[Federal Register Volume 70, Number 117 (Monday, June 20, 2005)]
[Notices]
[Pages 35446-35447]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-12055]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0186]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; State Enforcement Notifications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on reporting requirements 
contained in existing FDA regulations governing State enforcement 
notifications.

DATES: Submit written or electronic comments on the collection of 
information by August 19, 2005.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments. Submit written comments on 
the collection of information to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

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: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

[[Page 35447]]

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:

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                                         Annual Frequency per    Total Annual      Hours Per
 21 CFR Section    No. of Respondents          Response           Responses         Response       Total Hours
----------------------------------------------------------------------------------------------------------------
100.2(d)                            1                      1                1               10               10
----------------------------------------------------------------------------------------------------------------
\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: June 14, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-12055 Filed 6-17-05; 8:45 am]
BILLING CODE 4160-01-S