[Federal Register: January 13, 2005 (Volume 70, Number 9)]
[Page 2412-2413]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2004N-0565]

Agency Information Collection Activities; Proposed Collection; 
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 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 or electronic comments on the collection of 
information by March 14, 2005.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Submit written comments on 

the collection of information to the Division of Dockets Management 
(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.

[[Page 2413]]

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: 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 these topics: (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 
satisfies the criteria of section 403A(b) of the act for granting 
exemption from Federal preemption.
    FDA estimates the burden of this collection of information as 

                                                     Table 1.--Estimated Annual Reporting Burden\1\
                                                                    Annual Frequency per     Total Annual
             21 CFR Section                 Number of Respondents         Response             Responses       Hours per 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, 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: January 7, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-674 Filed 1-12-05; 8:45 am]