Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Notification Procedures for Statements on Dietary Supplements, 2528-2530 [2019-01380]

Download as PDF 2528 Federal Register / Vol. 84, No. 26 / Thursday, February 7, 2019 / Notices • 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–D–1334 for ‘‘Opioid Use Disorder: Developing Depot Buprenorphine Products for Treatment.’’ Received comments 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. • 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.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 VerDate Sep<11>2014 17:23 Feb 06, 2019 Jkt 247001 Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Silvana Borges, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 3200, Silver Spring, MD 20993–0002, 301– 796–0963. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry entitled ‘‘Opioid Use Disorder: Developing Depot Buprenorphine Products for Treatment.’’ This guidance reflects the Agency’s current thinking regarding drug product development and trial design issues relevant to the study of depot buprenorphine products (i.e., modified-release products for injection or implantation) for the treatment of opioid use disorder. Passive-compliance formulations such as sustained-release injectable depots and implants can provide effective treatment of opioid use disorder in a treatment paradigm that may be less subject to misuse, abuse, or accidental exposure compared to selfadministered formulations such as transmucosal tablets and films. This finalizes the draft guidance entitled ‘‘Opioid Dependence: Developing Depot Buprenorphine Products for Treatment’’ issued on April 23, 2018 (83 FR 17666). In addition to editorial changes made primarily for clarification, changes from the draft to the final guidance include replacement of opioid dependence with opioid use disorder, the addition of language noting that patients with moderate-severe opioid use disorder should be enrolled in clinical trials, and clarification of the cumulative responder curve efficacy analysis. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ‘‘Opioid Use Disorder: Developing Depot Buprenorphine Products for PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 Treatment.’’ It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866. II. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The collections of information in 21 CFR parts 312 and 314 have been approved under OMB control numbers 0910–0014 and 0910– 0001, respectively. The collection of information in 21 CFR parts 50 and 56 have been approved under OMB control numbers 0910–0755 and 0910–0130. III. Electronic Access Persons with access to the internet may obtain the guidance at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. Dated: January 24, 2019. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2019–01517 Filed 2–6–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0032] 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. The Food and Drug Administration (FDA or Agency) 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 to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of the regulation SUMMARY: E:\FR\FM\07FEN1.SGM 07FEN1 Federal Register / Vol. 84, No. 26 / Thursday, February 7, 2019 / Notices 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 (the FD&C Act). DATES: Submit either electronic or written comments on the collection of information by April 8, 2019. 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 April 8, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of April 8, 2019. 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 VerDate Sep<11>2014 17:23 Feb 06, 2019 Jkt 247001 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– 2013–N–0032 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. • 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.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.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. PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 2529 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. SUPPLEMENTARY INFORMATION: Under the 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. ‘‘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, we invite comment 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) of our regulations 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 labeling a statement provided for in section 403(r)(6) of the FD&C Act. In accordance with these E:\FR\FM\07FEN1.SGM 07FEN1 2530 Federal Register / Vol. 84, No. 26 / Thursday, February 7, 2019 / Notices 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 FDA Unified Registration 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 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 FURLS. 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 Number of responses per respondent Number of respondents 21 CFR section 3,690 Average burden per response Total annual responses 1 3,690 0.75 (45 minutes) ............................. Total hours 2,767.5 are no capital costs or operating and maintenance costs associated with this collection of information. Our burden estimate reflects an overall increase of 1,117.5 hours (from 1,650 hours) and a corresponding increase of 1,490 responses (from 2,200 responses). We attribute this adjustment to an increase in the average number of notification submissions we received over the preceding 12 months, which we expect will continue over the next 3 years. We believe gathering information to satisfy the notification requirements of section 403(r)(6) of the FD&C Act by submitting information regarding section 403(r)(6) of the FD&C Act statements on labels or in labeling of dietary supplements imposes minimal burden on respondents. We expect the information needed is immediately available to the manufacturer, packer, or distributor of the dietary supplement that bears such a statement on its label or in its labeling. We believe also that submission via FURLS will facilitate reporting for respondents. We estimate that, each year, approximately 3,690 firms will submit the information required by section 403(r)(6) of the FD&C Act. Assuming firms require 0.75 hours to gather the information needed and prepare a communication, we calculate a total of 2,767.5 hours (3,690 total annual responses × 0.75 hours). Dated: February 1, 2019. Lowell J. Schiller, Acting Associate Commissioner for Policy. [FR Doc. 2019–01380 Filed 2–6–19; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 17:23 Feb 06, 2019 Jkt 247001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–N–0125] Oncologic Drugs 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 Oncologic Drugs Advisory Committee. The general function of the committee 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 February 26, 2019, from 12:30 p.m. to 5 p.m. ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993–0002. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/ DATES: PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 AdvisoryCommittees/AboutAdvisory Committees/ucm408555.htm. FDA is establishing a docket for public comment on this meeting. The docket number is FDA–2019–N–0125. The docket will close on February 25, 2019. Submit either electronic or written comments on this public meeting by February 25, 2019. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before February 25, 2019. The https:// www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of February 25, 2019. 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 February 22, 2019, 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, E:\FR\FM\07FEN1.SGM 07FEN1

Agencies

[Federal Register Volume 84, Number 26 (Thursday, February 7, 2019)]
[Notices]
[Pages 2528-2530]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01380]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0032]

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 or Agency) 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
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection provisions of
the regulation

[[Page 2529]]

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 (the FD&C Act).

DATES: Submit either electronic or written comments on the collection
of information by April 8, 2019.

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 April 8, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 8, 2019. 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-2013-N-0032 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.
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.gpo.gov/fdsys/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.

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.

SUPPLEMENTARY INFORMATION: Under the 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.
``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, we invite
comment 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) of our regulations 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 labeling a
statement provided for in section 403(r)(6) of the FD&C Act. In
accordance with these

[[Page 2530]]

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 FDA Unified Registration 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 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 FURLS. 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
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
101.93........................ 3,690 1 3,690 0.75 (45 2,767.5
minutes).
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

Our burden estimate reflects an overall increase of 1,117.5 hours
(from 1,650 hours) and a corresponding increase of 1,490 responses
(from 2,200 responses). We attribute this adjustment to an increase in
the average number of notification submissions we received over the
preceding 12 months, which we expect will continue over the next 3
years. We believe gathering information to satisfy the notification
requirements of section 403(r)(6) of the FD&C Act by submitting
information regarding section 403(r)(6) of the FD&C Act statements on
labels or in labeling of dietary supplements imposes minimal burden on
respondents. We expect the information needed is immediately available
to the manufacturer, packer, or distributor of the dietary supplement
that bears such a statement on its label or in its labeling. We believe
also that submission via FURLS will facilitate reporting for
respondents. We estimate that, each year, approximately 3,690 firms
will submit the information required by section 403(r)(6) of the FD&C
Act. Assuming firms require 0.75 hours to gather the information needed
and prepare a communication, we calculate a total of 2,767.5 hours
(3,690 total annual responses x 0.75 hours).

Dated: February 1, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-01380 Filed 2-6-19; 8:45 am]
BILLING CODE 4164-01-P

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