Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling: Notification Procedures for Statements on Dietary Supplements, 68504-68506 [2021-26172]
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Federal Register / Vol. 86, No. 229 / Thursday, December 2, 2021 / Notices
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Under the
PRA (44 U.S.C. 3501–3521), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘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 provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
SUPPLEMENTARY INFORMATION:
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Tropical Disease Priority Review
Vouchers
OMB Control Number 0910–0822—
Extension
Section 524 of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
360n) is designed to encourage
development of new drug or biological
products for prevention and treatment
of certain tropical diseases affecting
millions of people throughout the world
and makes provisions for awarding
priority review vouchers for future
applications to sponsors of tropical
disease products. Section 524 of the
FD&C Act serves to stimulate new drug
development for drugs to treat a
‘‘tropical disease’’ (as defined in section
524(a)(3)) by offering additional
incentives for obtaining FDA approval
for pharmaceutical treatments for these
diseases. Under section 524 of the FD&C
Act, a sponsor of a ‘‘tropical disease
product application,’’ as defined in
section 524(a)(4), may be eligible for a
voucher that can be used to obtain a
priority review for any other application
submitted under section 505(b)(1) of the
FD&C Act (21 U.S.C. 355(b)(1)) or
section 351 of the Public Health Service
Act (PHS Act).
Accordingly, we have developed the
guidance for industry entitled ‘‘Tropical
Disease Priority Review Vouchers’’
(available at https://www.fda.gov/
media/72569/download). The guidance
explains how FDA implements
provisions of section 524 of the FD&C
Act and how sponsors may qualify for
a priority review voucher based on
eligibility criteria set forth in the statute,
how to use priority review vouchers,
and how priority review vouchers may
be transferred to other sponsors.
The guidance also communicates that,
under the FDA Reauthorization Act of
2017, section 524 requires attestation by
the sponsor of eligibility for a priority
review voucher upon submission of the
marketing application.
Description of Respondents: Sponsors
submitting applications under section
505(b)(1) of the FD&C Act or section 351
of the PHS Act.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Average
burden per
response
Total annual
responses
Total hours
Priority Review Voucher Request ........................................
Notifications of Intent to Use a Voucher ..............................
Letters Indicating the Transfer of a Voucher Letter ............
Acknowledging the Receipt of a Transferred Voucher ........
Attestation of eligibility .........................................................
4
2
2
2
4
1
1
1
1
1
4
2
2
2
4
8
8
8
8
2
32
16
16
16
8
Total ..............................................................................
........................
........................
........................
........................
88
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on our evaluation of the
information collection since last OMB
review and approval, the burden
estimate decreased based on receipt of
fewer vouchers and other information
collection activities.
lotter on DSK11XQN23PROD with NOTICES1
Number of
responses per
respondent
Number of
respondents
Information collection activity
Dated: November 24, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–26196 Filed 12–1–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–1222]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Food Labeling:
Notification Procedures for Statements
on Dietary Supplements
AGENCY:
Food and Drug Administration,
HHS.
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ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
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 of an
existing collection of information, and
SUMMARY:
E:\FR\FM\02DEN1.SGM
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Federal Register / Vol. 86, No. 229 / Thursday, December 2, 2021 / Notices
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
collection provisions of the regulation
requiring the manufacturer, packer, or
distributor of a dietary supplement to
notify us that it is marketing a dietary
supplement product that bears on its
label or in its labeling a statement
provided for in the Federal Food, Drug,
and Cosmetic Act (FD&C Act).
DATES: Submit either electronic or
written comments on the collection of
information by January 31, 2022.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before January 31,
2022. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end January 31, 2022. 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.
lotter on DSK11XQN23PROD with NOTICES1
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
VerDate Sep<11>2014
16:49 Dec 01, 2021
Jkt 256001
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–
2021–N–1222 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Food
Labeling: Notification Procedures for
Statements on Dietary Supplements.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
PO 00000
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Sfmt 4703
68505
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘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 provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Food Labeling: Notification Procedures
for Statements on Dietary
Supplements—21 CFR 101.93
OMB Control Number 0910–0331—
Extension
Section 403(r)(6) of the FD&C Act (21
U.S.C. 343(r)(6)) and § 101.93 (21 CFR
101.93) require that, no later than 30
days after the first marketing, we be
notified by the manufacturer, packer, or
distributor of a dietary supplement that
it is marketing a dietary supplement
product that bears on its label or in its
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Federal Register / Vol. 86, No. 229 / Thursday, December 2, 2021 / Notices
labeling a statement provided for in
section 403(r)(6) of the FD&C Act. In
accordance with these requirements,
submissions must include: (1) The name
and address of the manufacturer,
packer, or distributor of the dietary
supplement product; (2) the text of the
statement that is being made; (3) the
name of the dietary ingredient or
supplement that is the subject of the
statement; (4) the name of the dietary
supplement (including the brand name);
and (5) the signature of a responsible
individual or the person who can certify
the accuracy of the information
presented, and who must certify that the
information contained in the notice is
complete and accurate, and that the
notifying firm has substantiation that
the statement is truthful and not
misleading.
Our electronic form (Form FDA 3955)
allows respondents to the information
collection to electronically submit
notifications to FDA via the Food
Applications Regulatory Management
(FARM) system. 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
3955 prompts respondents to include
certain elements in their structure/
function claim notification (SFCN)
described in § 101.93 in a standard
electronic format and helps respondents
organize their SFCN to include only the
information needed for our review of
the claim. Note that the SFCN, whether
electronic or paper, is used for all
claims made pursuant to section
403(r)(6) of the FD&C Act, including
nutrient deficiency claims and general
well-being claims in addition to
structure/function claims. The
electronic form, and any optional
elements prepared as attachments to the
form (e.g., label), can be submitted in
electronic format via FARM.
Submissions of SFCNs will continue to
be allowed in paper format. We use this
information to evaluate whether
statements made for dietary ingredients
or dietary supplements are permissible
under section 403(r)(6) of the FD&C Act.
Description of Respondents:
Respondents to this collection of
information include manufacturers,
packers, or distributors of dietary
supplements that bear section 403(r)(6)
of the FD&C Act statements on their
labels or labeling.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
101.93 ..................................................................
1 There
3,690
1
Total annual
responses
3,690
Average burden per
response
0.75 (45 minutes) ...........
Total hours
2,768
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
This estimate is based on our experience
with this information collection and the
number of notifications received in the
past 3 years, which has remained
constant.
Dated: November 26, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–26172 Filed 12–1–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Solicitation of Nominations for
Membership To Serve on the National
Advisory Council on Migrant Health
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Request for nominations.
AGENCY:
lotter on DSK11XQN23PROD with NOTICES1
Number of
responses per
respondent
Number of
respondents
21 CFR section
HRSA is seeking nominations
of qualified candidates to be considered
for appointment as members of the
National Advisory Council on Migrant
Health (NACMH or advisory
committee). The NACMH advises,
SUMMARY:
VerDate Sep<11>2014
16:49 Dec 01, 2021
Jkt 256001
consults with, and makes
recommendations to the HHS Secretary
concerning the organization, operation,
selection, and funding of Migrant Health
Centers (MHCs) and other entities under
grants and contracts under the Public
Health Service (PHS) Act. HRSA is
seeking nominations to fill seven
positions on the NACMH.
DATES: HRSA will receive written
nominations for NACMH membership
on a continuous basis.
ADDRESSES: Nomination packages must
be submitted in hard copy to the
Designated Federal Official (DFO),
NACMH, Strategic Initiatives Division,
Office of Policy and Program
Development, Bureau of Primary Health
Care, HRSA, 16N38B, 5600 Fishers
Lane, Rockville, Maryland 20857.
FOR FURTHER INFORMATION CONTACT: All
requests for information regarding
NACMH nominations should be sent via
email to Esther Paul, DFO, NACMH,
HRSA at hrsabphcoppdnacmh@hrsa.gov
or 301–594–4300. The NACMH charter
and list of current membership are
available on the NACMH website at
https://bphc.hrsa.gov/quality
improvement/strategicpartnerships/
nacmh/.
SUPPLEMENTARY INFORMATION: NACMH
was established and authorized under
section 217 of the PHS Act (42 U.S.C.
218) to advise, consult with, and make
recommendations to the HHS Secretary
PO 00000
Frm 00047
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concerning the organization, operation,
selection, and funding of MHCs and
other entities under grants and contracts
under section 330(g) of the PHS Act (42
U.S.C. 254b(g)). The NACMH meets
twice each calendar year, or at the
discretion of the DFO in consultation
with the Chair.
Nominations: HRSA is requesting
nominations for voting members to
serve as Special Government Employees
(SGEs) on the NACMH to fill seven open
positions. Specifically, HRSA is
requesting nominations for the
following positions: Board Member
(three nominees), Board Member/Patient
(three nominees), and Administrator
Provider (one nominee). The Board
Member nominees must be members or
members-elect of a governing board of
an organization receiving funding under
section 330(g) of the PHS Act. The
Board Member/Patient nominees must
also be patients of the health centers
that they represent. Additionally, Board
Member nominees must be familiar with
the delivery of primary health care to
migratory and seasonal agricultural
workers (MSAWs) and their families.
The Administrator/Provider nominee
must be qualified by training and
experience in the medical sciences or in
the administration of health programs
for MSAWs and their families. Another
individual or organization may
nominate an interested applicant.
E:\FR\FM\02DEN1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 229 (Thursday, December 2, 2021)]
[Notices]
[Pages 68504-68506]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26172]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-1222]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Food Labeling: Notification Procedures for Statements
on Dietary Supplements
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. 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 of an existing collection of
information, and
[[Page 68505]]
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection provisions of
the regulation requiring the manufacturer, packer, or distributor of a
dietary supplement to notify us that it is marketing a dietary
supplement product that bears on its label or in its labeling a
statement provided for in the Federal Food, Drug, and Cosmetic Act
(FD&C Act).
DATES: Submit either electronic or written comments on the collection
of information by January 31, 2022.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before January 31, 2022. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end January 31, 2022. 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.
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-2021-N-1222 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Food Labeling: Notification
Procedures for Statements on Dietary Supplements.'' Received comments,
those filed in a timely manner (see ADDRESSES), will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``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 provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Food Labeling: Notification Procedures for Statements on Dietary
Supplements--21 CFR 101.93
OMB Control Number 0910-0331--Extension
Section 403(r)(6) of the FD&C Act (21 U.S.C. 343(r)(6)) and Sec.
101.93 (21 CFR 101.93) require that, no later than 30 days after the
first marketing, we be notified by the manufacturer, packer, or
distributor of a dietary supplement that it is marketing a dietary
supplement product that bears on its label or in its
[[Page 68506]]
labeling a statement provided for in section 403(r)(6) of the FD&C Act.
In accordance with these requirements, submissions must include: (1)
The name and address of the manufacturer, packer, or distributor of the
dietary supplement product; (2) the text of the statement that is being
made; (3) the name of the dietary ingredient or supplement that is the
subject of the statement; (4) the name of the dietary supplement
(including the brand name); and (5) the signature of a responsible
individual or the person who can certify the accuracy of the
information presented, and who must certify that the information
contained in the notice is complete and accurate, and that the
notifying firm has substantiation that the statement is truthful and
not misleading.
Our electronic form (Form FDA 3955) allows respondents to the
information collection to electronically submit notifications to FDA
via the Food Applications Regulatory Management (FARM) system. 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 3955
prompts respondents to include certain elements in their structure/
function claim notification (SFCN) described in Sec. 101.93 in a
standard electronic format and helps respondents organize their SFCN to
include only the information needed for our review of the claim. Note
that the SFCN, whether electronic or paper, is used for all claims made
pursuant to section 403(r)(6) of the FD&C Act, including nutrient
deficiency claims and general well-being claims in addition to
structure/function claims. The electronic form, and any optional
elements prepared as attachments to the form (e.g., label), can be
submitted in electronic format via FARM. Submissions of SFCNs will
continue to be allowed in paper format. We use this information to
evaluate whether statements made for dietary ingredients or dietary
supplements are permissible under section 403(r)(6) of the FD&C Act.
Description of Respondents: Respondents to this collection of
information include manufacturers, packers, or distributors of dietary
supplements that bear section 403(r)(6) of the FD&C Act statements on
their labels or labeling.
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 per response Total hours
respondents respondent responses
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101.93.................................... 3,690 1 3,690 0.75 (45 minutes)........................... 2,768
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate. This estimate is based on our experience with this
information collection and the number of notifications received in the
past 3 years, which has remained constant.
Dated: November 26, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26172 Filed 12-1-21; 8:45 am]
BILLING CODE 4164-01-P
