[Federal Register Volume 61, Number 245 (Thursday, December 19, 1996)]
[Notices]
[Pages 67032-67033]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32125]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0374]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Reinstatement

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: 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 a 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 requirements relating to the 
approval and labeling of food additives.

DATES: Submit written comments on the collection of information by 
February 18, 1997.

ADDRESSES:  Submit written comments on the collection of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All comments should 
be identified with the docket number found in brackets in the heading 
of this document.

FOR FURTHER INFORMATION CONTACT:  Kim A. Sanders, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, rm. 16B-19, Rockville, MD 20857, 301-827-1473.

SUPPLEMENTARY 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 or 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

[[Page 67033]]

of the proposed collection of information listed below.
     With respect to the following collection of information, FDA 
invites comments on the following: (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.

Parts 171, 172, 173, 175-178, and 180 Food Additives and Food 
Additive Petitions (21 CFR Parts 171, 172, 173, 175-178, 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) 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, 175-178, 
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       
Part 175-178                           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, 175-178, 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: December 11, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-32125 Filed 12-18-96; 8:45 am]
BILLING CODE 4160-01-F