[Federal Register Volume 82, Number 161 (Tuesday, August 22, 2017)]
[Notices]
[Pages 39795-39797]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-17701]


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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, Agency, 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 (PRA).

DATES: Fax written comments on the collection of information by 
September 21, 2017.

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: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[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 Voluntary Cosmetic Registration Program (VCRP) to assist 
us in carrying out our responsibility to regulate cosmetics.
    FDA is revising forms for the VCRP (Forms FDA 2511, 2512, 2512a, 
and 2514) currently approved under OMB control number 0910-0027, 
``Voluntary Cosmetic Registration Program,'' for the following reasons: 
(1) Modernizing the forms; (2) Making it easier for filers who complete 
the forms; and (3) reducing the time it will take FDA to review each 
submission. In addition, Form FDA 2514 will be eliminated as it 
duplicates information that is currently located on Form FDA 2512. FDA 
requests PRA approval for the proposed changes to these forms, and for 
the elimination of Form FDA 2514.
    Participation in the VCRP is voluntary under provisions found in 
sections parts 710 and 720 (21 CFR parts 710 and 720). Participants 
have the option of submitting information via paper forms or via the 
online interface. The term ``form'' refers to both the paper form and 
the online system.
    Currently, in part 710, we request that establishments that 
manufacture or package cosmetic products voluntarily register with us 
using Form FDA 2511 entitled ``Registration of Cosmetic Product 
Establishment.'' The online version of Form FDA 2511 is available on 
our VCRP Web site at https://www.fda.gov/Cosmetics/RegistrationProgram/default.htm. We strongly encourage online registration with Form FDA 
2511 because it is faster and more efficient for the filer and the 
Agency. A registering facility will receive confirmation of online 
registration, including a registration number by email. 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. We place the registration information in a computer 
database and use the information to generate lists for distributing 
regulatory information and for inviting firms to participate in 
workshops on topics in which they may be interested. Registration is 
permanent, although we request that respondents submit an amended Form 
FDA 2511 if any of the originally submitted information changes.
    FDA's proposed changes to the forms through the use of an 
electronic submission system have been designed to make it easier for 
participants to provide information to FDA about their products. The 
system also assists participants, through interactive question and 
response scenarios, to identify submissions that will be ineligible to 
be accepted in VCRP because they do not meet parts 710 and 720 
requirements. The electronic submission system is expected to reduce 
burden currently associated with the manual identification process for 
filers and FDA. The rejection rate for ineligible submissions when 
using the current forms is high: 51 percent for new accounts, 43 
percent for Form FDA 2511 registrations, and 7 percent for Form FDA 
2512 filings (2010-2016).
    The revised forms include the addition of links between Forms FDA 
2511 and 2512, clarification of what information should be entered onto 
the forms, additional self-identifying fields, removal of certain 
duplicative fields, and the deletion of Form FDA 2514. These changes 
are needed because both VCRP voluntary filer participation and FDA 
resources required to administer VCRP have increased significantly 
since 2014 (i.e., increases in new accounts (156 percent), Form FDA 
2511 registrations (405 percent), Form FDA 2512 filings (67 percent), 
and FDA review hours (59 percent) in 2016.)
    FDA's current process confirms that each submission meets the 
requirements established in parts 710 and 720 by using a manual process 
for both filers and FDA reviewers that may result in a long waiting 
period where filers must wait and respond to questions generated by 
FDA, which may result in a high rejection rate. FDA projects a 
significant reduction in rejection rates when using the revised forms. 
Examples of possible burden savings for participants and FDA include:
    (1) Form FDA 2511 asks filers if they are a manufacturer or packer; 
however, in the past, distributors and retailers have checked these 
boxes in error when neither applies to them because there are no 
distributor or retailer checkboxes on Form FDA 2511. Retailers have 
also filed Form FDA 2512 in error even though only manufacturers, 
packers,

[[Page 39796]]

and distributors are permitted to do so. To correct these issues, FDA 
revised Form FDA 2511 by updating the field that allows filers to 
indicate the ``TYPE OF ESTABLISHMENT: MANUFACTURER/PACKER/OTHER 
(Distributor or Retailer)'' and updating the field on Form FDA 2512 
allowing the filer to indicate ``WHO IS FILING THIS STATEMENT: 
MANUFACTURER/PACKER/DISTRIBUTOR/OTHER (Retailer).''
    (2) FDA revised Form FDA 2511 and added questions asking, ``Are you 
the owner or operator of this facility?'' and ``Is the address on this 
form the location of a cosmetic manufacturing and/or packing 
facility?''
    (3) FDA also revised Form FDA 2512 and added questions asking, ``Is 
this product currently commercially distributed (annual sales exceed 
$1,000) in the United States?'', ``PRODUCT WEBSITE'', and ``Attach 
images of the front and back product labels to this form'' to ensure 
that only cosmetics in commercial distribution in the United States are 
filed in the VCRP.
    (4) FDA linked Forms FDA 2511 and 2512 to reduce burden to filers 
who create multiple copies of Form FDA 2512 that share the same 
establishment addresses.
    (5) FDA clarified the information that should be included on the 
forms by attaching simplified instructions and a link to VCRP online on 
Forms FDA 2511, 2512, and 2512a and adding titles and locations of 
various fields throughout Forms FDA 2511, 2512, and 2512a. We also 
added self-identifying information such as phone number, email, and 
alternative authorized individual fields to Forms FDA 2511 and 2512 to 
facilitate communication with the filers.
    (6) We also removed fields that have no modern use or request 
redundant information in multiple locations.
    (7) We removed Form FDA 2514 in its entirety due to redundancy. (As 
noted, filers may notify FDA that they are discontinuing a cosmetic 
product formulation on Form FDA 2512).
    FDA's online filing system is available on FDA's VCRP Web site at 
https://www.fda.gov/Cosmetics/RegistrationProgram/default.htm. The 
online filing system contains the online versions of Forms FDA 2511, 
2512, and 2512a.
    We place cosmetic product filing information in a computer database 
and use the information when FDA receives inquiries about cosmetics 
marketed in the United States. Because filing of cosmetic product 
formulations is not mandatory, voluntary filings with FDA provide us 
with the best information available about cosmetic products, 
ingredients, 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 adverse events submitted via 
MedWatch and Field Operators (FACTS). We also use the information in 
identifying future research projects, to evaluate the levels and safety 
of certain ingredients in cosmetics.
    Links to explanations of the revisions to Forms FDA 2511, 2512, and 
2512a and instructions are available at https://www.fda.gov/Cosmetics/RegistrationProgram/default.htm and entitled ``Voluntary Cosmetic 
Registration Program.''
    In the Federal Register of May 31, 2017 (82 FR 24977), we published 
a 60-day notice requesting public comment on the proposed extension of 
this collection of information. Two comments were received. One comment 
appeared to be a submission under 21 CFR 10.35 and 10.40(b)(3) and 
therefore is not addressed here. The second comment offered suggestions 
that FDA might consider regarding the content and format of reporting 
elements, but made no suggestion for FDA to revise its burden estimate. 
Accordingly, while the Agency is currently reviewing these suggestions 
to determine whether our current IT system may be upgraded to the 
benefit of respondents, we retain the burden estimate from our 60-day 
notice.
    We estimate the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                  Number of
                                                                    Number of     responses      Total                                           Total
        21 CFR Section or part                  Form No.           respondents       per         annual       Average burden per response        hours
                                                                                 respondent    responses
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Part 710 (registrations).............  FDA 2511 \2\..............          934             1          934  0.20 (12 minutes)................         187
720.1 through 720.4 (new submissions)  FDA 2512 \3\..............        7,108             1        7,108  0.33 (20 minutes)................       2,346
720.6 (amendments)...................  FDA 2512..................        4,049             1        4,049  0.17 (10 minutes)................         688
720.6 (notices of discontinuance)....  FDA 2512..................           95             1           95  0.10 (6 minutes).................          10
720.8 (requests for confidentiality).  ..........................            1             1            1  2................................           2
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    Total............................  ..........................  ...........  ............  ...........  .................................       3,233
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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 online Form FDA 2511 in the online system known as the VCRP, which is
  available at https://www.fda.gov/Cosmetics/RegistrationProgram/default.htm.
\3\ The term ``Form FDA 2512'' refers to the paper Forms FDA 2512, and 2512a and online Form FDA 2512 in the online system known as the VCRP, which is
  available at https://www.fda.gov/Cosmetics/RegistrationProgram/default.htm.

    We base our estimate of the total annual responses on paper and 
online submissions received during calendar year 2016. We base our 
estimate of the hours per response upon information from cosmetic 
industry personnel and FDA experience entering data submitted on paper 
Forms FDA 2511, 2512, and 2512a into the online system.
    We estimate that, annually, 934 establishments that manufacture or 
package cosmetic products will each submit 1 registration on Form FDA 
2511, for a total of 934 annual responses. Each submission is estimated 
to take 0.20 hour per response for a total of 186.8 hours, rounded to 
187. The number of Form FDA 2511 submissions has increased 405 percent 
compared to 2014 and we have no indication that this submission rate 
will stop increasing. We estimate that, annually, firms that 
manufacture, pack, or distribute cosmetics will file 7,108 ingredient 
statements for new or amended submissions on Forms FDA 2512 and FDA 
2512a. Each submission is estimated to take 0.33 hour per response for 
a total of 2345.64 hours, rounded to 2,346. We estimate the number of 
Form FDA 2512 submissions to increase 67 percent compared to 2014 and 
we have no indication that this submission rate will stop increasing. 
We estimate that, annually, firms that manufacture, pack, or distribute

[[Page 39797]]

cosmetics will file 4,049 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 688.33 hours, rounded to 688. We estimate 
that, annually, firms that manufacture, pack, or distribute cosmetics 
will file 95 notices of discontinuance on Form FDA 2512. Each 
submission is estimated to take 0.10 hour per response for a total of 
9.5 hours, rounded to 10. 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 3,233 hours.

    Dated: August 17, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-17701 Filed 8-21-17; 8:45 am]
 BILLING CODE 4164-01-P