[Federal Register Volume 77, Number 40 (Wednesday, February 29, 2012)]
[Notices]
[Pages 12308-12309]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-4776]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0797]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; State Enforcement
Notifications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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 March
30, 2012.
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 [email protected]. All
comments should be identified with the OMB control number 0910-0275.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Denver Presley, II, 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 Enforcement Notifications--21 CFR 100.2(d) (OMB Control Number
0910-0275)--Extension
Section 310(b) of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 337(b)) authorizes States to
[[Page 12309]]
enforce certain sections of the FD&C Act in their own names, but
provides that States must notify FDA before doing so. Section 100.2(d)
(21 CFR 100.2(d)) sets forth the information that a State must provide
to FDA in a letter of notification when it intends to take enforcement
action under the FD&C Act against a particular food located in the
State. The information required under Sec. 100.2(d) will enable FDA to
identify the food against which the State intends to take action and
advise the State whether Federal action has been taken against it. With
certain narrow exceptions, Federal enforcement action precludes State
action under the FD&C Act.
In the Federal Register of November 9, 2011 (76 FR 69742), 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\
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Number of
21 CFR Section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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100.2(d)........................ 1 1 1 10 10
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The estimated reporting burden for Sec. 100.2(d) is minimal
because enforcement notifications are seldom used by States. During the
last 3 years, FDA has not received any new enforcement notifications;
therefore, the Agency estimates that one or fewer notifications will be
submitted annually. Although FDA has not received any new enforcement
notifications in the last 3 years, it believes these information
collection provisions should be extended to provide for the potential
future need of a State government to submit enforcement notifications
informing FDA when it intends to take enforcement action under the FD&C
Act against a particular food located in the State.
Dated: February 23, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-4776 Filed 2-28-12; 8:45 am]
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