[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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
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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: 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
