[Federal Register: May 3, 2005 (Volume 70, Number 84)]
[Notices]
[Page 22886-22887]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03my05-64]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0031]
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 June 2,
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.
Premarket Notification for a New Dietary Ingredient--21 CFR 190.6 (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 a manufacturer or distributor of
dietary supplements or of a new dietary ingredient is to submit
information to FDA (as delegate for the Secretary of Health and Human
Services) upon which it has based its conclusion that a dietary
supplement containing a new dietary ingredient will reasonably be
expected to be safe at least 75 days before the introduction or
delivery for introduction into interstate commerce of a dietary
supplement that contains a new dietary ingredient. FDA's regulations at
part 190, subpart B (21 CFR part 190, subpart B) implement 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
Nutritional Products, 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 contains
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 February 7, 2005 (70 FR 6444), 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 Respondent 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.
During the past 3 fiscal years, from October 1, 2002, through
September 30, 2004, FDA received an average of 47 notifications per
year with an average of 1 notification per submitting manufacture or
distributor. In comparison, during the previous 3 fiscal years, from
October 1, 1999, through September 30, 2001, FDA received an average of
23 notifications per year with an average of 1 notification per
submitter. The annual average number
[[Page 22887]]
of notifications FDA received during fiscal years 2002 to 2004
increased by 24. Because the premarket notification program for new
dietary ingredients is relatively new, the agency anticipates that this
upward trend in receiving more notifications will continue over the
next 3 fiscal years, from October 1, 2005, through September 30, 2007.
Therefore, FDA estimates that the agency will receive an annual average
of 71 notifications with an annual average of 1 notification per
submitter during fiscal years 2005 to 2007.
Dated: April 26, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-8767 Filed 5-2-05; 8:45 am]
BILLING CODE 4160-01-S