[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
----------------------------------------------------------------------------------------------------------------
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