[Federal Register Volume 61, Number 105 (Thursday, May 30, 1996)]
[Notices]
[Pages 27083-27085]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-13536]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0122]-


Agency Information Collection Activities: Proposed Collections; 
Comment Request; Extension/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, 
Federal agencies are required to publish a notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension or reinstatement of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on reporting requirements 
contained in existing FDA regulations governing temporary marketing 
permit applications, State petitions for exemption from preemption, 
State enforcement notifications, and reference amount petitions.

DATES: Submit written comments on the collections of information by 
July 29, 1996.

ADDRESSES: Submit written comments on the collections 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: Charity B. Smith, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, rm. 16B-19, Rockville, MD 20857, 
301-827-1686.

SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork 
Reduction Act of 1995 (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 or reinstatement of an existing collection of information. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c). To comply with this requirement, FDA is publishing notice of 
the proposed collections of information listed below.
    With respect to each of the following collections of information, 
FDA invites comments on: (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.

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

    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:

[[Page 27084]]



                                                       TABLE 1.--ESTIMATED ANNUAL REPORTING BURDEN                                                      
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   21 CFR Section         No. of Respondents      Annual Frequency per Response  Total Annual Responses      Hours per Response          Total Hours    
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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:

                                                       TABLE 2.--ESTIMATED ANNUAL REPORTING BURDEN                                                      
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   21 CFR Section         No. of Respondents      Annual Frequency per Response  Total Annual Responses      Hours per Response          Total Hours    
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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 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:

                                                       TABLE 3.--ESTIMATED ANNUAL REPORTING BURDEN                                                      
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   21 CFR Section         No. of Respondents      Annual Frequency per Response  Total Annual Responses      Hours per Response          Total Hours    
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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 Sec. 101.9(b) (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

[[Page 27085]]

petitioner is required to include in the petition.
    FDA estimates the burden resulting from the requirements of 
Sec. 101.12(h) as follows:

                                                       TABLE 4.--ESTIMATED ANNUAL REPORTING BURDEN                                                      
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                                              Annual Frequency per         Total Annual                                                Total Operating &
 21 CFR Section      No. of Respondents             Response                Responses          Hours per Response      Total Hours     Maintenance Costs
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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: May 22, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-13536 Filed 5-29-96; 8:45 am]
BILLING CODE 4160-01-F