[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
