Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Notification Procedures for Statements on Dietary Supplements, 12910-12912 [2016-05478]
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12910
Federal Register / Vol. 81, No. 48 / Friday, March 11, 2016 / Notices
patient expanded access requests are
provided under § 312.310(b), and the
requirements for requesting individual
patient expanded access for emergency
use are provided under § 312.310(d).
FDA currently has OMB approval under
control number 0910–0014 for
individual patient expanded access
information collection under
§§ 312.305(b), 312.310(b), and
312.310(d). The submission
requirements concerning the use of
Form FDA 3926 for certain followup
reports are provided under §§ 312.32(c),
312.32(d), 312.33, 312.310(c)(2), 312.30,
312.41, and 312.42(e).
The estimates for ‘‘number of
respondents,’’ ‘‘number of responses per
respondent,’’ and ‘‘total annual
responses’’ were obtained from the
Center for Drug Evaluation and Research
(CDER) reports and data management
systems and from other sources familiar
with the number of submissions
received for individual patient
expanded access use under part 312.
The estimates for ‘‘average burden per
response’’ were based on information
provided by CDER and other
Department of Health and Human
Services personnel who are familiar
with preparing and reviewing expanded
access submissions by practicing
physicians.
Based on data for the number of
submissions to FDA during 2011, 2012,
and 2013, we originally estimated that
approximately 790 licensed physicians
would use Form 3926 to submit 1.46
requests per physician (respondent) for
individual patient expanded access, for
a total of 1,153 responses annually. In
response to comments received, FDA
clarifies in the final guidance and in the
form instructions that licensed
physicians may also use Form FDA
3926 for certain followup submissions.
Based on data for the number of
followup submissions during 2011,
2012, and 2013, FDA estimates that
about 790 physicians will each use
Form FDA 3926 to submit 1.57 followup
submissions per physician, for
approximately 1,241 followup responses
annually. Based on these estimates, FDA
calculates the total annual responses to
be 2,394 (1,153 requests for individual
patient expanded access and 1,241
followup submissions) by 790
physicians for an average of 3.03
responses per respondent. FDA
estimates the average burden per
response to be 45 minutes (0.75 hour).
Based on this estimate, FDA calculates
the total burden to be 1,795 hours.
Under OMB control number 0910–0014,
FDA currently has OMB approval of
17,592 hours for these submissions. The
use of FDA Form 3926 will reduce the
current burden by 15,797 hours.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Guidance on individual patient expanded access
applications: Form FDA 3926
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Expanded access submission for treatment of an individual patient, including submission of Form FDA 3926.
790
3.03
2,394
1 There
[FR Doc. 2016–05491 Filed 3–10–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0221]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Food Labeling;
Notification Procedures for Statements
on Dietary Supplements
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA 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 (the PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
SUMMARY:
asabaliauskas on DSK3SPTVN1PROD with NOTICES
0.75 (45 minutes).
Total hours
1,795
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
AGENCY:
Average
burden per
response
VerDate Sep<11>2014
17:56 Mar 10, 2016
Jkt 238001
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
invites 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 (the FD&C Act). The
notice also invites comment on a new
electronic form that allows
manufacturers, packers, and distributors
of dietary supplements to notify us via
FDA’s Unified Registration and Listing
System (FURLS).
DATES: Submit either electronic or
written comments on the collection of
information by May 10, 2016.
ADDRESSES: 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://
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
E:\FR\FM\11MRN1.SGM
11MRN1
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 81, No. 48 / Friday, March 11, 2016 / Notices
• For written/paper comments
submitted to the Division of Dockets
Management, 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–
2009–N–0221 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Food
Labeling; Notification Procedures for
Statements on Dietary Supplements.’’
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
Division of Dockets Management
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 Division of Dockets
Management. 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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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
VerDate Sep<11>2014
17:56 Mar 10, 2016
Jkt 238001
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
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, we are publishing notice of
the proposed collection of information
set forth in this document.
With respect to the following
collection of information, we invite
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of our functions, including whether the
information will have practical utility;
(2) the accuracy of our 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 its implementing
regulation, 21 CFR 101.93, require that
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. These provisions require that
we be notified, with a submission about
such statements, no later than 30 days
after the first marketing of the dietary
supplement. Information that is
required in the submission includes: (1)
PO 00000
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12911
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.
We have developed an electronic form
(Form FDA 3955) that interested
persons will be able to use to
electronically submit their notifications
to FDA via 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 a respondent to include
certain elements in their structure/
function claim notification (SFCN)
described in § 101.93 in a standard
format electronically and helps the
respondent 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 that would be 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. Draft screenshots of Form
FDA 3955 and instructions are available
for comment at https://www.fda.gov/
Food/DietarySupplements/IndustryInfo/
ucm485532.htm.
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:
E:\FR\FM\11MRN1.SGM
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Federal Register / Vol. 81, No. 48 / Friday, March 11, 2016 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section
101.93 ..................................................................
1 There
Number of
responses per
respondent
2,200
Total annual
responses
1
2,200
0.75 (45 minutes) ..........
Total hours
1,650
are no capital costs or operating and maintenance costs associated with this collection of information.
We believe that there will be minimal
burden on the industry to generate
information to meet 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. We also believe
that submission via FURLS will not
affect the burden estimates. We are
requesting only information that 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 estimate that, each year,
approximately 2,200 firms will submit
the information required by section
403(r)(6) of the FD&C Act. This estimate
is based on the average number of
notification submissions received by us
in the preceding 3 years. We estimate
that a firm will require 0.75 hours to
gather the information needed and
prepare a communication to us, for a
total of 1,650 hours (2,200 × 0.75).
competence of individual investigators,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Division of Intramural
Research Board of Scientific Counselors,
NIAID.
Date: June 6–7, 2016.
Time: 7:30 a.m. to 10:30 a.m.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: National Institutes of Health,
Building 50, Rooms 1227 and 1223, 50 Center
Drive, Rockville, MD 20852.
Contact Person: Hugh J. Auchincloss, MD,
Deputy Director, NIAID Deputy Director,
National Inst. of Allergy and Infectious
Diseases, National Institutes of Health,
Building 31, Room 7A03, MSC 2520,
Bethesda, MD 20892–2520, 301–496–9677,
auchinclossh@niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: March 7, 2016.
Leslie Kux,
Associate Commissioner for Policy.
Dated: March 7, 2016.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–05478 Filed 3–10–16; 8:45 am]
[FR Doc. 2016–05429 Filed 3–10–16; 8:45 am]
BILLING CODE 4164–01–P
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Average burden per
response
Proposed Collection; 60-Day Comment
Request; Study To Estimate Radiation
Doses and Cancer Risks From
Radioactive Fallout From the Trinity
Nuclear Test—National Cancer
Institute (NCI)
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
Division of Intramural Research Board
of Scientific Counselors, NIAID.
The meeting will be closed to the
public as indicated below in accordance
with the provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended
for the review, discussion, and
evaluation of individual intramural
programs and projects conducted by the
NATIONAL INSTITUTE OF ALLERGY
AND INFECTIOUS DISEASES,
including consideration of personnel
qualifications and performance, and the
VerDate Sep<11>2014
17:56 Mar 10, 2016
Jkt 238001
Summary: In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Cancer Institute, the National
Institutes of Health (NIH) will publish
periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Written comments and/or suggestions
from the public and affected agencies
are invited to address one or more of the
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
following points: (1) Whether the
proposed collection of information is
necessary for the proper performance of
the function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’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 those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
To Submit Comments and For Further
Information: To obtain a copy of the
data collection plans and instruments,
submit comments in writing, or request
more information on the proposed
project, contact: Steve Simon, Dosimetry
Unit Head and Staff Scientist, Radiation
Epidemiology Branch, Division of
Cancer Epidemiology & Genetics,
National Cancer Institute, NIH, 9609
Medical Center Drive, MSC9778,
Bethesda, MD 20892–9778 or call nontoll-free number (240)-276–7371 or
Email your request, including your
address to: ssimon@mail.nih.gov.
Formal requests for additional plans and
instruments must be requested in
writing.
Comment Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60 days of the date of
this publication.
Proposed Collection: Study to
Estimate Radiation Doses and Cancer
Risks from Radioactive Fallout from the
Trinity Nuclear Test, 0925–NEW, New
Submission, National Cancer Institute
(NCI), National Institutes of Health
(NIH).
Need and Use of Information
Collection: This research plan is for a
radiation-related cancer risk projection
study for the residents of the state of
New Mexico (NM) potentially exposed
to radioactive fallout from the Trinity
nuclear test conducted in 1945. Data
will be collected on diet and lifestyle
from three groups in NM (non-Hispanic
white, Hispanic, and Native American)
E:\FR\FM\11MRN1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 48 (Friday, March 11, 2016)]
[Notices]
[Pages 12910-12912]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05478]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0221]
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 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
(the 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 invites 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 (the
FD&C Act). The notice also invites comment on a new electronic form
that allows manufacturers, packers, and distributors of dietary
supplements to notify us via FDA's Unified Registration and Listing
System (FURLS).
DATES: Submit either electronic or written comments on the collection
of information by May 10, 2016.
ADDRESSES: 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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
[[Page 12911]]
For written/paper comments submitted to the Division of
Dockets Management, 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-2009-N-0221 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Food Labeling; Notification
Procedures for Statements on Dietary Supplements.'' 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 Division of Dockets Management 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 Division of Dockets Management. 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.fda.gov/regulatoryinformation/dockets/default.htm.
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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
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, we are publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, we invite
comments on these topics: (1) Whether the proposed collection of
information is necessary for the proper performance of our functions,
including whether the information will have practical utility; (2) the
accuracy of our 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 its
implementing regulation, 21 CFR 101.93, require that 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. These provisions require that we be notified, with a
submission about such statements, no later than 30 days after the first
marketing of the dietary supplement. Information that is required in
the submission includes: (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.
We have developed an electronic form (Form FDA 3955) that
interested persons will be able to use to electronically submit their
notifications to FDA via 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 a respondent to include
certain elements in their structure/function claim notification (SFCN)
described in Sec. 101.93 in a standard format electronically and helps
the respondent 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 that would be 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. Draft screenshots of Form FDA
3955 and instructions are available for comment at https://www.fda.gov/Food/DietarySupplements/IndustryInfo/ucm485532.htm.
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:
[[Page 12912]]
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........................ 2,200 1 2,200 0.75 (45 1,650
minutes).
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
We believe that there will be minimal burden on the industry to
generate information to meet 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. We also believe that submission via FURLS will not
affect the burden estimates. We are requesting only information that 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 estimate that, each year, approximately 2,200 firms
will submit the information required by section 403(r)(6) of the FD&C
Act. This estimate is based on the average number of notification
submissions received by us in the preceding 3 years. We estimate that a
firm will require 0.75 hours to gather the information needed and
prepare a communication to us, for a total of 1,650 hours (2,200 x
0.75).
Dated: March 7, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05478 Filed 3-10-16; 8:45 am]
BILLING CODE 4164-01-P
