[Federal Register: November 28, 2000 (Volume 65, Number 229)]
[Notices]
[Page 70917-70918]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28no00-115]
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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