[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