
[Federal Register Volume 79, Number 204 (Wednesday, October 22, 2014)]
[Notices]
[Pages 63128-63129]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-25106]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1104]


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 
November 21, 2014.

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: 202-395-7285, or emailed to oira_submission@omb.eop.gov. 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 document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd.; COLE-14526, Silver 
Spring, MD 20993-0002 PRAStaff@fda.hhs.gov.

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 FD&C 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

[[Page 63129]]

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 FD&C Act for granting exemption from 
Federal preemption.
    In the Federal Register of August 7, 2014 (79 FR 46269), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the annual burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                  Number of
                     21 CFR 100.1(d)                           Number of        responses per       Total annual     Avg. burden per      Total hours
                                                              respondents         respondent         responses           response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Form of petition.........................................                 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 minimal because 
petitions for exemption from preemption are seldom submitted by states. 
In the last 3 years, we have received one new petition for exemption 
from preemption; therefore, we estimate that one or fewer petitions 
will be submitted annually.

    Dated: October 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-25106 Filed 10-21-14; 8:45 am]
BILLING CODE 4164-01-P


