[Federal Register Volume 61, Number 244 (Wednesday, December 18, 1996)]
[Notices]
[Pages 66671-66673]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32034]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0373]


Agency Information Collection Activities: Proposed Collection; 
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 proposed collections of certain 
information by the agency. Under the Paperwork Reduction Act of 1995, 
Federal agencies are required to publish 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 the maintenance of lists of 
U.S. processors that export certain animal-derived foods (i.e., shell 
eggs, dairy products, game meat, and game meat products) to the 
European Community (EC), temporary exemptions from certain food 
labeling requirements for the purpose of conducting authorized food 
labeling experiments, petitions for health claims, and petitions for 
nutrient content claims.

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

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: Kimberly 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 Paperwork Reduction Act of 1995 
(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 or reinstatement of an existing collection of information, 
before submitting the collection to OMB for approval. 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. Request for Information From U.S. Processors that Export to the 
European Community (OMB Control Number 0910-0320--Reinstatement)

    EC is a group of 15 European countries that have agreed to 
harmonize their commodity requirements to facilitate commerce among 
member States. EC legislation for intra-EC trade has been extended to 
trade with non-EC countries, including the United States. For certain 
food products, including those listed below, EC legislation requires 
assurances from the responsible authority of the country of origin that 
the processor of the food is in compliance with applicable regulatory 
requirements.
    With the assistance of trade associations and State authorities, 
FDA intends to request information from processors that export certain 
animal-derived products (shell eggs, dairy products, game meat, and 
game meat products) to EC. FDA will use the information to maintain 
lists of processors that have demonstrated current compliance with U.S. 
requirements and will provide the lists to EC quarterly. Inclusion on 
the list is voluntary. EC member countries will refer to the lists at 
ports of entry to verify that products offered for importation to EC 
from the United States are from processors that meet U.S. regulatory 
requirements. Products processed by firms not on the processor list are 
subject to detention and possible refusal at the port. FDA intends to 
request the following information from each processor:
    (1)  Business name and address;
    (2)  Name and telephone number of person designated as business 
contact;
    (3)  Lists of products presently being shipped to EC and those 
intended to be shipped in the next 6 months;
    (4)  Name and address of manufacturing plants for each product;
    (5)  Names and affiliations of any Federal, State, or local 
governmental agencies that inspect the plant, government-assigned plant 
identifier, such as plant number, and last date of inspection; and
    (6)  Assurance that the firm or individual representing the firm 
and

[[Page 66672]]

submitting a certificate for signature to FDA is aware of and knows 
that they are subject to the provisions of Section 1001 of Title 18, 
United States Code. This law provides that it is a criminal offense to 
knowingly and willfully make a false statement or alter or counterfeit 
documents in a matter within the jurisdiction of a U.S. agency.
    FDA estimates the burden of this collection of information as 
follows:

                                   Table 1.--Estimated Annual Reporting Burden                                  
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                                                      Annual                                                    
            Products                  No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                    Respondents      Response        Responses       Response                   
----------------------------------------------------------------------------------------------------------------
Shell Eggs                             50               1              50               0.25           12.50    
Dairy                                 250               1             250               0.25           62.50    
Game Meat and Game Meat Products       75               1              75               0.25           18.75    
Total                                 375               1             375               0.25           93.75    
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There are no capital costs or operating and maintenance costs associated with this collection.                  

    The burden estimate is based on the time needed to write and 
transmit information which is readily available to the respondents. The 
number of respondents is based on prior responses to a request for this 
information.
    Third Party Disclosure

                                   Table 2.--Estimated Annual Reporting Burden                                  
----------------------------------------------------------------------------------------------------------------
                                                                                                       Total    
                      No. of          Annual       Total Annual      Hours per                     Operating and
   Respondent       Respondents    Frequency per     Responses       Response       Total Hours     Maintenance 
                                     Response                                                          Costs    
----------------------------------------------------------------------------------------------------------------
Trade                                                                                                           
 Association           14               1              14               8             112          $7,000       
State                  50               1              50               8             400          $2,500       
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There are no capital costs associated with this collection.                                                     

    The burden estimated for the trade associations assumes the trade 
associations will disseminate FDA's information request through mass 
mailings to their membership or publish it in their trade magazine or 
newsletter. The burden estimated for State authorities assumes 
dissemination of information to the processors or dissemination of 
information about the processors to FDA.


2. Exemptions Petitions for the Conduct of Food Labeling Experiments--
21 CFR 101.108 (OMB Control No. 0910-0151--Reinstatement)

    Under the authority of section 403(q) of the Federal Food, Drug, 
and Cosmetic Act (the act) (21 U.S.C. 343(q)), FDA issued requirements 
for the declaration of nutrition information on food labels and 
labeling, including Sec. 101.9 (21 CFR 101.9). Section 101.9 prescribes 
the format, including graphics and style, as well as alternative 
approaches, that are to be used by food producers in presenting 
nutrition information on the labels and labeling of their food 
products. FDA provides authorization in Sec. 101.108 (21 CFR 101.108), 
in the form of temporary exemptions, for food producers to experiment 
with graphics and other formats for presenting nutrition and other 
related food labeling information. The information required under 
Sec. 101.108(b) is needed to monitor the labeling of experimental packs 
of food deviating from the requirements of nutrition labeling. The 
information obtained in these experiments can be used in support of 
petitions to amend the nutrition labeling regulations to provide for 
the variations. The respondents for this collection are businesses or 
other for-profit organizations.
    FDA estimates the burden of this collection of information as 
follows:

                                   Table 3.--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                   
----------------------------------------------------------------------------------------------------------------
101.108                                 0               1               0              40               0       
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There are no capital costs or operating and maintenance costs associated with this collection.                  

    The reporting burden for Sec. 101.108 is insignificant because 
exemption petitions are seldom submitted for the conduct of food 
labeling experiments. Over the last 3 years, FDA has not received any 
exemption petitions. Since the regulation was originally adopted on 
April 8, 1983, FDA has received only a few requests for temporary 
exemptions for the purposes of conducting authorized food labeling 
experiments.


3. Petitions for Health Claims--21 CFR 101.70(f) (OMB Control No. 0910-
0287--Reinstatement)

    Section 403(r)(4) of the act provides for the submission of 
petitions to FDA requesting the issuance of a regulation authorizing a 
health claim on a substance-disease relationship. Section

[[Page 66673]]

101.70(f) (21 CFR 101.70(f)) sets forth the information a person is 
required to supply in such a petition. This information will be used by 
the agency in determining whether a petition meets the requirements for 
issuing a regulation authorizing a health claim, thereby ensuring that 
the public health is protected. The respondents for this collection are 
businesses, other for-profit organizations, or not-for-profit 
organizations.
    FDA estimates the burden of this collection of information as 
follows:

                                                       Table 4.--Estimated Annual Reporting Burden                                                      
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                               Total    
                                              No. of          Annual       Total Annual      Hours per                     Total Capital   Operating and
             21 CFR Section                 Respondents    Frequency per     Responses       Response       Total Hours        Costs        Maintenance 
                                                             Response                                                                          Costs    
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101.70(f)                                       3               1               3              80             240               ?               ?       
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Where question marks (?) appear, FDA has no information on which to determine whether there are capital costs or operating and maintenance costs        
  associated with this collection. FDA is asking for comments on the extent to which there are capital costs or operating and maintenance costs         
  associated with this collection.                                                                                                                      

    FDA has estimated the average costs and burdens above based on its 
experience with health claim petitions that have been submitted to the 
agency. In the more than 3 years since Sec. 101.70(f) became effective, 
FDA has received less than 10 health claims petitions. The hour burden 
is based on FDA's estimate of the average amount of time required to 
prepare these petitions.


4. Petitions for Nutrient Content Claims--21 CFR 101.69(m), (n), and 
(o) (OMB Control No. 0910-0288--Reinstatement)

    Section 403(r)(4) of the act provides for the submission of 
petitions to FDA requesting the issuance of regulations authorizing a 
nutrient content claim characterizing the amount of a nutrient in a 
food product. Section 101.69(m)(1), (n)(1), and (o)(1) (21 CFR 
101.69(m)(1), (n)(1), and (o)(1)) sets forth data requirements specific 
for nutrient content claims petitions, synonym petitions, and brand-
name petitions, respectively. This information is used by FDA in 
determining whether a petition meets the requirements of the 
regulations for the issuance of a regulation providing for a nutrient 
content claim. The respondents for this collection are businesses, 
other for-profit organizations, or not-for-profit organizations.
    FDA estimates the burden of this collection of information as 
follows:

                                                       Table 5.--Estimated Annual Reporting Burden                                                      
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                               Total    
                                              No. of          Annual       Total Annual      Hours per                     Total Capital   Operating and
             21 CFR Section                 Respondents    Frequency per     Responses       Response       Total Hours        Costs        Maintenance 
                                                             Response                                                                          Costs    
--------------------------------------------------------------------------------------------------------------------------------------------------------
101.69(m)(1)                                    1               1               1              40              40               ?               ?       
101.69(n)(1)                                    1               1               1              20              20               ?               ?       
101.69(o)(1)                                    1               1               1              20              20               ?               ?       
Totals                                                                                                         80               ?               ?       
--------------------------------------------------------------------------------------------------------------------------------------------------------
Where question marks (?) appear, FDA has no information on which to determine whether there are capital costs or operating and maintenance costs        
  associated with this collection. FDA is asking for comments on the extent to which there are capital costs or operating and maintenance costs         
  associated with this collection.                                                                                                                      

    FDA has estimated the average costs and burdens above based on its 
experience with nutrient content claim petitions that have been 
submitted to the agency. In the more than 2 years since Sec. 101.69(m), 
(n), and (o) became effective, FDA has received only one nutrient 
content claim petition under Sec. 101.69(n). The hour burden is based 
on FDA's estimate of the average amount of time required to prepare 
that petition. The hour burden for Sec. 101.69(m) and (o) is based on 
the assumption that one petition would be submitted under each 
provision and that the information requirements are more complex 
(Sec. 101.69(m)) or about the same (Sec. 101.69(o)) as for 
Sec. 101.69(n)).

    Dated: December 11, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-32034 Filed 12-17-96; 8:45 am]
BILLING CODE 4160-01-F