[Federal Register Volume 61, Number 176 (Tuesday, September 10, 1996)] [Notices] [Page 47756] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 96-23098] [[Page 47756]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 96N-0222] Agency Information Collection Activities; Submission for OMB Review; Comment Request
Agency
Food and Drug Administration, HHS.
Action
Notice.
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Summary
The Food and Drug Administration (FDA) is announcing that the proposed collection of information listed below 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 on the collection of information by October 10, 1996.
Addresses
Submit written comments on the collection of information to the Office of Information and Regulatory Affairs, OMB, New Executive Office Bldg., rm. 10235, 725 17th St. NW., Washington, DC 20503, Attention: Desk Officer for FDA.
For Further Information Contact
Charity B. Smith, Office of Information Resources Management (HFA-250), Food and Drug Administration, 5600 Fishers Lane, rm. 16B-19, Rockville, MD 20857, 301-827-1686.
Supplementary Information
In compliance with section 3507 of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), FDA has submitted the following proposed collection of information to OMB for review and clearance: Secs. 70.25 Labeling requirements for color additives (other than hair dyes) (21 CFR 70.25) and 71.1 Petitions (21 CFR 71.1) (OMB Control Number 0910-0185--Reinstatement). Section 721(a) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 379e) provides that a color additive shall be deemed to be unsafe unless the additive and its use are in conformity with a regulation that describes the condition(s) under which the additive may safely be used, or unless the additive and its use conform to the terms of an exemption for investigational use issued under section 721(f) of the act. Color additive petitions are submitted by individuals or companies to obtain approval of a new color additive or a change in the conditions of use permitted for a color additive that is approved already. Section 71.1 specifies the information that a petitioner must submit in order to establish the safety of a color additive and to secure the issuance of a regulation permitting its use. FDA scientific personnel review color additive petitions to ensure that the intended use of the color additive in or on food, drugs, cosmetics, and medical devices is suitable and safe. Color additive petitions were specifically provided for by Congress when it enacted the Color Additive Amendments of 1960 (Pub. L. 94-295). If FDA stopped accepting color additive petitions or stopped requiring them to contain the information specified in Sec. 71.1, the number of new color additives approved would decrease. FDA's color additive labeling requirements in Sec. 70.25 require that color additives that are to be used in foods, drugs, devices, or cosmetics be labeled with sufficient information to ensure their safe use. FDA estimates the burden of complying with the information collection provisions of the agency's color additive regulations as follows:
Estimated Annual Reporting Burden ---------------------------------------------------------------------------------------------------------------- Total No. of Annual Total Annual Hours Total Operating & 21 CFR Section Respondents Frequency per Responses per Hours Maintenance Response Response Costs ---------------------------------------------------------------------------------------------------------------- 70.25.......................... 2 1 2 71.1........................... 2 1 2 1,700 3,415 $6,000 Total...................... 2 3,415 $6,000 ---------------------------------------------------------------------------------------------------------------- There are no capital costs associated with this collection.
This estimate is based on the number of new color additive petitions received in 1994. Although the burden varies with the type of petition submitted, a color additive petition involves analytical work and appropriate toxicology studies, as well as the work of drafting the petition itself. Because labeling requirements under Sec. 70.25 for a particular color additive involve information required as part of the color additive petition safety review process, the estimate for number respondents is the same for Sec. 70.25 as for Sec. 71.1, and the burden hours for labeling are included in the estimate for Sec. 71.1.
Dated: September 3, 1996. William K. Hubbard, Associate Commissioner for Policy Coordination. [FR Doc. 96-23098 Filed 9-9-96; 8:45 am] BILLING CODE 4160-01-F