[Federal Register Volume 64, Number 107 (Friday, June 4, 1999)]
[Notices]
[Pages 30037-30038]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-14145]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-1393]


Agency Information Collection Activities: Proposed Collection; 
Comment Request; State Petitions for Exemption from Preemption

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 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information 
including each proposed extension 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 State petitions for 
exemption from preemption.

DATES: Submit written comments on the collection of information by 
August 3, 1990.

ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should 
be identified with the docket number found in brackets in the heading 
of this document.
FOR FURTHER INFORMATION CONTACT: Peggy R. Schlosburg, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: Under 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 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 collection 
of information set forth in this document.
     With respect to the following collection 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.

State Petitions for Exemption From Preemption (21 CFR 100.1(d)) 
(OMB Control Number 0910-0277--Extension)

     Under section 403A(b) of the Federal Food, Drug and Cosmetic Act 
(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 of this collection of information 
as follows:

[[Page 30038]]



                                  Table 1.--Estimated Annual Reporting Burden1
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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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 100.1(d)                               1               1               1              40              40
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

     The reporting burden for Sec. 100.1(d) is insignificant because 
petitions for exemption from preemption are seldom submitted by States 
requesting the agency grant an exemption from preemption by labeling 
requirements based upon certain sections of the act. Over the last 3 
years, FDA has not received any preemption petitions. Since the 
enactment of section 403A(b) of the act as part of the Nutrition 
Labeling and Education Act of 1990, FDA has received only eight 
petitions for seeking exemption from preemption. Although FDA believes 
that the burden will be insignificant, it believes these information 
collection provisions should be extended to provide for the potential 
future need of a State or local government to petition for an exemption 
from preemption under the provisions of section 403A(b) of the act.

    Dated: May 22, 1999.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 99-14145 Filed 6-3-99; 8:45 am]
BILLING CODE 4160-01-F