Document ID: FDA-2010-N-0623-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Voluntary Cosmetic Registration Program
Posted Date: 2010-12-15T05:00Z

[Federal Register Volume 75, Number 240 (Wednesday, December 15, 2010)]
[Notices]
[Pages 78257-78259]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-31386]

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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) 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 Agency's Voluntary Cosmetic Registration Program 
(VCRP).

DATES: Submit either electronic or written comments on the collection 
of information by February 14, 2011.

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: Denver Presley, Jr., Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850. 301-796-3793.

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)--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 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

[[Page 78258]]

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://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. 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.
    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.               Number of     frequency per   Total annual     Hours per     Total hours
                                                                              respondents      response        responses       response
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Part 710 (registrations)...................  FDA 2511 \2\.................             135               1             135           0.2            27
720.1 through 720.4 (new submissions)......  FDA 2512 \3\.................             141              31           4,371           0.33        1,442
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
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    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 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.

    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 0910-0030 will be discontinued.

[[Page 78259]]

    Dated: December 9, 2010.
Leslie Kux,
Acting Assistant, Commissioner for Policy.
[FR Doc. 2010-31386 Filed 12-14-10; 8:45 am]
BILLING CODE 4160-01-P