment 5) One comment stated that FDA should permit companies 
that produce professional-use products to submit contact and ingredient 
information.
    (Response) FDA disagrees with the suggested change to its 
registration program. Cosmetic products marketed in the United States 
are regulated by FDA in accordance with the requirements of the FD&C 
Act and, if offered for sale as consumer commodities, the Fair 
Packaging and Labeling Act (FPLA). The FPLA defines a consumer 
commodity as a product distributed through retail sales for consumption 
by individuals. Professional products used in salons, and free samples 
are not available through retail sale to consumers, so they are not 
considered to be in ``commercial distribution''. Because the VCRP 
program only applies to cosmetic products in commercial distribution as 
defined in the FPLA, FDA is unable to file professional cosmetic 
products.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                    No. of       Annual frequency    Total annual        Hours per
       21 CFR section or part                 Form no.            respondents      per response        responses          response         Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Part 710 (registrations)............  FDA 251 1\2\...........               135                 1               135               0.2                 27
720.1 through 720.4 (new              FDA 2512 \3\...........               141                31             4,371               0.33             1,442
 submissions).
720.6 (amendments)..................  FDA 2512...............               109                 7               763               0.17               130
720.6 (notices of discontinuance)...  FDA 2512...............                55                41             2,255               0.1                226
720.8 (requests for confidentiality)  .......................                 1                 1                 1               2.0                2.0
                                     -------------------------------------------------------------------------------------------------------------------
    Total...........................  .......................  ................  ................  ................  .................            1,827
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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 Forms FDA 2511 and electronic Form FDA 2511 in the electronic system known as the VCRP, which is
  available at http://www.fda.gov/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
  VCRP, which is available at http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/VoluntaryCosmeticsRegistrationProgramVCRP/
  OnlineRegistration/default.htm.

    FDA bases its estimate of the number of responses on submissions 
received from fiscal years 2005 to 2007. FDA bases its estimate of the 
hours per response upon information from cosmetic industry personnel 
and FDA experience entering data submitted on paper Forms 2511, 2512, 
2512a, and 2514. FDA estimates that, annually, 135 establishments that 
manufacture or package cosmetic products will each submit 1 
registration on Form FDA 2511, for a total of 135 annual responses. 
Each submission is estimated to take 0.2 hour per response for a total 
of 27 hours. FDA estimates that, annually, 141 firms that manufacture, 
pack, or distribute cosmetics will file 31 ingredient statements for 
new submissions on Forms FDA 2512 and FDA 2512a, for a total of 4,371 
annual responses. Each submission is estimated to take 0.33 hour per 
response for a total of 1,442.43 hours, rounded to 1,442. FDA estimates 
that, annually, 109 firms that manufacture, pack, or distribute 
cosmetics will file 7 amendments to product formulations on Forms FDA 
2512 and FDA 2512a, for a total of 763 annual responses. Each 
submission is estimated to take 0.17 hour per response for a total of 
129.71 hours, rounded to 130. FDA estimates that, annually, 55 firms 
that manufacture, pack, or distribute cosmetics will file 41 notices of 
discontinuance on Form FDA 2514, for a total of 2,255 annual responses. 
Each submission is estimated to take 0.1 hour per response for a total 
of 225.50 hours, rounded to 226. FDA estimates 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 
1,827 hours.
    This is a revision request in which the burden hours for the 
information collection request (ICR) under OMB control number 0910-
0030, ``Cosmetic Product Voluntary Reporting Program'' are being 
consolidated under the ICR assigned OMB control number 0910-0027, 
``Voluntary Registration of Cosmetic Product Establishments,'' which 
expires February 28, 2011. The revised ICR for 0910-0027 has been 
renamed ``Voluntary Cosmetic Registration Program.'' Upon approval of 
this revision request, the ICR for OMB control number 0910-0030 will be 
discontinued.

    Dated: February 18, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-4218 Filed 2-24-11; 8:45 am]
BILLING CODE 4160-01-P