[Federal Register Volume 61, Number 210 (Tuesday, October 29, 1996)]
[Notices]
[Pages 55807-55808]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-27747]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96N-0335]


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 collections of information listed below have 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 collections of information by 
November 29, 1996.
ADDRESSES: Submit written comments on the collections 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: 
Desk Officer for FDA.

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: In compliance with section 3507 of the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3507), FDA has submitted the 
following proposed collections of information to OMB for review and 
clearance:

1. Temporary Marketing Permit Applications (21 CFR 130.17(c) and 
(i)) (OMB Control Number 0910-0133--Reinstatement)

    Section 401 of the Federal Food, Drug, and Cosmetic Act (the act) 
(21 U.S.C. 341) directs FDA to issue regulations establishing 
definitions and standards of identity for food ``whenever * * * such 
action will promote honesty and fair dealing in the interest of 
consumers.'' Under section 403(g) of the act (21 U.S.C. 343(g)), a food 
that is subject to a definition and standard of identity prescribed by 
regulation is misbranded if it does not conform to such definition and 
standard of identity. Section 130.17 (21 CFR 130.17) provides for the 
issuance by FDA of temporary marketing permits that enable the food 
industry to test consumer acceptance and measure the technological and 
commercial feasibility in interstate commerce of experimental packs of 
food that deviate from applicable definitions and standards of 
identity. Section 130.17(c) specifies the information that a firm must 
submit to FDA to obtain a temporary marketing permit. The information 
required in a temporary marketing permit application under 
Sec. 130.17(c) enables the agency to monitor the manufacture, labeling, 
and distribution of experimental packs of food that deviate from 
applicable definitions or standards of identity. The information so 
obtained can be used in support of a petition to establish or amend the 
applicable definition or standard of identity to provide for the 
variations. Section 130.17(i) specifies the information that a firm 
must submit to FDA to obtain an extension of a temporary marketing 
permit.
    FDA estimates the burden of the temporary marketing permit 
application requirements as follows:

                                        Estimated Annual Reporting Burden                                       
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                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                    Respondents      Response        Responses       Response                   
----------------------------------------------------------------------------------------------------------------
130.17                                 15               1.33           20              11.5           230       
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There are no capital costs or operating and maintenance costs associated with this collection.                  

    The estimated number of temporary marketing permit applications and 
hours per response is an average based on the agency's experience with 
applications received from October 30, 1991, through September 30, 
1994.

2. State Petitions for Exemption From Preemption (21 CFR 100.1(d)) 
(OMB Control Number 0910-0277--Reinstatement)

    Under section 403A(b) of the act (21 U.S.C. 343-1(b)), States may 
petition FDA for exemption from Federal preemption of State food 
labeling and standard of identity requirements. Section 100.1(d) (21 
CFR 100.1(d)) sets forth the information a State is required to submit 
in such a petition. The information required under Sec. 100.1(d) 
enables FDA to determine whether the State food labeling or standard of 
identity requirement comports with the statutory criteria for exemption 
from Federal preemption.
    FDA estimates the burden resulting from the requirements of 
Sec. 100.1(d) as follows:

                                        Estimated Annual Reporting Burden                                       
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                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                    Respondents      Response        Responses       Response                   
----------------------------------------------------------------------------------------------------------------
100.1(d)                                5               1               5              40             200       
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There are no capital costs or operating and maintenance costs associated with this collection.                  

    Since the enactment of section 403A(b) of the act as part of the 
Nutrition Labeling and Education Act of 1990 (the 1990 amendments), FDA 
has received eight petitions for exemption from preemption. Based upon 
these submissions, FDA estimates that no more than five petitions will 
be submitted annually. Because Sec. 100.1(d) implements a statutory 
information collection requirement, only the additional burden 
attributable to the regulation has been included in the estimate.

3. State Enforcement Notification (21 CFR 100.2(d)) (OMB Control 
Number 0910-0275--Reinstatement)

    Section 310(b) of the act (21 U.S.C. 337(b)) authorizes States to 
enforce certain sections of the act in their own

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names, but provides that States must notify FDA before doing so. 
Section 100.2(d) (21 CFR 100.2(d)) sets forth the information that a 
State must provide to FDA in a letter of notification when it intends 
to take enforcement action under the act against a particular food 
located in the State. The information required under Sec. 100.2(d) will 
enable FDA to identify the food against which the State intends to take 
action and advise the State whether Federal action has been taken 
against it. With certain narrow exceptions, Federal enforcement action 
precludes State action under the act.
    FDA estimates the burden of complying with the enforcement 
notification requirement as follows:

                                        Estimated Annual Reporting Burden                                       
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                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                    Respondents      Response        Responses       Response                   
----------------------------------------------------------------------------------------------------------------
100.2(d)                                5               1               5               2              10       
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There are no capital costs or operating and maintenance costs associated with this collection.                  

    Based upon the small number of enforcement notifications received 
from the States since the enactment of section 310(b) of the act in 
1990, FDA estimates that no more than five notifications will be 
submitted annually. Because 21 CFR 100.21(d) implements a statutory 
information collection requirement, only the additional burden 
attributable to the regulation has been included in the estimate.

4. Reference Amount Petitions (21 CFR 101.12(h)) (OMB Control 
Number 0910-0286--Reinstatement)

    Section 403(q)(1)(A) of the act (21 U.S.C. 343(q)(1)(A)) requires 
that the label or labeling of food provide nutrition information that 
includes the serving size or, if the food is not typically expressed in 
a serving size, the common household unit of measure that expresses the 
serving size of the food. In response to section 2(b)(1)(B) of the 1990 
amendments, FDA issued regulations defining the serving size (or other 
unit of measure) for various types of food. Food producers are required 
to use the reference amount values provided in Sec. 101.12 (21 CFR 
101.12) and the rules for establishing serving sizes that are 
prescribed in 21 CFR 101.9(b) to determine the appropriate serving size 
for their products; however, a manufacturer or other interested person 
may submit a petition to establish or amend the reference amount value 
for a food or to create a new food subcategory with its own reference 
amount. Section 101.12(h) sets forth the information the petitioner is 
required to include in the petition.
    FDA estimates the burden resulting from the requirements of 
Sec. 101.12(h) as follows:

                                        Estimated Annual Reporting Burden                                       
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                                   Annual                                                                       
    21 CFR         No. of       Frequency per   Total Annual      Hours per      Total Hours   Total Operating &
   Section       Respondents      Response        Responses       Response                     Maintenance Costs
----------------------------------------------------------------------------------------------------------------
101.12(h)            5               1               5              80             400           $400,000       
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There are no capital costs associated with this collection.                                                     

    Since the enactment of the 1990 amendments that revised the act by 
adding section 403(q), FDA has received nine petitions to amend 
existing reference amounts. Based upon these submissions, FDA estimates 
that no more than five such petitions will be submitted annually. The 
estimate for operating and maintenance costs is based on the average 
cost of conducting a consumer survey to support a reference amount 
petition.

    Dated: October 23, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-27747 Filed 10-28-96; 8:45 am]
BILLING CODE 4160-01-F