[Federal Register Volume 65, Number 229 (Tuesday, November 28, 2000)]
[Notices]
[Pages 70917-70918]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-30330]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 95N-0220]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Substances Approved for Use in the Preparation 
of Meat and Poultry Products

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 
December 28, 2000.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Wendy Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Peggy Schlosburg, 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 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Petition for Approval of Substances for Use in the Preparation of 
Meat and Poultry Products--21 CFR 71.1 and 171.1

    Sections 409 and 721 of the Federal Food, Drug, and Cosmetic Act 
(the act) (21 U.S.C. 348 and 379e) require FDA to evaluate the safety 
and regulate the use of food and color additives used as ingredients in 
or on all foods. These sections also authorize FDA to accept petitions 
for approval of food and color additives. The Federal Meat Inspection 
Act and the Poultry Products Inspection Act (21 U.S.C. 601(m)(2) and 
453(g)(2), respectively) authorize the administration of the Food 
Safety and Inspection Service (FSIS), U.S. Department of Agriculture to 
determine the suitability of the use of a substance in meat and poultry 
products. Regulations of the two agencies regarding petition 
submissions at times include conditions, formats, and terms that are 
not fully consistent with one another because of the different 
statutory mandates. Under the current process, FDA and FSIS conduct 
separate, sequential reviews of petitions, each agency applying its 
respective

[[Page 70918]]

procedures to ascertain that a substance is lawful for the use intended 
in or on products containing meat or poultry.
    When petitioning for approval for the use of substances in meat and 
poultry products, the applicants must provide four copies of the 
petition to FDA, rather than the three copies as currently specified in 
Secs. 71.1 and 171.1 (21 CFR 71.1 and 171.1). FDA will then forward a 
copy of the petition or relevant portions of the petition to FSIS so 
that both agencies can perform the necessary reviews simultaneously, 
thus reducing the time it takes to authorize an ingredient for use in 
meat and poultry products. The petitioners are not required to submit 
any new information to either FDA or FSIS.
    This regulation results from a coordinated effort by the two 
agencies to ease the paperwork burden on regulated industries through 
streamlining the Federal Government's food ingredient approval process 
for substances used in meat and poultry products.
    Description of Respondents: Businesses or other for profit.
    In the Federal Register of August 25, 2000 (65 FR 51758), the 
agency requested comments on the proposed collection of information. No 
comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                         Table 1.--Estimated Annual Increase in Reporting Hour Burden\1\
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                                                      Annual                        Increase in
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per    Total Increase
                                    Respondents      Response        Responses       Response        in Hours
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71.1 and 171.1                         10               1              10               2             20
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on FDA's past experience with food and color additive 
petitions and on discussions with FSIS about its past experience, it 
will receive 10 petitions annually that request approval for use of a 
substance in meat and poultry products. Submission of a petition for 
the use of a substance in meat and poultry products is a one-time 
event. FDA estimates that the respondent would expend 2 hours to make a 
fourth photocopy of the petition, necessary for FDA to send to FSIS to 
conduct a simultaneous review. FDA, therefore, estimates that the total 
burden of data collection under Secs. 71.1 and 171.1 will increase by 
20 hours per year because of the requirement to submit a fourth copy of 
petitions when a substance is to be used in meat or poultry products.

    Dated: November 20, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-30330 Filed 11-27-00; 8:45 am]
BILLING CODE 4160-01-F