[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
----------------------------------------------------------------------------------------------------------------
190.6 11 1 11 20 220
----------------------------------------------------------------------------------------------------------------
\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
