[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
