Food and Drug Administration, HHS.
The Food and Drug Administration (FDA 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.
Fax written comments on the collection of information by May 29, 2014.
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@example.com. 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.
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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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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 VCRP to assist us in carrying out our responsibility to regulate cosmetics.
In 21 CFR part 710, we request that establishments that manufacture or package cosmetic products register with us 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 our VCRP Web site at http://www.fda.gov/Cosmetics/RegistrationProgram/OnlineRegistration/ucm090947.htm. We strongly encourage 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 email, 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 us 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. We also use the information for estimating the size of the cosmetic industry and for conducting onsite establishment inspections. Registration is permanent, although we request that respondents submit an amended Form FDA 2511 if any of the originally submitted information changes.
In part 720 (21 CFR part 720), we request that firms that manufacture, pack, or distribute cosmetics file with us an ingredient statement for each of their products. Ingredient statements for new submissions (§§ 720.1 through 720.4) are reported on Form FDA 2512, Start Printed Page 23982“Cosmetic Product Ingredient Statement,” and on Form FDA 2512a, a continuation form. Amendments to product formulations (§ 720.6) 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 file Form FDA 2514, “Notice of Discontinuance of Commercial Distribution of Cosmetic Product Formulation” (§§ 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 § 720.8.
FDA's online filing system is available on FDA's VCRP Web site at http://www.fda.gov/Cosmetics/RegistrationProgram/OnlineRegistration/ucm100241.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.
We place cosmetic product filing information in a computer database and use the information for evaluation of cosmetic products currently on the market. Because filing of cosmetic product formulations is not mandatory, voluntary filings provide us 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 our scientists in evaluating reports of alleged injuries and adverse reactions from the use of cosmetics. We also use the information in defining and planning analytical and toxicological studies pertaining to cosmetics.
Information from the database is releasable to the public under our compliance with the Freedom of Information Act. We share nonconfidential information from our files on cosmetics with consumers, medical professionals, and industry.
In the Federal Register of February 6, 2014 (79 FR 7196), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.
FDA estimates the burden of this collection of information as follows:
Table 1—Estimated Annual Reporting Burden 1
|21 CFR Section or Part||Form no.||No. of respondents||Annual frequency per
response||Total annual responses||Hours per response||Total hours|
|Part 710 (registrations)||FDA 2511 2||81||1||81||0.2||16|
|720.1 through 720.4 (ingredient statements for new submissions)||FDA 2512 3||4,877||1||4,877||0.33||1,609|
|720.6 (amendments)||FDA 2512||1,042||1||1,042||0.17||177|
|720.6 (notices of discontinuance)||FDA 2512||1,826||1||1,826||0.1||183|
|720.8 (requests for confidentiality)||1||1||1||2.0||2.0|
|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 electronic Form FDA 2511 in the electronic system known as the Voluntary Cosmetic Registration Program, which is available at http://www.fda.gov/Cosmetics/RegistrationProgram/OnlineRegistration/ucm090947.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://www.fda.gov/Cosmetics/RegistrationProgram/OnlineRegistration/ucm100241.htm.|
We base our estimate of the total annual responses on paper and electronic submissions received during calendar years 2011, 2012 and 2013. We base our estimate of the hours per response upon information from cosmetic industry personnel and our experience entering data submitted on paper Forms 2511, 2512, 2512a, and 2514 into the electronic system.
We estimate that, annually, 81 establishments that manufacture or package cosmetic products will each submit 1 registration on Form FDA 2511, for a total of 81 annual responses. Each submission is estimated to take 0.2 hour per response for a total of 16.2 hours, rounded to 16. We estimate that, annually, firms that manufacture, pack, or distribute cosmetics will file 4,877 ingredient statements for new submissions on Forms FDA 2512 and FDA 2512a. Each submission is estimated to take 0.33 hour per response for a total of 1,609.41 hours, rounded to 1,609. We estimate that, annually, firms that manufacture, pack, or distribute cosmetics will file 1,042 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 177.14 hours, rounded to 177. We estimate that, annually, firms that manufacture, pack, or distribute cosmetics will file 1,826 notices of discontinuance on Form FDA 2514. Each submission is estimated to take 0.1 hour per response for a total of 182.6 hours, rounded to 183. 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 2.0 hours. Thus, the total estimated hour burden for this information collection is 1,987 hours.
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Dated: April 21, 2014.
Assistant Commissioner for Policy.
[FR Doc. 2014-09692 Filed 4-28-14; 8:45 am]
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