Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) 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 the collection of information associated with the Cosmetic Product Voluntary Reporting Program.
Submit written or electronic comments on the collection of information by August 12, 2005.
Submit electronic comments on the collection of information to: http://www.fda.gov/dockets/ecomments. 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.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Peggy Robbins, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.End Further Info End Preamble Start Supplemental 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 Start Printed Page 34143or 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.
Cosmetic Product Voluntary Reporting Program—21 CFR Part 720 (OMB Control Number 0910-0030)—Extension
Under the Federal Food, Drug, and Cosmetic Act (the act), cosmetic products that are adulterated under section 601 of the act (21 U.S.C. 361), or misbranded under section 602 of the act (21 U.S.C. 362), cannot legally be distributed in interstate commerce. To assist FDA in carrying out its responsibility to regulate cosmetics, FDA requests under part 720 (21 CFR part 720), but does not require, that firms that manufacture, pack, or distribute cosmetics file with the agency an ingredient statement for each of their products. Ingredient statements for new submissions (§§ 720.1 through 720.4) are reported on Form FDA 2512, “Cosmetic Product Ingredient Statement,” and on Form FDA 2512a, a continuation form. Amendments to product formulations (§§ 720.3, 720.4, and 720.6) 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, “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 places cosmetic product filing information in a computer database and uses the information for evaluation of cosmetic products currently on the market. Because filing of cosmetic product formulations is not mandatory, voluntary filings provide FDA 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 FDA scientists in evaluating reports of alleged injuries and adverse reactions from the use of cosmetics. The information also is used in defining and planning analytical and toxicological studies pertaining to cosmetics.
Information from the database is releasable to the public under FDA compliance with the Freedom of Information Act. FDA shares nonconfidential information from its files on cosmetics with consumers, medical professionals, and industry.
FDA has developed an electronic submission system for filing Forms FDA 2512, FDA 2512a, and FDA 2514 that will reduce the reporting burden for respondents and FDA. The system is currently undergoing additional beta testing and implementation is anticipated for summer 2005.
FDA estimates the annual burden of this collection of information as follows:
|21 CFR Section||Form No.||No. of Respondents||Annual Frequency per Response||Total Annual Responses||Hours per Response||Total Hours|
|720.1 through 720.4 (new submissions)||FDA 2512 and FDA 2512a||112||12.9||1,446||0.5||723|
|720.4 and 720.6 (amendments)||FDA 2512 and FDA 2512a||112||0.5||52||0.33||17|
|720.3 and 720.6 (notices of discontinuance)||FDA 2514||112||1||4||0.1||0.4|
|720.8 (requests for confidentiality)||1||1||1||1.5||1.5|
|1 There are no capital costs or operating and maintenance costs associated with this collection of information.|
These estimates are based on FDA's experience with the Cosmetic Product Voluntary Reporting Program. The estimated annual total hour burden is 75 percent of the burden reported in 2002 due to decreased submissions. However, the number of respondents doubled, and FDA attributes this to increased interest in the program. FDA expects the number of submissions to increase accordingly in the next 3 years.Start Signature
Dated: June 6, 2005.
Assistant Commissioner for Policy.
[FR Doc. 05-11641 Filed 6-10-05; 8:45 am]
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