Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Cosmetic Labeling Regulations and Voluntary Cosmetic Registration Program

Published date23 July 2020
Citation85 FR 44539
Record Number2020-15996
SectionNotices
CourtFood And Drug Administration
Federal Register, Volume 85 Issue 142 (Thursday, July 23, 2020)
[Federal Register Volume 85, Number 142 (Thursday, July 23, 2020)]
                [Notices]
                [Pages 44539-44541]
                From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
                [FR Doc No: 2020-15996]
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                DEPARTMENT OF HEALTH AND HUMAN SERVICES
                Food and Drug Administration
                [Docket No. FDA-2008-N-0490]
                Agency Information Collection Activities; Submission for Office
                of Management and Budget Review; Comment Request; Cosmetic Labeling
                Regulations and Voluntary Cosmetic Registration Program
                AGENCY: Food and Drug Administration, HHS.
                ACTION: Notice.
                -----------------------------------------------------------------------
                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: Submit written comments (including recommendations) on the
                collection of information by August 24, 2020.
                ADDRESSES: To ensure that comments on the information collection are
                received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
                collection by selecting ``Currently under Review--Open for Public
                Comments'' or by using the search function. The OMB control number for
                this information collection is 0910-0599. Also include the FDA docket
                number found in brackets in the heading of this document.
                FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
                Food and Drug Administration, Three White Flint North, 10A-12M, 11601
                Landsdown St., North Bethesda, MD 20852, 301-796-5733,
                [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.
                Cosmetic Labeling Regulations--21 CFR part 701 and Voluntary Cosmetic
                Registration Program--21 CFR parts 710 and 720
                OMB Control Number 0910-0599--Revision
                 The Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair
                Packaging and Labeling Act (FPLA) require that cosmetic manufacturers,
                packers, and distributors disclose information about themselves or
                their products on the labels or labeling of their products. Sections
                201, 301, 502, 601, 602, 603, 701, and 704 of the FD&C Act (21 U.S.C.
                321, 331, 352, 361, 362, 363, 371, and 374) and sections 4 and 5 of the
                FPLA (15 U.S.C. 1453 and 1454) provide authority to FDA to regulate the
                labeling of cosmetic products. Failure to comply with the requirements
                for cosmetic labeling may render a cosmetic adulterated under section
                601 of the FD&C Act or misbranded under section 602 of the FD&C Act.
                I. Cosmetic Labeling Regulations
                 FDA's cosmetic labeling regulations are codified in part 701 (21
                CFR part 701). Section 701.3 requires the label of a cosmetic product
                to bear a declaration of the ingredients in descending order of
                predominance. Section 701.11 requires the principal display panel of a
                cosmetic product to bear a statement of the identity of the product.
                Section 701.12 requires the label of a cosmetic product to specify the
                name and place of business of the manufacturer, packer, or distributor.
                Section 701.13 requires the label of a cosmetic product to declare the
                net quantity of contents of the product. The information collection
                provisions found in part 701 are currently approved under OMB control
                number 0910-0027. To improve the efficiency of Agency operations, we
                are consolidating these information collection elements into OMB
                control number 0910-0599.
                II. Voluntary Cosmetic Registration Program
                 Information collection associated with our Voluntary Cosmetic
                Registration Program (VCRP) are found in parts 710 and 720 (21 CFR
                parts 710 and 720). Participants have the option of submitting
                information via paper forms or via an online interface. The use of the
                term ``form'' refers to both the paper form and the online system.
                 Pursuant to 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 website at https://www.fda.gov/cosmetics/voluntary-cosmetic-registration-program/online-registration-voluntary-cosmetic-registration-program-vcrp. We 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
                [[Page 44540]]
                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 store 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.
                 Pursuant to part 720, we request 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 also 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, we
                request that the firm notify FDA that they have discontinued a cosmetic
                product formulation by submitting an amended Form FDA 2512. 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 use of an electronic submission system has been designed to
                make it easier for participants to provide information to FDA about
                their products. The online version of Forms FDA 2512 and FDA 2512a are
                available on our VCRP website at https://www.fda.gov/cosmetics/voluntary-cosmetic-registration-program/online-registration-voluntary-cosmetic-registration-program-vcrp.
                 Description of Respondents: Respondents to this collection of
                information include cosmetic manufacturers, packers, and distributors.
                Respondents are from the private sector (for-profit businesses).
                 In the Federal Register of April 3, 2020 (85 FR 18993), we
                published a 60-day notice requesting public comment on the proposed
                collection of information. One comment was received communicating
                general support for the information collection.
                 We estimate the burden of this collection of information as
                follows:
                 Table 1--Estimated Annual Third-Party Disclosure Burden \1\
                ----------------------------------------------------------------------------------------------------------------
                 Number of Average
                 21 CFR section; activity Number of disclosures per Total annual burden per Total hours
                 respondents respondent disclosures disclosure
                ----------------------------------------------------------------------------------------------------------------
                701.3; ingredients in order of 1,518 21 31,878 1 31,878
                 predominance.................
                701.11; statement of identity. 1,518 24 36,432 1 36,432
                701.12; name and place of 1,518 24 36,432 1 36,432
                 business.....................
                701.13; net quantity of 1,518 24 36,432 1 36,432
                 contents.....................
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                 Total..................... .............. ................ .............. .............. 141,174
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                \1\ There are no capital costs or operating and maintenance costs associated with this collection of
                 information.
                 The estimated annual third-party disclosure burden is based on data
                available to the Agency, our knowledge of and experience with
                cosmetics, and communications with industry. The hour burden is the
                additional or incremental time that establishments need to design and
                print labeling that includes the following required elements: A
                declaration of ingredients in decreasing order of predominance, a
                statement of the identity of the product, a specification of the name
                and place of business of the establishment, and a declaration of the
                net quantity of contents. These requirements increase the time
                establishments needed to design labels because they increase the number
                of label elements that establishments must consider when designing
                labels. These requirements do not generate any recurring burden per
                label because establishments must already print and affix labels to
                cosmetic products as part of normal business practices. We estimate
                that the total third-party disclosure burden is 141,174 hours.
                 Table 2--Estimated Annual Reporting Burden \1\
                --------------------------------------------------------------------------------------------------------------------------------------------------------
                 Average
                 Number of Number of Total annual burden per
                 21 CFR section or part Form FDA No. respondents responses per responses response Total hours
                 respondent (minutes)
                --------------------------------------------------------------------------------------------------------------------------------------------------------
                Part 710 (registrations)................................ \2\ 2511 1,702 1 1,702 0.20 340
                 (12)
                720.1 through 720.4 (new submissions)................... \3\ 2512 6,843 1 6,843 0.33 (20) 2,258
                720.6 (amendments)...................................... 2512 2,477 1 2,477 0.17 (10) 421
                720.6 (notices of discontinuance)....................... 2512 232 1 232 0.10 (6) 23
                720.8 (requests for confidentiality).................... .............. 1 1 1 2 2
                 -----------------------------------------------------------------------------------------------
                 Total............................................... .............. .............. .............. .............. .............. 3,044
                --------------------------------------------------------------------------------------------------------------------------------------------------------
                \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/voluntary-cosmetic-registration-program/online-registration-voluntary-cosmetic-registration-program-vcrp.
                [[Page 44541]]
                
                \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/voluntary-cosmetic-registration-program/online-registration-voluntary-cosmetic-registration-program-vcrp.
                 We base our estimate on 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, 1,702 establishments that manufacture or package cosmetic
                products will each submit 1 registration on Form FDA 2511, for a total
                of 1,702 annual responses. Each submission is estimated to take about
                0.20 hour per response for a total of 340.4 hours, rounded to 340. We
                estimate that, annually, firms that manufacture, pack, or distribute
                cosmetics will file 6,843 ingredient statements for new submissions on
                Forms FDA 2512 and FDA 2512a. Each submission is estimated to take
                about 0.33 hour per response for a total of 2,258.19 hours, rounded to
                2,258. We estimate that, annually, firms that manufacture, pack, or
                distribute cosmetics will file 2,477 amendments to product formulations
                on Forms FDA 2512 and FDA 2512a. Each submission is estimated to take
                about 0.17 hour per response for a total of 421.09 hours, rounded to
                421. We estimate that, annually, firms that manufacture, pack, or
                distribute cosmetics will file 232 notices of discontinuance on Form
                FDA 2512. Each submission is estimated to take about 0.10 hour per
                response for a total of 23.2 hours, rounded to 23. 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 estimated total reporting burden is 3,044 hours.
                 Our estimated burden for the information collection reflects an
                overall increase of 3,044 hours and a corresponding increase of 11,255
                responses. We attribute this adjustment to an increase in the number of
                hours and responses due to the consolidation of OMB control numbers
                0910-0027 and 0910-0599. Total burden for the combined collection of
                information is therefore, 144,218 hours (141,174 hours from OMB control
                number 0910-0599 and 3,044 hours from OMB control number 0910-0027).
                 Dated: July 20, 2020.
                Lauren K. Roth,
                Associate Commissioner for Policy.
                [FR Doc. 2020-15996 Filed 7-22-20; 8:45 am]
                BILLING CODE 4164-01-P
                

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