[Federal Register Volume 64, Number 163 (Tuesday, August 24, 1999)]
[Notices]
[Pages 46204-46205]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-21853]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-1392]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; State Enforcement Notification

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 listed below 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 23, 1999.

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: 
Wendy Taylor, 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 Notification--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.
     In the Federal Register of June 8, 1999 (64 FR 30525), the agency 
requested comments on the proposed collections of information. No 
comments were received.
     FDA estimates the burden of this collection of information as 
follows:

[[Page 46205]]



                                 Table  1.--Estimated Annual Reporting Burden\1\
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                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       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 reporting burden for Sec. 100.2(d) is insignificant because 
enforcement notifications are seldom submitted by States requesting the 
agency take enforcement action under the act against a particular food. 
Over 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 obligation of a State to notify FDA of 
an enforcement action under the provisions of section 310(b) of the 
act.

    Dated: August 18, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning and Legislation.
[FR Doc. 99-21853 Filed 8-23-99; 8:45 am]
BILLING CODE 4160-01-F