[Federal Register Volume 73, Number 116 (Monday, June 16, 2008)]
[Pages 34024-34025]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-13522]



Food and Drug Administration

[Docket No. FDA-2008-N-0132]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; State Petitions for 
Exemption From Preemption

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by July 
16, 2008.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-6974, or e-mailed to [email protected]. All comments 
should be identified with the OMB control number 0910-0277. Also 
include the FDA docket number found in brackets in the heading of this 

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief 
Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4659.

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 No. 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 

[[Page 34025]]

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 satisfies the criteria of 
section 403A(b) of the act for granting exemption from Federal 
    In the Federal Register of March 4, 2008 (73 FR 11648), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.

                                 Table 1.--Estimated Annual Reporting Burden\1\
                         No. of        Annual Frequency     Total Annual        Hours per
  21 CFR Section      Respondents        per Response        Responses           Response         Total Hours
100.1(d)                           1                  1                  1                 40                 40
\1\ There are no capital costs or operating and maintenance costs associated with this collection of

    The reporting burden for Sec.  100.1(d) is minimal because 
petitions for exemption from preemption are seldom submitted by States. 
In the last 3 years, FDA has not received any new petitions for 
exemption from preemption; therefore, the agency estimates that one or 
fewer petitions will be submitted annually. Although FDA has not 
received any new petitions for exemption from preemption in the last 3 
years, 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 403(A) of the act.

    Dated: June 10, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-13522 Filed 6-13-08; 8:45 am]