[Federal Register Volume 64, Number 26 (Tuesday, February 9, 1999)]
[Notices]
[Pages 6364-6365]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-3014]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-0124]


Agency Information Collection Activities: Proposed Collection; 
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 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 on which it has concluded 
that a dietary supplement containing a new dietary ingredient will 
reasonably be expected to be safe.

DATES: Submit written comments on the collection of information by 
April 12, 1999.

ADDRESSES: 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 
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 below.
    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.

[[Page 6365]]

New Dietary Ingredient Premarket Notification--21 CFR 190.6 (OMB 
Control Number 0910-0330--Extension)

    Description: Section 413(a) of the Federal Food, Drug, and Cosmetic 
Act (the act) (21 U.S.C. 350b(a)) provides for the notification of the 
Secretary of Health and Human Services (the Secretary) (and by 
delegation FDA) at least 75 days before the introduction or delivery 
for introduction into interstate commerce of a dietary supplement that 
contains a new dietary ingredient.
    The agency established 21 CFR 190.6 as the procedural regulation 
for this program. This regulation provides details of the 
administrative procedures associated with the submission and identifies 
the information that must be included in the submission in order to 
meet the requirements of section 413(a) of the act and to show the 
basis on which a manufacturer or distributor of a new dietary 
ingredient or a dietary supplement containing a new dietary ingredient 
has concluded that the dietary supplement containing such dietary 
ingredient will reasonably be expected to be safe.
    Description of Respondents: Businesses or other for-profit 
organizations.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table 1.--Estimated Annual Reporting Burden1
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                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
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190.6                                  11               1              11              20             220
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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. This 
estimate is based on the average number of premarket notifications 
received by the agency in the last 3 years.

    Dated: February 1, 1999.
 William K. Hubbard,
 Associate Commissioner for Policy Coordination.
[FR Doc. 99-3014 Filed 2-8-99; 8:45 am]
BILLING CODE 4160-01-F