[Federal Register Volume 76, Number 160 (Thursday, August 18, 2011)]
[Notices]
[Pages 51373-51374]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-21041]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0402]
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
September 19, 2011.
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 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 document.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3793.
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 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 June 10, 2011 (76 FR 34082), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
21 CFR section Number of responses per Total annual burden per Total hours
respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
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 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
[[Page 51374]]
government to petition for an exemption from preemption under the
provisions of section 403A of the FD&C Act.
Dated: August 12, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-21041 Filed 8-17-11; 8:45 am]
BILLING CODE 4160-01-P