[Federal Register Volume 73, Number 119 (Thursday, June 19, 2008)]
[Notices]
[Pages 34940-34941]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-13818]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0170]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Premarket
Notification for a New Dietary Ingredient
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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 July
21, 2008.
ADDRESSES: 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: FDA Desk Officer,
FAX: 202-395-6974, or e-mailed to [email protected]. All comments
should be identified with the OMB control number 0910-0330. Also
include the FDA docket number found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief
Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-4659.
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.
Premarket Notification for a New Dietary Ingredient--(OMB Control
Number 0910-0330)--Extension
Section 413(a) of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 350b(a)) provides that at least 75 days before the
introduction or delivery for introduction into interstate commerce of a
dietary supplement that contains a new dietary ingredient, a
manufacturer or distributor of dietary supplements or of a new dietary
ingredient is to submit to FDA (as delegate for the Secretary of Health
and Human Services) information upon which the manufacturer or
distributor has based its conclusion that a dietary supplement
containing a new dietary
[[Page 34941]]
ingredient will reasonably be expected to be safe. Part 190 (21 CFR
part 190) implements these statutory provisions. Section 190.6(a)
requires each manufacturer or distributor of a dietary supplement
containing a new dietary ingredient, or of a new dietary ingredient, to
submit to the Office of Nutrition, Labeling, and Dietary Supplements
notification of the basis for their conclusion that said supplement or
ingredient will reasonably be expected to be safe. Section 190.6(b)
requires that the notification include the following: (1) The complete
name and address of the manufacturer or distributor, (2) the name of
the new dietary ingredient, (3) a description of the dietary
supplements that contain the new dietary ingredient, and (4) the
history of use or other evidence of safety establishing that the
dietary ingredient will reasonably be expected to be safe.
The notification requirements described previously are designed to
enable FDA to monitor the introduction into the food supply of new
dietary ingredients and dietary supplements that contain new dietary
ingredients, in order to protect consumers from unsafe dietary
supplements. FDA uses the information collected under these regulations
to help ensure that a manufacturer or distributor of a dietary
supplement containing a new dietary ingredient is in full compliance
with the act.
In the Federal Register of March 26, 2008 (73 FR 16020), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
Table 1.--Estimated Annual Reporting Burden\1\
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No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per Response Responses Response Total Hours
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190.6 71 1 71 20 1,420
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
The agency believes that there will be minimal burden on the
industry to generate data to meet the requirements of the premarket
notification program because the agency is requesting only that
information that the manufacturer or distributor should already have
developed to satisfy itself that a dietary supplement containing a new
dietary ingredient is in full compliance with the act. However, the
agency estimates that extracting and summarizing the relevant
information from the company's files and presenting it in a format that
will meet the requirements of section 413 of the act will require a
burden of approximately 20 hours of work per submission.
The estimated number of premarket notifications and hours per
response is an average based on the agency's experience with
notifications received during the last 3 years (i.e., 2005, 2006, and
2007), and information from firms that have submitted recent premarket
notifications.
Dated: June 13, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-13818 Filed 6-18-08; 8:45 am]
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