Food and Drug Administration, HHS.
The Food and Drug Administration (FDA or we) 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 information collection provisions in FDA's cosmetic labeling regulations.
Submit either electronic or written comments on the collection of information by June 16, 2014.
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.
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FOR FURTHER INFORMATION CONTACT:
FDA PRA Staff, Office of Operations, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, PRAStaff@fda.hhs.gov.
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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, we are publishing notice of the proposed collection of information set forth in this document.
With respect to the following collection of information, we invite 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.
Cosmetic Labeling Regulations—21 CFR Part 701 (OMB Control Number 0910-0599)—Extension
The Federal Food, Drug, and Cosmetic Act (the FD&C Act) and the Fair Packaging and Labeling Act (the 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, respectively) 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.
FDA's cosmetic labeling regulations are published in part 701 (21 CFR part 701). Four of the cosmetic labeling regulations have information collection provisions. 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.
We estimate the annual burden of this collection of information as follows:
Table 1—Estimated Annual Third-Party Disclosure Burden 1
|21 CFR Section/Activity||Number of respondents||Number of disclosures
respondent||Total annual disclosures||Average burden per
|701.3/Ingredients in order of predominance||1,518||21||31,878||1||31,878|
|701.11/Statement of identity||1,518||24||36,432||1||36,432|
|701.12/Name and place of business||1,518||24||36,432||1||36,432|
|701.13/Net quantity of contents||1,518||24||36,432||1||36,432|
|1 There are no capital costs or operating and maintenance costs associated with this collection of information.|
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 need to design Start Printed Page 21767labels because they increase the number of label elements that establishments must take into account 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.
The estimated annual third party disclosure is based on data available to the Agency, our knowledge of and experience with cosmetic labeling, and our communications with industry. We estimate there are 1,518 cosmetic product establishments in the United States. We calculate label design costs based on stock keeping units (SKUs) because each SKU has a unique product label. Based on data available to the Agency and on communications with industry, we estimate that cosmetic establishments will offer 94,800 SKUs for retail sale in 2014. This corresponds to an average of 62 SKUs per establishment.
One of the four provisions that we discuss in this information collection, § 701.3, applies only to cosmetic products offered for retail sale. However, the other three provisions, §§ 701.11, 701.12, and 701.13, apply to all cosmetic products, including non-retail professional-use-only products. We estimate that including professional-use-only cosmetic products increases the total number of SKUs by 15 percent to 109,020. This corresponds to an average of 72 SKUs per establishment.
Finally, based on the Agency's experience with other products, we estimate that cosmetic establishments may redesign up to one-third of SKUs per year. Therefore, we estimate that the number of disclosures per respondent will be 21 (31,878 SKUs) for § 701.3 and 24 each (36,432 SKUs) for §§ 701.11, 701.12, and 701.13.
We estimate that each of the required label elements may add approximately 1 hour to the label design process. We base this estimate on the hour burdens the Agency has previously estimated for food, drug, and medical device labeling and on the Agency's knowledge of cosmetic labeling. Therefore, we estimate that the total hour burden on members of the public for this information collection is 141,174 hours per year.
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Dated: April 11, 2014.
Assistant Commissioner for Policy.
[FR Doc. 2014-08708 Filed 4-16-14; 8:45 am]
BILLING CODE 4160-01-P