[Federal Register Volume 76, Number 161 (Friday, August 19, 2011)]
[Notices]
[Pages 51986-51988]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-21237]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0410]


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 (the PRA).

DATES: Fax written comments on the collection of information by 
September 19, 2011.

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 e-mailed to [email protected]. 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: 
    Denver Presley, Jr., Office of Information Management, Food and 
Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 
301-796-3793.

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

    Section 413(a) of the Federal Food, Drug, and Cosmetic Act (the 
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 a new dietary ingredient (NDI), a 
manufacturer or distributor of an NDI, or of the dietary supplement 
that contains the NDI, is to submit to FDA (as delegate for the 
Secretary of Health and Human Services) the information which is the 
basis on which the manufacturer or distributor has concluded that a 
dietary supplement containing an NDI will reasonably be expected to be 
safe. Section 190.6 (21 CFR 190.6) implements this statutory provision. 
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.

[[Page 51987]]

    The notification requirements described previously are designed to 
enable FDA 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. FDA uses 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.
    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 June 3, 2011 (76 FR 32214), FDA 
published a 60-day notice (the June 3, 2011, notice) requesting public 
comment on the proposed extension of this collection of information. 
FDA received five letters in response to the notice, each containing 
multiple comments. Several comments were generally supportive of FDA's 
information collection provisions in Sec.  190.6. Additional comments 
were outside the scope of the four collection of information topics on 
which the notice solicits comments, and will not be discussed in this 
document.
    (Comment 1) FDA received several comments on the utility of the 
premarket notification procedures. Some comments stated that the 
information collection is necessary for the performance of FDA's 
functions and that the information will be of great practical utility 
to FDA in carrying out its role of protecting consumers from the 
introduction of unsafe dietary supplements into interstate commerce.
    (Response) FDA agrees. As noted, section 413(a) of the FD&C Act 
requires a manufacturer or distributor of an NDI, or of the dietary 
supplement that contains the NDI, to submit the information which is 
the basis on which the manufacturer or distributor has concluded that a 
dietary supplement containing an NDI will reasonably be expected to be 
safe. Section 190.6 implements this statutory provision, and is 
essential to protecting consumers from unsafe dietary supplements.
    (Comment 2) Several comments argued that FDA underestimated the 
burden hours associated with complying with the provisions of Sec.  
190.6. One comment argued that FDA's estimate of 20 hours per 
notification is too low and stated that firms filing notifications 
require 100 to 350 hours to generate data to meet the requirements of 
an NDI notification. The comment argued that FDA did not fully consider 
the time needed to acquire the required information.
    (Response) FDA disagrees. FDA appreciates the data provided in the 
comment. However, the Agency stands by its estimate of the paperwork 
burden resulting from Sec.  190.6. As noted in the June 3, 2011, 
notice, Sec.  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. The Agency believes 
that there is 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 as the basis for its 
conclusion that a dietary supplement containing an NDI will reasonably 
be expected to be safe. Therefore, 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(a) of the FD&C Act and Sec.  190.6 will require a burden of 
approximately 20 hours of work per submission.
    (Comment 3) One comment argued that FDA's estimate of 20 hours per 
notification is too low and stated that FDA should use burden hour data 
from ``successful'' notifications only, indicating that the number of 
hours spent on notifications to which FDA does not object more 
accurately reflect the burden on industry.
    (Response) FDA disagrees that the estimate of 20 hours per 
notification is too low for the reasons stated in response to Comment 
2. In addition, the Agency does not regularly collect from those 
submitting notifications under Sec.  190.6 information about the number 
of hours they spent preparing the notifications, whether ``successful'' 
or ``unsuccessful.'' FDA appreciates the suggestion provided in the 
comment, however, and will consider doing so when it prepares its next 
regular information collection request for this collection.
    (Comment 4) One comment argued that FDA's estimate that it will 
receive 55 premarket notifications annually is inaccurate and ``deeply 
flawed.''
    (Response) FDA disagrees that the estimate of 55 notifications 
annually is inaccurate. As stated in the June 3, 2011, notice, the 
estimated number of premarket notifications is an average based on the 
Agency's experience with notifications received during the last 3 
years. FDA received 77 notifications in 2008, 39 notifications in 2009, 
and 48 notifications in 2010, for an average of 55 notifications. The 
sum of 77 + 39 + 48 equals 164. Dividing that sum by 3 yields an 
average of 54.66, which has been rounded up to 55.
    (Comment 5) Several comments argued that FDA incorrectly estimated 
that there are no capital costs associated with submitting premarket 
notifications under Sec.  190.6. Comments argued that FDA did not fully 
consider that notifiers invest significant capital resources in hiring 
consultants to extract and summarize information for NDI notifications, 
paying for full-text scientific journal articles and obtaining legal 
review of NDI notifications.
    (Response) FDA disagrees. The comment mischaracterizes the 
significant costs associated with hiring consultants, obtaining 
reference materials, and securing legal review of a notification as 
capital costs. For purposes of information collection requests under 
the PRA, capital costs are costs for equipment, machinery, and 
construction that, if not for FDA's request or requirement, the 
respondent would not incur. This includes buying new software and new 
computer equipment; monitoring, sampling, drilling and testing 
equipment; record storage facilities; the cost of purchasing or 
contracting out information collection services; and, postage costs to 
mail in a report. Capital costs do not include costs to achieve 
regulatory compliance with requirements not associated with the 
information collection. Hiring consultants to extract and summarize 
information for NDI notifications, paying for full-text scientific 
journal articles and obtaining legal review of NDI notifications are 
costs associated with developing information that the manufacturer or 
distributor uses to satisfy itself that a dietary supplement containing 
an NDI is in full compliance with section 413(a) of the FD&C Act; thus, 
these costs are not a capital cost because they are costs associated 
with achieving regulatory compliance with requirements of the FD&C Act, 
not costs associated specifically with filing a notification under 
Sec.  190.6. FDA notes that it has added a reference to these costs as 
``Costs to Respondent'' in section 12(b) of the supporting statement 
component of the information collection request that it has submitted 
to OMB.
    (Comment 6) Several comment letters noted that on July 5, 2011, FDA 
issued a draft guidance entitled ``Dietary Supplements: New Dietary 
Ingredient

[[Page 51988]]

Notifications and Related Issues'' (available at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/DietarySupplements/ucm257563.htm). Some comments argued that FDA 
underestimated the burden of the notification procedures under Sec.  
190.6 because it failed to take into account the provisions of the new 
draft guidance.
    (Response) FDA disagrees that we underestimated the burden of the 
notification procedures under Sec.  190.6. The collection of 
information analysis in the June 3, 2011, notice was limited to the 
sole collection of information contained in Sec.  190.6; that is, the 
regulation itself and not the provisions of the new draft guidance. The 
notification requirements set forth in Sec.  190.6 remain unchanged. 
The notice of availability for the new draft guidance (76 FR 39111, 
July 5, 2011) states that FDA will estimate the paperwork burden of the 
draft guidance document and submit it for OMB review under the PRA in a 
future issue of the Federal Register. Comments on the new draft 
guidance and any information collection provisions therein are outside 
the scope of the comment request in the June 3, 2011, notice, and will 
not be discussed in this document.
    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.

    As previously discussed, 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 as the basis for its 
conclusion that a dietary supplement containing an NDI will reasonably 
be expected to be safe. Therefore, 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(a) of the FD&C Act and Sec.  190.6 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 and information from 
firms that have submitted recent premarket notifications. FDA received 
77 notifications in 2008, 39 notifications in 2009, and 48 
notifications in 2010, for an average of 55 notifications. Accordingly, 
we estimate that 55 respondents will submit 1 premarket notification 
each and that it will take a respondent 20 hours to prepare the 
notification, for a total of 1,100 hours.

    Dated: August 15, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-21237 Filed 8-18-11; 8:45 am]
BILLING CODE 4160-01-P