[Federal Register Volume 62, Number 170 (Wednesday, September 3, 1997)]
[Notices]
[Pages 46500-46501]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-23246]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0353]
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 (the PRA).
DATES: Submit written comments on the collection of information by
October 3, 1997.
ADDRESSES: Submit written comments on the collection of information to
Office of Information and Regulatory Affairs, OMB, New Executive Office
Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attention:
Desk Officer for FDA.
FOR FURTHER INFORMATION CONTACT: Margaret R. Wolff, Office of
Information Resources Management (HFA-250), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.
SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the PRA
(44 U.S.C. 3507), FDA has submitted the following proposed collection
of information to OMB for review and clearance:
Food Additives and Food Additive Petitions (21 CFR Parts 171, 172,
173, 175 to 178, and 180) (OMB Control Number 0910-0016--
Reinstatement)
Section 409(a) of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 348(a)) provides that any particular use or intended
use of a food additive shall be deemed to be unsafe, unless the
additive and its use or intended use are in conformity with a
regulation issued under section 409 of the act that describes the
condition(s) under which the additive may be safely used, or unless the
additive and its use or intended use conform to the terms of an
exemption for investigational use. Food additive petitions are
submitted by individuals or companies to obtain approval of a new food
additive or to amend the conditions of use permitted under an existing
food additive regulation. Section 171.1 (21 CFR 171.1)
[[Page 46501]]
specifies the information that a petitioner must submit in order to
establish that the proposed use of a food additive is safe and to
secure the publication of a food additive regulation describing the
conditions under which the additive may be safely used. Parts 172, 173,
175 to 178, and 180 (21 CFR parts 172, 173, 175 to 178, and 180)
contain labeling requirements for certain food additives to ensure
their safe use.
FDA scientific personnel review food additive petitions to ensure
the safety of the intended use of the food additive in or on food, or
of a food additive that may be present in food as a result of its use
in articles that contact food. FDA requires food additive petitions to
contain the information specified in Sec. 171.1 in order to determine
whether a petitioned use for a food additive is safe, as required by
the act. This regulation (Sec. 171.1) implements section 409(b)(2) of
the act.
Respondents are businesses engaged in the manufacture or sale of
food, food ingredients, or substances used in materials that come into
contact with food.
FDA estimates the burden of complying with the information
collection provisions of the agency's food additive petition
regulations as follows:
Table 1. -- Estimated Annual Reporting Burden
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Annual
21 CFR No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
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171.1 44 1 44 2,876 126,560
Part 172 44 1 44 0 0
Part 173 44 1 44 0 0
Parts 175 to 178 44 1 44 0 0
Part 180 44 1 44 0 0
Total 44 126,560
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There are no capital costs or operating and maintenance costs associated with this collection.
This estimate is based on the average number of new food additive
petitions received in fiscal year 1995 and the total hours expended by
petitioners to prepare the petitions. The burden varies with the
complexity of the petition submitted, because food additive petitions
involve the analysis of scientific data and information, as well as the
work of assembling the petition itself. Because labeling requirements
under parts 172, 173, 175 to 178, and 180 for particular food additives
involve information required as part of the food additive petition
safety review process under Sec. 171.1, the estimate for the number of
respondents is the same and the burden hours for labeling are included
in the estimate for Sec. 171.1.
Dated: August 26, 1997.
William B. Schultz,
Deputy Commissione for Policy.
[FR Doc. 97-23246 Filed 9-2-97; 8:45 am]
BILLING CODE 4160-01-F
