80 FR 10121 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notification for a New Dietary Ingredient

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 37 (February 25, 2015)

Page Range		10121-10122
FR Document		2015-03833

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 (the PRA).

Federal Register, Volume 80 Issue 37 (Wednesday, February 25, 2015)

[Federal Register Volume 80, Number 37 (Wednesday, February 25, 2015)]
[Notices]
[Pages 10121-10122]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-03833]


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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.

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

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 (the PRA).

DATES: Fax written comments on the collection of information by March 
27, 2015.

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.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE--14526, Silver 
Spring, MD 20993-0002, 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--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, the 
manufacturer or distributor of the dietary supplement or of the new 
dietary ingredient 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 the new dietary ingredient will reasonably be expected to be 
safe. FDA's implementing regulation, 21 CFR 190.6, requires this 
information to be submitted to the Office of Nutrition, Labeling, and 
Dietary Supplements (ONLDS) in the form of a notification. Under Sec.  
190.6(b), the notification must include the following: (1) The name and 
complete address of the manufacturer or distributor, (2) the name of 
the new dietary ingredient, (3) a description of the dietary 
supplement(s) that contain the new dietary ingredient, including the 
level of the new dietary ingredient in the dietary supplement and the 
dietary supplement's conditions of use, (4) the history of use or other 
evidence of safety establishing that the new dietary ingredient will 
reasonably be expected to be safe when used under the conditions 
recommended or suggested in the labeling of the dietary supplement, and 
(5) the signature of a responsible person designated by the 
manufacturer or distributor.
    These premarket notification requirements are designed to enable us 
to monitor the introduction into the marketplace of new dietary 
ingredients and dietary supplements that contain new dietary 
ingredients, in order to protect consumers from ingredients and 
products whose safety is unknown. We use the information collected in 
new dietary ingredient notifications to evaluate the safety of new 
dietary ingredients in dietary supplements and to support regulatory 
action against ingredients and products that are potentially unsafe.
    We are developing an electronic portal that interested persons will 
be able to use to electronically submit their notifications to ONLDS 
via FDA Unified Registration and Listing System (FURLS). Firms that 
prefer to submit a paper notification in a format of their own choosing 
will still have the option to do so, however. Form FDA 3880 prompts a 
submitter to input the elements of a new dietary ingredient 
notification (NDIN) in a standard format and helps the submitter 
organize its NDIN to focus on the information needed for our safety 
review. Safety information will be submitted via a supplemental form 
entitled ``New Dietary Ingredient (NDI) Safety Information.'' This form 
provides a standard format to describe the history of use or other 
evidence of safety on which the manufacturer or distributor bases its 
conclusion that the new dietary ingredient will be reasonably expected 
to be safe under the conditions of use recommended or suggested in the 
labeling of the dietary supplement, as well as related identity 
information that is necessary to demonstrate safety by showing that the 
new dietary ingredient and dietary supplement(s) that are the subject 
of the notification are the same or similar to the ingredients and 
products for which safety data and information have been provided. 
Draft screenshots of Form FDA 3880 and the supplemental safety 
information form are available for comment at http://www.fda.gov/Food/DietarySupplements/NewDietaryIngredientsNotificationProcess/ucm356620.htm.
    Description of Respondents: The respondents to this collection of 
information are manufacturers and distributors in the dietary 
supplement industry; specifically, firms that manufacture or distribute 
new dietary ingredients or dietary supplements that contain a new 
dietary ingredient.
    In the Federal Register of November 14, 2014 (79 FR 68275), we 
published a 60-day notice requesting public comment on the proposed 
extension of this collection of information. We received three comments 
in response to the notice. Two of the comments were unrelated to the 
PRA, and therefore we did not consider them.

[[Page 10122]]

    The third comment asserted that we underestimated the reporting 
burden of the NDIN procedures under Sec.  190.6 by failing to take into 
account the recommendations in the draft guidance entitled ``Dietary 
Supplements: New Dietary Ingredient Notifications and Related Issues'' 
(the 2011 draft guidance) (available at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/DietarySupplements/ucm257563.htm). FDA announced the availability of 
the 2011 draft guidance for comment in a notice published in the 
Federal Register of July 5, 2011 (76 FR 39111).
    Although we agree with the commenter that information collection 
recommendations in guidance are subject to the PRA, we intend to meet 
our PRA obligations in that regard separately at a later time. The 2011 
draft guidance was published solely for the purpose of seeking comment, 
and it has not been made final. Moreover, FDA intends to publish a 
revised draft guidance for comment later this year, and the revised 
draft guidance will supersede the 2011 draft guidance. Although we 
expect the revised draft guidance to be followed by a final guidance, 
there will be an interim period where no guidance on NDINs is in 
effect. The purpose of the current PRA proceeding is to seek comment on 
and obtain OMB approval for the NDIN collections of information in 
effect during this interim period, which are those found in the FDA's 
NDIN regulations at Sec.  190.6 and in the electronic NDIN submission 
forms that we have made available for comment. After publishing a 
revised draft guidance on NDINs and related issues, we intend to 
publish a 60-day notice inviting comment on the proposed collections of 
information associated with that document. At that time, we will 
carefully evaluate all comments we receive.
    We estimate the burden of this collection of information as 
follows:

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

    We believe that the burden of the premarket notification 
requirement on industry is limited and reasonable because we are 
requesting only safety and identity information that the manufacturer 
or distributor should already have developed to satisfy itself that a 
dietary supplement containing a new dietary ingredient is in compliance 
with the FD&C Act. In the past, commenters have argued that our burden 
estimate is too low. We carefully considered the issue and believe that 
burden estimates of greater than 20 hours per notification likely 
include the burden associated with researching and generating safety 
data for a new dietary ingredient. Under section 413(a)(2) of the FD&C 
Act, a dietary supplement that contains a new dietary ingredient is 
deemed to be adulterated unless there is a history of use or other 
evidence of safety establishing that the new dietary ingredient will 
reasonably be expected to be safe under the conditions of use 
recommended or suggested in the labeling of the dietary supplement. 
This requirement is separate from and additional to the requirement to 
submit a premarket notification for the new dietary ingredient. FDA's 
regulation on NDINs, Sec.  190.6(a), requires the manufacturer or 
distributor of the dietary supplement, or of the new dietary 
ingredient, to submit to FDA the information that forms the basis for 
its conclusion that a dietary supplement containing the new dietary 
ingredient will reasonably be expected to be safe. Thus, Sec.  190.6 
only requires the manufacturer or distributor to extract and summarize 
information that should have already been developed to meet the safety 
requirement in section 413(a)(2) of the FD&C Act. We estimate that 
extracting and summarizing the relevant information from what exists in 
the company's files and presenting it in a format that meets the 
requirements of Sec.  190.6 will take approximately 20 hours of work 
per notification. However, we seek comments on this estimate. We 
encourage comments offering alternative burden estimates to include 
documentation to support the alternative estimate.
    We further estimate that 55 respondents will submit 1 premarket 
notification each. We base our estimate of the number of respondents on 
notifications received over the past 3 years, which averaged about 55 
notifications per year.

    Dated: February 19, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-03833 Filed 2-24-15; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 37 / Wednesday, February 25, 2015 / Notices 10121

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Number of Number of records Total annual Average burden per
21 CFR Section Total hours
recordkeepers per recordkeeper records recordkeeping

Total .................................. ............................ .............................. ............................ .................................................. 882,203
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: February 19, 2015. Premarket Notification for a New ingredients and products that are
Leslie Kux, Dietary Ingredient—21 CFR 190.6 potentially unsafe.
Associate Commissioner for Policy. (OMB Control Number 0910–0330)— We are developing an electronic
[FR Doc. 2015–03881 Filed 2–24–15; 8:45 am] Extension portal that interested persons will be
BILLING CODE 4164–01–P
able to use to electronically submit their
Section 413(a) of the Federal Food, notifications to ONLDS via FDA Unified
Drug, and Cosmetic Act (the FD&C Act) Registration and Listing System
DEPARTMENT OF HEALTH AND (21 U.S.C. 350b(a)) provides that at least (FURLS). Firms that prefer to submit a
HUMAN SERVICES 75 days before the introduction or paper notification in a format of their
delivery for introduction into interstate own choosing will still have the option
Food and Drug Administration commerce of a dietary supplement that to do so, however. Form FDA 3880
contains a new dietary ingredient, the prompts a submitter to input the
[Docket No. FDA–2013–N–0878]
manufacturer or distributor of the elements of a new dietary ingredient
Agency Information Collection dietary supplement or of the new notification (NDIN) in a standard format
Activities; Submission for Office of dietary ingredient is to submit to us (as and helps the submitter organize its
Management and Budget Review; delegate for the Secretary of Health and NDIN to focus on the information
Comment Request; Premarket Human Services) information upon needed for our safety review. Safety
Notification for a New Dietary which the manufacturer or distributor information will be submitted via a
Ingredient has based its conclusion that a dietary supplemental form entitled ‘‘New
supplement containing the new dietary Dietary Ingredient (NDI) Safety
AGENCY: Food and Drug Administration, ingredient will reasonably be expected Information.’’ This form provides a
HHS. to be safe. FDA’s implementing standard format to describe the history
ACTION: Notice. regulation, 21 CFR 190.6, requires this of use or other evidence of safety on
information to be submitted to the which the manufacturer or distributor
SUMMARY: The Food and Drug Office of Nutrition, Labeling, and bases its conclusion that the new dietary
Administration (FDA or we) is Dietary Supplements (ONLDS) in the ingredient will be reasonably expected
announcing that a proposed collection to be safe under the conditions of use
form of a notification. Under § 190.6(b),
of information has been submitted to the recommended or suggested in the
the notification must include the
Office of Management and Budget labeling of the dietary supplement, as
following: (1) The name and complete
(OMB) for review and clearance under well as related identity information that
address of the manufacturer or
the Paperwork Reduction Act of 1995 is necessary to demonstrate safety by
distributor, (2) the name of the new
(the PRA). showing that the new dietary ingredient
dietary ingredient, (3) a description of
DATES: Fax written comments on the
the dietary supplement(s) that contain and dietary supplement(s) that are the
collection of information by March 27, the new dietary ingredient, including subject of the notification are the same
2015. the level of the new dietary ingredient or similar to the ingredients and
ADDRESSES: To ensure that comments on in the dietary supplement and the products for which safety data and
the information collection are received, dietary supplement’s conditions of use, information have been provided. Draft
OMB recommends that written screenshots of Form FDA 3880 and the
(4) the history of use or other evidence
comments be faxed to the Office of supplemental safety information form
of safety establishing that the new
Information and Regulatory Affairs, are available for comment at http://
dietary ingredient will reasonably be
OMB, Attn: FDA Desk Officer, FAX: www.fda.gov/Food/Dietary
expected to be safe when used under the
202–395–7285, or emailed to oira_ Supplements/NewDietaryIngredients
conditions recommended or suggested
submission@omb.eop.gov. All NotificationProcess/ucm356620.htm.
in the labeling of the dietary Description of Respondents: The
comments should be identified with the supplement, and (5) the signature of a
OMB control number 0910–0330. Also respondents to this collection of
responsible person designated by the information are manufacturers and
include the FDA docket number found manufacturer or distributor.
in brackets in the heading of this distributors in the dietary supplement
document. These premarket notification industry; specifically, firms that
requirements are designed to enable us manufacture or distribute new dietary
FOR FURTHER INFORMATION CONTACT: FDA to monitor the introduction into the ingredients or dietary supplements that
PRA Staff, Office of Operations, Food marketplace of new dietary ingredients contain a new dietary ingredient.
and Drug Administration, 8455 and dietary supplements that contain In the Federal Register of November
asabaliauskas on DSK5VPTVN1PROD with NOTICES

Colesville Rd., COLE—14526, Silver new dietary ingredients, in order to 14, 2014 (79 FR 68275), we published a
Spring, MD 20993–0002, PRAStaff@ protect consumers from ingredients and 60-day notice requesting public
fda.hhs.gov. products whose safety is unknown. We comment on the proposed extension of
SUPPLEMENTARY INFORMATION: In use the information collected in new this collection of information. We
compliance with 44 U.S.C. 3507, FDA dietary ingredient notifications to received three comments in response to
has submitted the following proposed evaluate the safety of new dietary the notice. Two of the comments were
collection of information to OMB for ingredients in dietary supplements and unrelated to the PRA, and therefore we
review and clearance. to support regulatory action against did not consider them.

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10122 Federal Register / Vol. 80, No. 37 / Wednesday, February 25, 2015 / Notices

The third comment asserted that we Although we agree with the PRA proceeding is to seek comment on
underestimated the reporting burden of commenter that information collection and obtain OMB approval for the NDIN
the NDIN procedures under § 190.6 by recommendations in guidance are collections of information in effect
failing to take into account the subject to the PRA, we intend to meet during this interim period, which are
recommendations in the draft guidance our PRA obligations in that regard those found in the FDA’s NDIN
entitled ‘‘Dietary Supplements: New separately at a later time. The 2011 draft regulations at § 190.6 and in the
Dietary Ingredient Notifications and guidance was published solely for the electronic NDIN submission forms that
Related Issues’’ (the 2011 draft purpose of seeking comment, and it has we have made available for comment.
guidance) (available at http:// not been made final. Moreover, FDA After publishing a revised draft
www.fda.gov/Food/Guidance intends to publish a revised draft guidance on NDINs and related issues,
Regulation/GuidanceDocuments guidance for comment later this year, we intend to publish a 60-day notice
RegulatoryInformation/ and the revised draft guidance will inviting comment on the proposed
supersede the 2011 draft guidance. collections of information associated
DietarySupplements/ucm257563.htm).
Although we expect the revised draft with that document. At that time, we
FDA announced the availability of the
guidance to be followed by a final will carefully evaluate all comments we
2011 draft guidance for comment in a guidance, there will be an interim receive.
notice published in the Federal Register period where no guidance on NDINs is We estimate the burden of this
of July 5, 2011 (76 FR 39111). in effect. The purpose of the current collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
21 CFR section responses per burden per Total hours
respondents responses
respondent response

190.6 .................................................................................... 55 1 55 20 1,100
1 There are no operating and maintenance costs associated with this collection of information.

We believe that the burden of the manufacturer or distributor to extract DEPARTMENT OF HEALTH AND
premarket notification requirement on and summarize information that should HUMAN SERVICES
industry is limited and reasonable have already been developed to meet
because we are requesting only safety the safety requirement in section Food and Drug Administration
and identity information that the 413(a)(2) of the FD&C Act. We estimate [Docket No. FDA–2015–D–0230]
manufacturer or distributor should that extracting and summarizing the
already have developed to satisfy itself relevant information from what exists in Technical Performance Assessment of
that a dietary supplement containing a the company’s files and presenting it in Digital Pathology Whole Slide Imaging
new dietary ingredient is in compliance a format that meets the requirements of Devices; Draft Guidance for Industry
with the FD&C Act. In the past, § 190.6 will take approximately 20 and Food and Drug Administration
commenters have argued that our hours of work per notification. Staff; Availability
burden estimate is too low. We carefully
However, we seek comments on this AGENCY: Food and Drug Administration,
considered the issue and believe that
estimate. We encourage comments HHS.
burden estimates of greater than 20
hours per notification likely include the offering alternative burden estimates to ACTION: Notice.
burden associated with researching and include documentation to support the
generating safety data for a new dietary alternative estimate. SUMMARY: The Food and Drug
ingredient. Under section 413(a)(2) of We further estimate that 55 Administration (FDA) is announcing the
the FD&C Act, a dietary supplement that respondents will submit 1 premarket availability of a draft guidance entitled
contains a new dietary ingredient is notification each. We base our estimate ‘‘Technical Performance Assessment of
deemed to be adulterated unless there is of the number of respondents on Digital Pathology Whole Slide Imaging
a history of use or other evidence of Devices.’’ This draft guidance provides
notifications received over the past 3
safety establishing that the new dietary industry and Agency staff with
years, which averaged about 55
ingredient will reasonably be expected recommendations regarding the
notifications per year. technical performance assessment data
to be safe under the conditions of use
recommended or suggested in the Dated: February 19, 2015. that should be provided for regulatory
labeling of the dietary supplement. This Leslie Kux, evaluation of a digital whole slide
requirement is separate from and Associate Commissioner for Policy. imaging (WSI) system. This draft
additional to the requirement to submit [FR Doc. 2015–03833 Filed 2–24–15; 8:45 am]
guidance is not final nor is it in effect
a premarket notification for the new at this time.
BILLING CODE 4164–01–P
dietary ingredient. FDA’s regulation on DATES: Although you can comment on
NDINs, § 190.6(a), requires the any guidance at any time (see 21 CFR
asabaliauskas on DSK5VPTVN1PROD with NOTICES

manufacturer or distributor of the 10.115(g)(5)), to ensure that the Agency
dietary supplement, or of the new considers your comment of this draft
dietary ingredient, to submit to FDA the guidance before it begins work on the
information that forms the basis for its final version of the guidance, submit
conclusion that a dietary supplement either electronic or written comments
containing the new dietary ingredient on the draft guidance by May 26, 2015.
will reasonably be expected to be safe. ADDRESSES: An electronic copy of the
Thus, § 190.6 only requires the guidance document is available for

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Document Created: 2015-12-18 13:08:42
Document Modified: 2015-12-18 13:08:42

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Fax written comments on the collection of information by March 27, 2015.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE--14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation		80 FR 10121

80 FR 10121 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notification for a New Dietary Ingredient

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 37 (February 25, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration