Document ID: FDA-2008-N-0170-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notification for a New Dietary Ingredient
Posted Date: 2008-06-19T04:00Z

[Federal Register: June 19, 2008 (Volume 73, Number 119)]
[Notices]               
[Page 34940-34941]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19jn08-72]                         

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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 baguilar@omb.eop.gov. 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]

BILLING CODE 4160-01-S