Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notification for a New Dietary Ingredient, 13281-13283 [2018-06155]
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Federal Register / Vol. 83, No. 60 / Wednesday, March 28, 2018 / Notices
(GSA Form 1142, Release of Claims), in
all correspondence.
Jeffrey A. Koses,
Director, Office of Acquisition Policy, Office
of Government-wide Policy.
[FR Doc. 2018–06170 Filed 3–27–18; 8:45 am]
BILLING CODE 6820–61–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–1880]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995
(PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, and to allow
a second opportunity for public
comment on the notice. Interested
persons are invited to send comments
regarding the burden estimate or any
other aspect of this collection of
information, including the necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions, the accuracy of
the estimated burden, ways to enhance
the quality, utility, and clarity of the
information to be collected, and the use
of automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
SUMMARY:
Comments on the collection(s) of
information must be received by the
OMB desk officer by April 27, 2018.
ADDRESSES: When commenting on the
proposed information collections,
please reference the document identifier
or OMB control number. To be assured
consideration, comments and
recommendations must be received by
the OMB desk officer via one of the
following transmissions: OMB, Office of
Information and Regulatory Affairs,
Attention: CMS Desk Officer, Fax
Number: (202) 395–5806 OR Email:
OIRA_submission@omb.eop.gov.
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DATES:
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To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ website address at
website address at https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.html.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
Reports Clearance Office at (410) 786–
1326.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (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. The term ‘‘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 publish a 30-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension or
reinstatement of an existing collection
of information, before submitting the
collection to OMB for approval. To
comply with this requirement, CMS is
publishing this notice that summarizes
the following proposed collection(s) of
information for public comment:
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Certification as
a Supplier of Portable X-Ray and
Portable X-Ray Survey Report Form and
Supporting Regulations; Use: CMS–1880
is initially completed by suppliers of
portable X-ray services, expressing an
interest in and requesting participation
in the Medicare program. This form
initiates the process of obtaining a
decision as to whether the conditions of
coverage are met as a portable X-ray
supplier. It also promotes data reduction
or introduction to, and retrieval from,
the Certification and Survey Provider
Enhanced Reporting (CASPER) by the
CMS Regional Offices (ROs). Form
Numbers: CMS–1880 (OMB control
number: 0938–0027); Frequency:
Occasionally; Affected Public: State,
Local, or Tribal Governments; Number
PO 00000
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of Respondents: 86; Total Annual
Responses: 86; Total Annual Hours: 22.
(For policy questions regarding this
collection contact Peter Ajounoma at
410–786–3580.)
Dated: March 23, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2018–06221 Filed 3–27–18; 8:45 am]
BILLING CODE 4120–01–P
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.
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
(PRA).
SUMMARY:
Fax written comments on the
collection of information by April 27,
2018.
DATES:
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.
ADDRESSES:
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, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 83, No. 60 / Wednesday, March 28, 2018 / Notices
Premarket Notification for a New
Dietary Ingredient—21 CFR 190.6
OMB Control Number 0910–0330—
Extension
This information collection supports
Agency regulations and accompanying
guidance. Specifically, 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 a new dietary
ingredient, the manufacturer or
distributor of the dietary supplement or
of the new dietary ingredient is to
submit to FDA (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, § 190.6
(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 § 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. FDA
uses 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.
FDA has developed an electronic
portal that respondents may use to
electronically submit their notifications
to ONLDS via FDA Unified Registration
and Listing Systems. Firms that prefer to
submit a paper notification in a format
of their own choosing 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 respondent organize its
NDIN to focus on the information
needed for FDA’s safety review. Safety
information may be submitted via a
supplemental form entitled ‘‘New
Dietary Ingredient 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 is 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. We
continue to invite comment on Form
FDA 3880 and the supplemental safety
information form, which may be found
on our website at https://www.fda.gov/
Food/DietarySupplements/NewDietary
IngredientsNotificationProcess/
default.htm.
In the Federal Register of November
17, 2017 (82 FR 54355), we published a
60-day notice requesting public
comment on the proposed extension of
this collection of information. One
comment suggested ways FDA might
assist respondents by developing
‘‘specific guidance pertaining to the use
and submission of master files to help
determine whether a dietary ingredient
should be the subject of an NDIN or
exempted from notification.’’ A second
comment suggested 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; (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.
FDA appreciates this feedback. As
noted, FDA has issued a draft guidance
on Dietary Supplements: New Dietary
Ingredient Notifications and Related
Issues and will take the comment on
additional guidance into consideration
when finalizing the draft guidance. As
resources allow, FDA may consider
revised or additional guidance to assist
respondents to the information
collection. Relatedly, with regard to
comments about costs or economic
impact, FDA notes that, consistent with
our regulations at 21 CFR part 10.115
(Good Guidance Practices),
recommendations found in the draft
guidance document are for comment
only. In addition, the data analysis
proffered regarding costs does not
provide a basis upon which we can
revise our burden estimate under the
PRA. 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 the applicable
regulatory requirements.
We therefore retain the following
estimate:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
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21 CFR Section
190.6; Dietary Supplements ................................................
1 There
Number of
responses per
respondent
55
Total annual
responses
1
55
Average
burden per
response
(in hours)
Total hours
20
are no capital costs or operating and maintenance costs associated with this collection of information.
2 The ‘‘Guidance’’ refers to a draft guidance
published for comment in August 2016 and
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Federal Register / Vol. 83, No. 60 / Wednesday, March 28, 2018 / Notices
We have made no adjustments to the
currently approved burden estimate for
the information collection. While we
have received comments previously
suggesting our burden estimate may be
too low, the comments did not discuss
the basis for such a conclusion. We
therefore specifically invite individual
respondent experience with the
information collection and associated
collection burden.
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 assume that extracting and
summarizing relevant information from
existing files and presenting it in a
format that meets the requirements of
§ 190.6 will take approximately 20
hours of work per notification. We have
carefully considered the burden
associated with the premarket
notification requirement and believe
that estimates greater than 20 hours are
likely to include burden associated with
researching and generating safety data
for a new dietary ingredient. We believe
that the burden of the premarket
notification requirement on industry is
minimal 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. 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
new dietary ingredient notifications,
§ 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, § 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.
VerDate Sep<11>2014
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Dated: March 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–06155 Filed 3–27–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–1184]
Gastrointestinal Drugs Advisory
Committee and the Pediatric Advisory
Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Gastrointestinal Drugs
Advisory Committee and the Pediatric
Advisory Committee. The general
function of the committees is to provide
advice and recommendations to FDA on
regulatory issues. The meeting will be
open to the public. FDA is establishing
a docket for public comment on this
document.
SUMMARY:
The meeting will be held on May
3, 2018, from 8 a.m. to 4:30 p.m.
ADDRESSES: DoubleTree by Hilton Hotel
Bethesda—Washington DC, Grand
Ballroom, 8120 Wisconsin Ave.,
Bethesda, MD 20814–3624. The
conference center’s telephone number is
301–652–2000. Answers to commonly
asked questions about FDA Advisory
Committee meetings may be accessed at:
https://www.fda.gov/
AdvisoryCommittees/AboutAdvisory
Committees/ucm408555.htm.
Information about the DoubleTree by
Hilton Hotel Bethesda—Washington DC
Conference Center can be accessed at:
https://doubletree3.hilton.com/en/hotels/
maryland/doubletree-by-hilton-hotelbethesda-washington-dc-WASBHDT/
index.html.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2018–N–1184.
The docket will close on May 2, 2018.
Submit either electronic or written
comments on this public meeting by
May 2, 2018. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before May 2, 2018.
The https://www.regulations.gov
electronic filing system will accept
DATES:
PO 00000
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13283
comments until midnight Eastern Time
at the end of May 2, 2018. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
Comments received on or before April
19, 2018, will be provided to the
committee. Comments received after
that date will be taken into
consideration by FDA.
You may submit comments as
follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–N–1184 for ‘‘Gastrointestinal
Drugs Advisory Committee and the
Pediatric Advisory Committee; Notice of
Meeting; Establishment of a Public
E:\FR\FM\28MRN1.SGM
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[Federal Register Volume 83, Number 60 (Wednesday, March 28, 2018)]
[Notices]
[Pages 13281-13283]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06155]
-----------------------------------------------------------------------
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) 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 (PRA).
DATES: Fax written comments on the collection of information by April
27, 2018.
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 [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: 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 13282]]
Premarket Notification for a New Dietary Ingredient--21 CFR 190.6
OMB Control Number 0910-0330--Extension
This information collection supports Agency regulations and
accompanying guidance. Specifically, 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 a new dietary ingredient, the manufacturer or distributor of
the dietary supplement or of the new dietary ingredient is to submit to
FDA (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, Sec. 190.6 (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. FDA uses 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.
FDA has developed an electronic portal that respondents may use to
electronically submit their notifications to ONLDS via FDA Unified
Registration and Listing Systems. Firms that prefer to submit a paper
notification in a format of their own choosing 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 respondent organize its NDIN to focus on the information
needed for FDA's safety review. Safety information may be submitted via
a supplemental form entitled ``New Dietary Ingredient 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 is
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. We continue to invite comment on Form FDA 3880 and the
supplemental safety information form, which may be found on our website
at https://www.fda.gov/Food/DietarySupplements/NewDietaryIngredientsNotificationProcess/default.htm.
In the Federal Register of November 17, 2017 (82 FR 54355), we
published a 60-day notice requesting public comment on the proposed
extension of this collection of information. One comment suggested ways
FDA might assist respondents by developing ``specific guidance
pertaining to the use and submission of master files to help determine
whether a dietary ingredient should be the subject of an NDIN or
exempted from notification.'' A second comment suggested 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\; (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.
---------------------------------------------------------------------------
\2\ The ``Guidance'' refers to a draft guidance published for
comment in August 2016 and available at: https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm257563.htm.
---------------------------------------------------------------------------
FDA appreciates this feedback. As noted, FDA has issued a draft
guidance on Dietary Supplements: New Dietary Ingredient Notifications
and Related Issues and will take the comment on additional guidance
into consideration when finalizing the draft guidance. As resources
allow, FDA may consider revised or additional guidance to assist
respondents to the information collection. Relatedly, with regard to
comments about costs or economic impact, FDA notes that, consistent
with our regulations at 21 CFR part 10.115 (Good Guidance Practices),
recommendations found in the draft guidance document are for comment
only. In addition, the data analysis proffered regarding costs does not
provide a basis upon which we can revise our burden estimate under the
PRA. 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 the
applicable regulatory requirements.
We therefore retain the following estimate:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR Section Number of responses per Total annual per response Total hours
respondents respondent responses (in hours)
----------------------------------------------------------------------------------------------------------------
190.6; Dietary Supplements...... 55 1 55 20 1,100
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 13283]]
We have made no adjustments to the currently approved burden
estimate for the information collection. While we have received
comments previously suggesting our burden estimate may be too low, the
comments did not discuss the basis for such a conclusion. We therefore
specifically invite individual respondent experience with the
information collection and associated collection burden.
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 assume that extracting and summarizing relevant
information from existing 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 have carefully considered the burden
associated with the premarket notification requirement and believe that
estimates greater than 20 hours are likely to include burden associated
with researching and generating safety data for a new dietary
ingredient. We believe that the burden of the premarket notification
requirement on industry is minimal 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. 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 new dietary ingredient notifications, 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.
Dated: March 22, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06155 Filed 3-27-18; 8:45 am]
BILLING CODE 4164-01-P
