
[Federal Register Volume 78, Number 222 (Monday, November 18, 2013)]
[Notices]
[Pages 69095-69097]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-27536]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0878]


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 or we) 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 
December 18, 2013.

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: 202-395-7285, or emailed to oira_submission@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.

[[Page 69096]]


FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, PRAStaff@fda.hhs.gov.

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 (NDI)--21 CFR 190.6 
(OMB Control Number 0910-0330)--Extension

    Section 413(a) of the Federal Food, Drug, and Cosmetic Act (FD&C 
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 an NDI, a manufacturer or distributor 
of dietary supplements or of an NDI is to submit to us (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 an NDI 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 an NDI, or of an NDI, 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 NDI, (3) a description 
of the dietary supplements that contain the NDI, 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 us to monitor the introduction into the food supply of NDIs and 
dietary supplements that contain NDIs, in order to protect consumers 
from the introduction of unsafe dietary supplements into interstate 
commerce. We use the information collected under these regulations to 
help ensure that a manufacturer or distributor of a dietary supplement 
containing an NDI is in full compliance with the FD&C Act. We are 
currently developing an electronic means for submitting this 
information.
    Description of Respondents: The respondents to this collection of 
information are firms in the dietary supplement industry, including 
dietary supplement and dietary ingredient manufacturers, packagers and 
re-packagers, holders, labelers and re-labelers, distributors, 
warehouses, exporters, and importers.
    In the Federal Register of August 26, 2013 (78 FR 52773), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information; two comments were received with one 
containing multiple comments. Some comments were outside the scope of 
the four collection of information topics being solicited and therefore 
will not be discussed in this document.
    One comment suggested providing drop-down menus to facilitate data 
entry. FDA appreciates this suggestion and will continue to consider 
various configurations for submitting information in electronic form 
that are most effective and efficient for respondents. Another comment 
stated that FDA's estimate of 20 hours per notification is not 
accurate. The comment indicated that 40 to 60 hours were required to 
extract and summarize relevant information from the firm's files, and 
that an additional 20 to 40 hours was needed to format the information 
to meet NDI requirements. FDA deliberated over this comment, but 
believes that collecting and compiling data under applicable regulatory 
requirements for the premarket notification program places a minimal 
burden on respondents. As noted both in our August 26, 2013, notice and 
in this document, Sec.  190.6(a) requires each manufacturer or 
distributor of an NDI, or dietary supplement containing an NDI, to 
submit notification of the basis for their conclusion that the 
supplement or ingredient will reasonably be expected to be safe. 
Because we are requesting only that information that the manufacturer 
or distributor should have already developed, we believe that 20 hours 
per submission is an appropriate burden estimate.
    Both comments note that in the Federal Register of July 5, 2011 (76 
FR 39111), FDA issued a draft guidance entitled ``Dietary Supplements: 
New Dietary Ingredient Notifications and Related Issues'' (available at 
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/DietarySupplements/ucm257563.htm) and suggested that FDA underestimated the reporting 
burden of the notification procedures under Sec.  190.6 because we 
failed to take into account the provisions of the draft guidance. FDA 
considered this response but submits that the notification procedure 
requirements set forth in its regulations at Sec.  190.6 remain 
unchanged. The collection of information in this instant analysis is 
exclusive of the draft guidance and pertains only to the subject 
regulations. However, as stated in the notice of availability for the 
draft guidance, FDA does intend to publish a 60-day notice inviting 
comment on the information collection burden associated with that 
document and will carefully evaluate all comments it receives.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                          Number of
  21 CFR section       Number of        responses per       Total annual      Average burden      Total hours
                      respondents         respondent         responses         per response
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          190.6                 55                  1                 55                 20              1,100
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    We believe that there will be minimal burden on the industry to 
generate data to meet the requirements of the premarket notification 
program because we are requesting only that information that the 
manufacturer or distributor should already have developed to satisfy 
itself that a dietary supplement containing an NDI is in full 
compliance with the FD&C Act. In the past, commenters argued that our 
burden estimate is too low. Section 190.6(a) requires each manufacturer 
or distributor of a dietary supplement containing an NDI, or of an NDI, 
to submit notification of the basis for their conclusion that said 
supplement or ingredient will reasonably be expected to be safe. 
Section 190.6 requests simply the extraction and summarization of the 
safety data that should have already been developed by the manufacturer 
or distributor. Thus, we estimate that extracting and summarizing the 
relevant

[[Page 69097]]

information from the company's files, and presenting it in a format 
that will meet the requirements of section 413 of the FD&C Act will 
require a burden of approximately 20 hours of work per submission.
    We estimate that 55 respondents will submit one premarket 
notification each and that it will take a respondent 20 hours to 
prepare the notification, for a total of 1,100 hours. The estimated 
number of premarket notifications and hours per response is an average 
based on our experience with notifications received during the last 3 
years and information from firms that have submitted recent premarket 
notifications.

    Dated: November 13, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-27536 Filed 11-15-13; 8:45 am]
BILLING CODE 4160-01-P


