[Federal Register Volume 64, Number 161 (Friday, August 20, 1999)]
[Notices]
[Pages 45554-45555]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-21581]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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


Agency Information Collection Activities; Submission for OMB 
Review; 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 that the 
proposed collection of information listed below has 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 collection of information by 
September 20, 1999.

ADDRESSES: Submit written comments on the collection 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: 
Wendy Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Peggy Schlosburg, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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.
     In the Federal Register of June 4, 1999 (64 FR 30037), the agency 
requested comments on the proposed collections of information. One 
comment was received that was supportive of the proposal and encouraged 
FDA to continue this information collection request.
     FDA estimates the burden of this collection of information as 
follows:

                                 Table  1.--Estimated Annual Reporting Burden\1\
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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.


[[Page 45555]]

     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: August 16, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning and Legislation.
[FR Doc. 99-21581 Filed 8-19-99; 8:45 am]
BILLING CODE 4160-01-F