[Federal Register: April 8, 2005 (Volume 70, Number 67)]
[Page 18029-18030]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2004N-0565]

Agency Information Collection Activities; Submission for Office 
of Managment 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 May 9, 

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that comments be faxed to the 
Office of Information and Regulatory Affairs, OMB, Attn: Fumie

[[Page 18030]]

Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management 
Programs (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 
satisfies the criteria of section 403A(b) of the act for granting 
exemption from Federal preemption.
    In the Federal Register of January 13, 2005 (70 FR 2412), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. One comment was received. The comment expresses 
concern that it is unnecessary for FDA to maintain a ``program'' 
whereby States may petition the FDA to request exemption from 
preemption because States are not asking for exemptions. The comment 
asserts that the ``program'' wastes taxpayer dollars and suggests that 
FDA abolish it.
    Under section 403A(b) of the act, States may petition FDA for 
exemption from Federal preemption of State food labeling and standard-
of-identity requirements. FDA's regulations at Sec.  100.1(d), the 
subject matter of this information collection, set forth the 
information a State is required to submit in such a petition. Section 
100.1(d) implements a statutory information collection requirement. 
Therefore, FDA cannot abolish the regulations unless the statute is 
    FDA estimates the burden of the collection of information as 

                                                     Table 1.--Estimated Annual Reporting Burden\1\
                                                                               Annual Frequency per     Total Annual      Hours per
                 21 CFR Section                      No. of Respondents              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 information.

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

    Dated: April 1, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-7022 Filed 4-7-05; 8:45 am]