[Federal Register: September 14, 2005 (Volume 70, Number 177)]
[Page 54393-54394]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2005N-0186]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; State Enforcement 

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 October 
14, 2005.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. 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: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management 
Programs (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 

    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 
    In the Federal Register of June 20, 2005 (70 FR 35446), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. FDA received no comments.
    FDA estimates the burden of this collection of information as 

[[Page 54394]]

                                 Table 1.--Estimated Annual Reporting Burden\1\
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
100.2(d)                                       1               1               1              10              10
\1\ There are no capital costs or operating and maintenance costs associated with this collection of

    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: September 7, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-18223 Filed 9-13-05; 8:45 am]