[Federal Register Volume 67, Number 53 (Tuesday, March 19, 2002)]
[Notices]
[Pages 12570-12571]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-6493]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0062]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Premarket Notification for a New Dietary Ingredient

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the procedure by which a 
manufacturer or distributor of dietary supplements or of a new dietary 
ingredient is to submit information to FDA upon which it has based its 
conclusion that a dietary supplement containing a new dietary 
ingredient will reasonably be expected to be safe.

DATES: Submit written or electronic comments on the collection of 
information by May 20, 2002.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
Submit written comments on the collection of information to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. All comments should be identified 
with the docket number found in brackets in the heading of this 
document.

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: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR

[[Page 12571]]

1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on: (1) Whether the proposed collection of information 
is necessary for the proper performance of FDA's functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology. New Dietary Ingredient Premarket Notification--
21 CFR 190.6 (OMB Control No. 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: (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.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                           Annual
                           21 CFR Section                                 No. of       frequency  per    Total annual      Hours per       Total hours
                                                                       respondents        response        responses         response
--------------------------------------------------------------------------------------------------------------------------------------------------------
190.6..............................................................              35                1               35               20             700
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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.
    This estimate is based on the annual average number of premarket 
notifications FDA received during the last 3 years (i.e., 1999-2001), 
which was 23. Twenty-three represents 12 more notifications than the 
agency received as an annual average during the previous 3-year period 
(i.e., 1996-1998). Therefore, FDA anticipates a similar upward trend 
will be seen in the annual average number of notifications it receives 
during 2002-2004, which is estimated to be 35 (23 + 12 = 35).

    Dated: March 5, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-6493 Filed 3-18-02; 8:45 am]
BILLING CODE 4160-01-P