[Federal Register Volume 86, Number 70 (Wednesday, April 14, 2021)]
[Notices]
[Pages 19623-19625]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07641]
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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, Agency, 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: Submit written comments (including recommendations) on the
collection of information by May 14, 2021.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0330. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
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.
[[Page 19624]]
Premarket Notification for a New Dietary Ingredient
OMB Control Number 0910-0330--Extension
This information collection supports Agency regulations. Under
section 413(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 350b(a)), the manufacturer or distributor of a new dietary
ingredient (NDI), or of the dietary supplement that contains the NDI,
must submit a premarket notification to FDA (as delegate for the
Secretary of Health and Human Services) at least 75 days before
introducing the product into interstate commerce or delivering it for
introduction into interstate commerce, unless the NDI and any other
dietary ingredients in the dietary supplement ``have been present in
the food supply as an article used for food in a form in which the food
has not been chemically altered'' (21 U.S.C. 350b(a)(1)). The
notification must contain the information which provides the basis on
which the manufacturer or distributor of the NDI or dietary supplement
has concluded that the dietary supplement containing the NDI will
reasonably be expected to be safe (21 U.S.C. 350b(a)(2)).
FDA's implementing regulation, Sec. 190.6 (21 CFR 190.6),
specifies the procedure for submitting a premarket NDI notification and
the information the manufacturer or distributor must include in the
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 NDI; (3) a description of the dietary
supplement(s) that contains the NDI, including the level of the NDI in
the dietary supplement and the conditions of use recommended or
suggested in the labeling of the dietary supplement, or if no
conditions of use are recommended or suggested in the supplement's
labeling, the ordinary conditions of use of the supplement; (4) the
history of use or other evidence of safety establishing that the NDI
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 NDIs and dietary
supplements that contain NDIs in order to protect consumers from
ingredients and products whose safety is unknown. We use the
information collected in NDI notifications to evaluate the safety of
NDIs in dietary supplements and to support regulatory action against
ingredients and products that are potentially unsafe.
FDA developed an electronic portal (Form FDA 3880) that respondents
may use to electronically submit their notifications to us via the
Center for Food Safety and Applied Nutrition (CFSAN) Online Submission
Module (COSM). COSM was developed to assist respondents when filing
regulatory submissions and is specifically designed to aid users
wishing to file submissions with CFSAN. COSM allows safety and other
information to be uploaded and submitted online via Form FDA 3880. 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 NDI is reasonably expected to be safe under the
conditions of use recommended or suggested in the labeling of the
dietary supplement, as well as a description of the ingredient and
other information. Firms that prefer to submit a paper notification in
a format of their own choosing have the option to do so; however, Form
FDA 3880 prompts a submitter to input the elements of an NDI
notification in a standard format that we will be able to review
efficiently. Form FDA 3880 may be accessed at https://www.fda.gov/Food/DietarySupplements/NewDietaryIngredientsNotificationProcess/default.htm.
Description of Respondents: The respondents to this collection of
information are certain manufacturers and distributors in the dietary
supplement industry.
In the Federal Register of October 16, 2020 (85 FR 65830), we
published a 60-day notice requesting public comment on the proposed
collection of information. A number of comments were received
expressing general interest in labeling requirements applicable to
dietary supplements. Other comments were received pertaining to related
Agency draft guidance, one suggesting that FDA: (1) Failed to account
for the cost of removing from the market dietary supplements suddenly
deemed New Dietary Ingredients for the first time in the guidance; (2)
substantially underestimated the number and cost of New Dietary
Ingredient submissions that must be filed to comply with the guidance;
and (3) grossly and dangerously undervalued the economic impact the
guidance will have on the dietary supplement industry and the economy
as a whole.
While we appreciate all feedback regarding Agency information
collection activities, as we communicated in our notice of March 28,
2018 (83 FR 13281), the data analysis offered by the comment does not
provide a basis upon which we can revise our burden estimate under the
PRA. Regulatory requirements regarding premarket notification for new
dietary ingredients are set forth under 21 CFR 190.6 and were
established by final rule of September 23, 1997 (62 FR 49886). Notices
published in the Federal Register in compliance with the PRA seek to
improve information collection activities by evaluating our need for
the information discussed in the notice and specific ways we might
utilize technology and/or enhance our collection techniques and
mechanisms to minimize burden on respondents who are subject to
applicable those requirements. Finally, notices of availability for
Agency guidance documents are published consistent with regulations in
21 CFR 10.115 (Good Guidance Practices), which provide for public
comment at any time.
We estimate 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; Dietary Supplements......................................... 55 1 55 20 1,100
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\1\ There are no operating and maintenance costs associated with this collection of information.
[[Page 19625]]
Based on our experience with the information collection over the
past 3 years, we estimate that 55 respondents will submit 1 premarket
notification each. 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. We believe
that the burden of the premarket notification requirement on industry
is 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 the
NDI is in compliance with the FD&C Act.
If the required premarket notification is not submitted to FDA,
section 413(a) of the FD&C Act provides that the dietary supplement
containing the NDI is deemed to be adulterated under section 402(f) of
the FD&C Act (21 U.S.C. 342(f)). Even if the notification is submitted
as required, the dietary supplement containing the NDI is adulterated
under section 402(f) of the FD&C Act unless there is a history of use
or other evidence of safety establishing that the NDI, when used under
the conditions recommended or suggested in the labeling of the dietary
supplement, will reasonably be expected to be safe. This requirement is
separate from and additional to the requirement to submit a premarket
notification for the NDI. FDA's regulation on NDI notifications, Sec.
190.6(a), requires the manufacturer or distributor of the dietary
supplement or of the NDI to submit to FDA the information that forms
the basis for its conclusion that a dietary supplement containing the
NDI 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.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Dated: April 8, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-07641 Filed 4-13-21; 8:45 am]
BILLING CODE 4164-01-P