[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
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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
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Total
No. of Annual Total Annual Hours per Operating and
Respondent Respondents Frequency per Responses Response Total Hours Maintenance
Response Costs
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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
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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
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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
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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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101.69(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 ? ?
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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 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