[Federal Register Volume 82, Number 103 (Wednesday, May 31, 2017)]
[Notices]
[Pages 24977-24980]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-11188]


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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 Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(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 July 31, 2017.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before July 31, 2017. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of July 31, 2017. Comments received by 
mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov/. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov/ 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov/.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2010-N-0623 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Voluntary Cosmetic Registration 
Program.'' Received comments, those filed in a timely manner (see 
ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov/ or at the Division of Dockets Management between 
9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov/. Submit both copies to the Division of Dockets 
Management. If you do not wish your name and contact information to be 
made publicly available, you can provide this information on the cover 
sheet and not in the body of your comments and you must identify this 
information as ``confidential.'' Any information marked as 
``confidential'' will not be disclosed except in accordance with 21 CFR 
10.20 and other applicable disclosure law. For more information about 
FDA's posting of comments to public dockets, see 80 FR 56469, September 
18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov/ and insert the docket number, found in brackets in 
the

[[Page 24978]]

heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ila 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: 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.
    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) decreasing burden to 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 term ``Form FDA 2511'' refers to both the paper 
and online versions of the form. 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 of 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 mailing 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.
    Currently, under part 720, FDA requests firms that manufacture, 
pack, or distribute cosmetics to file with the Agency an ingredient 
statement for each of their products. Filing of cosmetic product 
ingredient statements is voluntary. Ingredient statements for new 
submissions are reported on Form FDA 2512, ``Cosmetic Product 
Ingredient Statement,'' and on Form FDA 2512a, a continuation form. 
Amendments to product formulations 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''; however, filers may also notify FDA that they have 
discontinued a cosmetic product formulation by submitting an amended 
Form FDA 2512, which would obviate the need for Form FDA 2514. If any 
of the information submitted on these forms is confidential, the firm 
may submit a request for confidentiality of a cosmetic ingredient.
    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. They 
also assist 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 through the use of a 
manual process for

[[Page 24979]]

both filers and FDA reviewers that can 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, 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, 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 fields such as phone number, email, and 
alternative authorized individual to Form 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.''
    We estimate the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                           Number of
        21 CFR Section or Part             Form No.        Number of     responses per   Total annual       Average burden  per response     Total hours
                                                          respondents     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 
cosmetics will file 4,049 amendments to

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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: May 25, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-11188 Filed 5-30-17; 8:45 am]
 BILLING CODE 4164-01-P