[Federal Register Volume 67, Number 154 (Friday, August 9, 2002)]
[Notices]
[Pages 51860-51861]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-20121]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0208]


Agency Information Collection Activities; Submission for OMB 
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 the 
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:  Submit written comments on the collection of information by 
September 9, 2002.

ADDRESSES:  Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Stuart Shapiro, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Peggy Schlosburg, Office of 
Information Resources Management (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 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 
act) (21 U.S.C. 337(b)) authorizes States to enforce certain sections 
of the 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 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 
act.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 51861]]



                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                      Annual Frequency per
     21 CFR Section          No. of Respondents             Response           Total Annual Responses      Hours per Response          Total Hours
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             1002(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 reporting burden for Sec. 100.2(d) is insignificant because 
enforcement notifications are seldom used by States. During the last 3 
years, FDA has not received any enforcement notifications. Since the 
enactment of section 403A(b) of the act (21 U.S.C. 343-1(b)) as part of 
the Nutrition Labeling and Education Act of 1990, FDA has received only 
a few enforcement notifications. 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 government to submit enforcement notifications informing FDA 
when it intends to take enforcement action under the act against a 
particular food located in the State.

    Dated: August 2, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-20121 Filed 8-8-02; 8:45 am]
BILLING CODE 4160-01-S