Agency Information Collection Activities; Proposed Collection; Comment Request; Dietary Supplement Labeling Requirements and Recommendations Under the Dietary Supplement and Nonprescription Drug Consumer Protection Act, 51278-51280 [2015-20760]
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51278
Federal Register / Vol. 80, No. 163 / Monday, August 24, 2015 / Notices
a patent infringement described in
section 351(l)(6) of the PHS Act, the
applicant is required, under section
351(l)(6)(C) of the PHS Act, to provide
the FDA with notice and a copy of the
complaint within 30 days of service.
FDA is required to publish notice of a
complaint received under section
351(l)(6)(C) of the PHS Act in the
Federal Register.
FDA has received notice of the
following complaint under section
351(l)(6)(C) of the PHS Act:
Janssen Biotech, Inc., et. al. v.
Celltrion Healthcare Co., Ltd., et al., 15–
cv–10698 (D. Mass., filed March 6,
2015).
FDA has only a ministerial role in
publishing notice of a complaint
received under section 351(l)(6)(C) of
the PHS Act, and does not perform a
substantive review of the complaint.
Dated: August 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–20780 Filed 8–21–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0001]
Science Board to the Food and Drug
Administration; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
tkelley on DSK3SPTVN1PROD with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public, via Webcast.
Name of Committee: Science Board to
the Food and Drug Administration
(Science Board).
General Function of the Committee:
The Science Board provides advice to
the Commissioner of Food and Drugs
and other appropriate officials on
specific, complex scientific and
technical issues important to the FDA
and its mission, including emerging
issues within the scientific community.
Additionally, the Science Board
provides advice to the Agency on
keeping pace with technical and
scientific developments including in
regulatory science, input into the
Agency’s research agenda, and on
upgrading its scientific and research
facilities and training opportunities. It
will also provide, where requested,
expert review of Agency sponsored
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intramural and extramural scientific
research programs.
Date and Time: The meeting will be
held on September 15, 2015, from 4
p.m. until 5:30 p.m.
Location: This meeting will take place
via Webcast. To access the link for the
Webcast check the Agency’s Web site at
https://www.fda.gov/
AdvisoryCommittees/default.htm and
scroll down to the appropriate advisory
committee meeting link. Information
regarding special accommodations due
to a disability may be accessed at
https://www.fda.gov/
AdvisoryCommittees/default.htm.
Contact Person: Rakesh Raghuwanshi,
Office of the Chief Scientist, Office of
the Commissioner, Food and Drug
Administration, Bldg. 1, Rm. 3309,
10903 New Hampshire Ave., Silver
Spring, MD 20993, 301–796–4769,
rakesh.raghuwanshi@fda.hhs.gov, or
FDA Advisory Committee Information
Line, 1–800–741–8138 (301–443–0572
in the Washington, DC area). A notice in
the Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: The Science Board will be
provided with a report from the Science
Looking Forward subcommittee.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
Background material is available at
https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before September 8, 2015.
Oral presentations from the public will
be scheduled between approximately
4:30 p.m. and 5:30 p.m. Those
individuals interested in making formal
oral presentations should notify the
contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
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requested to make their presentation on
or before September 1, 2015. Time
allotted for each presentation may be
limited. If the number of registrants
requesting to speak is greater than can
be reasonably accommodated during the
scheduled open public hearing session,
FDA may conduct a lottery to determine
the speakers for the scheduled open
public hearing session. The contact
person will notify interested persons
regarding their request to speak by
September 2, 2015.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Rakesh
Raghuwanshi at least 7 days in advance
of the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: August 18, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2015–20820 Filed 8–21–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0564]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Dietary
Supplement Labeling Requirements
and Recommendations Under the
Dietary Supplement and
Nonprescription Drug Consumer
Protection Act
AGENCY:
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
SUMMARY:
E:\FR\FM\24AUN1.SGM
24AUN1
Federal Register / Vol. 80, No. 163 / Monday, August 24, 2015 / Notices
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.
This notice solicits comments on the
information collection provisions of the
Dietary Supplement and
Nonprescription Drug Consumer
Protection Act (the DSNDCPA) and the
guidance document entitled, ‘‘Guidance
for Industry: Questions and Answers
Regarding the Labeling of Dietary
Supplements as Required by the Dietary
Supplement and Nonprescription Drug
Consumer Protection Act.’’
DATES: Submit either electronic or
written comments on the collection of
information by October 23, 2015.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
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
SUPPLEMENTARY INFORMATION:
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 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.
Dietary Supplement Labeling
Requirements and Recommendations
Under the Dietary Supplement and
Nonprescription Drug Consumer
Protection Act
OMB Control Number 0910–0642—
Extension
In 2006, the Dietary Supplement and
Nonprescription Drug Consumer
51279
Protection Act (the DSNDCPA) amended
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) with respect to
serious adverse event reporting for
dietary supplements and
nonprescription drugs marketed without
an approved application. The
DSNDCPA also amended the FD&C Act
to add section 403(y) (21 U.S.C. 343(y)),
which requires the label of a dietary
supplement marketed in the United
States to include a domestic address or
domestic telephone number through
which the product’s manufacturer,
packer, or distributor may receive a
report of a serious adverse event
associated with the dietary supplement.
In the Federal Register of September
1, 2009 (74 FR 45221), we announced
the availability of a guidance document
entitled ‘‘Guidance for Industry:
Questions and Answers Regarding the
Labeling of Dietary Supplements as
Required by the Dietary Supplement
and Nonprescription Drug Consumer
Protection Act.’’ The guidance
document contains questions and
answers related to the labeling
requirements in section 403(y) of the
FD&C Act and provides guidance to
industry on the use of an explanatory
statement before the domestic address
or telephone number. The guidance
document provides our interpretation of
the labeling requirements for section
403(y) of the FD&C Act and our views
on the information that should be
included on the label. We believe that
the guidance will enable persons to
meet the criteria for labeling that are
established in section 403(y) of the
FD&C Act.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
Activity
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
1,700
3.27
5,560
0.2
(12 minutes)
1,112
FDA recommendation for label statement explaining purpose of domestic address or phone number ...................
1,700
3.27
5,560
0.2
(12 minutes)
1,112
Total ..............................................................................
tkelley on DSK3SPTVN1PROD with NOTICES
Domestic address or phone number labeling requirement
(21 U.S.C. 343(y)) ............................................................
........................
........................
........................
........................
2,224
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The labeling requirements of section
403(y) of the FD&C Act became effective
on December 22, 2007, although we
exercised enforcement discretion until
September 30, 2010, to enable all firms
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to meet the labeling requirements for
dietary supplements. At this time,
therefore, we expect that all labels
required to include the domestic
address or telephone number pursuant
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to section 403(y) of the FD&C Act have
been revised accordingly. Thus our
current burden estimate for this
information collection applies only to
new product labels.
E:\FR\FM\24AUN1.SGM
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51280
Federal Register / Vol. 80, No. 163 / Monday, August 24, 2015 / Notices
In row 1 of table 1 we estimate the
total annual hourly burden necessary to
comply with the requirement under
section 403(y) of the FD&C Act to be
1,112 hours. Using historical A.C.
Nielson Sales Scanner Data, we estimate
the number of dietary supplement stock
keeping units for which product sales
are greater than zero to be 55,600.
Assuming that the flow of new products
is 10 percent per year, then each year
approximately 5,560 new dietary
supplement products are projected to
enter the market. Estimating that there
are 1,700 dietary supplement
manufacturers, re-packagers, re-labelers,
and holders of dietary supplements
subject to the information collection
requirement (using the figure 1,460 as
provided in our final rule of June 25,
2007 (72 FR 34752), on the ‘‘Current
Good Manufacturing Practice in
Manufacturing, Packaging, Labeling, or
Holding Operations for Dietary
Supplements,’’ and factoring for a 2
percent annual growth rate), we
calculate an annual disclosure burden of
3.27 disclosures (labels) per firm. Last,
we expect that firms prepare the
required labeling for their products in a
manner that takes into account at one
time all information required to be
disclosed and therefore believe that less
than 0.2 hours (12 minutes) per product
label would be expended to fulfill this
requirement.
In row 2 of table 1 we estimate the
total burden associated with the
recommendation to include an
explanatory statement on dietary
supplement product labels letting
consumers know the purpose of the
domestic address or telephone number
to be 1,112 hours. Based upon our
knowledge of food and dietary
supplement labeling, we estimate it
would require less than 0.2 hours (12
minutes) per product label to include
such a statement.
Notice; correction.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in theFederal
Register of Monday, August 3, 2015 (80
FR 45999). The document announced a
public workshop entitled ‘‘Surrogate
Endpoints for Clinical Trials in Kidney
Transplantation.’’ The document was
published without the email address
and fax number in the Contact Person
section and without the option for email
or phone registration in the Registration
section. This document corrects those
errors.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Ramou Pratt, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 6193, Silver Spring,
MD 20993–0002, 301–796–3928 or 301–
796–1600, FAX: 301–595–7993,
endpoints@fda.hhs.gov.
In FR Doc.
2015–18911, appearing on page 45999
in the Federal Register of Monday,
August 3, 2015, the following
corrections are made:
1. On page 45999, in the first column,
the Contact Person section is corrected
to read: ‘‘Contact Person: Ramou Pratt,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 6193, Silver Spring,
MD 20993–0002, 301–796–3928 or 301–
796–1600, FAX: 301–595–7993,
endpoints@fda.hhs.gov.’’
SUPPLEMENTARY INFORMATION:
[Docket No. FDA–2015–N–0001]
2. On page 45999, in the second
column, the Registration section is
corrected to read: ‘‘Registration: Email,
fax, or phone your registration
information (including name, title, firm
name, address, telephone and fax
numbers) to Ramou Pratt (see Contact
Person) by September 25, 2015.
Registration is free for the public
workshop. Early registration is
recommended because seating is
limited. Registration on the day of the
public workshop will be provided on a
space-available basis beginning at 8 a.m.
If you need special accommodations
because of a disability, please contact
Ramou Pratt (see Contact Person) at
least 7 days in advance.’’
Surrogate Endpoints for Clinical Trials
in Kidney Transplantation; Notice of
Public Workshop; Correction
Dated: August 19, 2015.
Leslie Kux,
Associate Commissioner for Policy.
Dated: August 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–20760 Filed 8–21–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
tkelley on DSK3SPTVN1PROD with NOTICES
ACTION:
[FR Doc. 2015–20832 Filed 8–21–15; 8:45 am]
AGENCY:
Food and Drug Administration,
HHS.
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[Document Identifier: OS–0990–0302–60D]
Agency Information Collection
Request. 60-Day Public Comment
Request
AGENCY:
Office of the Secretary, HHS.
Agency Information Collection Request.
60-Day Public Comment Request
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Office of the Secretary (OS), Department
of Health and Human Services, is
publishing the following summary of a
proposed information collection request
for public comment. Interested persons
are invited to send comments regarding
this burden estimate or any other aspect
of this collection of information,
including any of the following subjects:
(1) The necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions; (2) the accuracy of the
estimated burden; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden. To obtain copies of
the supporting statement and any
related forms for the proposed
paperwork collections referenced above,
email your request, including your
address, phone number, OMB number,
and OS document identifier, to
Sherette.funncoleman@hhs.gov, or call
the Reports Clearance Office on (202)
690–6162. Written comments and
recommendations for the proposed
information collections must be directed
to the OS Paperwork Clearance Officer
at the above email address within 60days.
Proposed Project: Medical Reserve
Corps Unit Profile and Reports
(Revision)—OMB No. 0990–0302—
Office of the Secretary/Office of the
Assistant Secretary for Health/Office of
the Surgeon General/Division of
Civilian Volunteer Medical Reserve
Corps (OS/OASH/OSG/DCVMRC) is
changed to Office of the Secretary/Office
of the Assistant Secretary for
Preparedness and Response/Office of
Emergency Management/Division of the
Civilian Volunteer Medical Reserve
Corps this reorganization was effective
as of 26 November 2014 as published in
the Federal Register [FR Doc. 2014–
28030 Filed 11–25–14; 8:45am].
Abstract: Medical Reserve Corps units
are currently located in almost 1,000
communities across the United States,
E:\FR\FM\24AUN1.SGM
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Agencies
[Federal Register Volume 80, Number 163 (Monday, August 24, 2015)]
[Notices]
[Pages 51278-51280]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20760]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0564]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Dietary Supplement Labeling Requirements and
Recommendations Under the Dietary Supplement and Nonprescription Drug
Consumer Protection Act
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
[[Page 51279]]
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. This notice
solicits comments on the information collection provisions of the
Dietary Supplement and Nonprescription Drug Consumer Protection Act
(the DSNDCPA) and the guidance document entitled, ``Guidance for
Industry: Questions and Answers Regarding the Labeling of Dietary
Supplements as Required by the Dietary Supplement and Nonprescription
Drug Consumer Protection Act.''
DATES: Submit either electronic or written comments on the collection
of information by October 23, 2015.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, 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, 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 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.
Dietary Supplement Labeling Requirements and Recommendations Under the
Dietary Supplement and Nonprescription Drug Consumer Protection Act
OMB Control Number 0910-0642--Extension
In 2006, the Dietary Supplement and Nonprescription Drug Consumer
Protection Act (the DSNDCPA) amended the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) with respect to serious adverse event
reporting for dietary supplements and nonprescription drugs marketed
without an approved application. The DSNDCPA also amended the FD&C Act
to add section 403(y) (21 U.S.C. 343(y)), which requires the label of a
dietary supplement marketed in the United States to include a domestic
address or domestic telephone number through which the product's
manufacturer, packer, or distributor may receive a report of a serious
adverse event associated with the dietary supplement.
In the Federal Register of September 1, 2009 (74 FR 45221), we
announced the availability of a guidance document entitled ``Guidance
for Industry: Questions and Answers Regarding the Labeling of Dietary
Supplements as Required by the Dietary Supplement and Nonprescription
Drug Consumer Protection Act.'' The guidance document contains
questions and answers related to the labeling requirements in section
403(y) of the FD&C Act and provides guidance to industry on the use of
an explanatory statement before the domestic address or telephone
number. The guidance document provides our interpretation of the
labeling requirements for section 403(y) of the FD&C Act and our views
on the information that should be included on the label. We believe
that the guidance will enable persons to meet the criteria for labeling
that are established in section 403(y) of the FD&C Act.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Number of disclosures Total annual Average burden
Activity respondents per disclosures per disclosure Total hours
respondent
----------------------------------------------------------------------------------------------------------------
Domestic address or phone number 1,700 3.27 5,560 0.2 1,112
labeling requirement (21 U.S.C. (12 minutes)
343(y))........................
FDA recommendation for label 1,700 3.27 5,560 0.2 1,112
statement explaining purpose of (12 minutes)
domestic address or phone
number.........................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 2,224
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The labeling requirements of section 403(y) of the FD&C Act became
effective on December 22, 2007, although we exercised enforcement
discretion until September 30, 2010, to enable all firms to meet the
labeling requirements for dietary supplements. At this time, therefore,
we expect that all labels required to include the domestic address or
telephone number pursuant to section 403(y) of the FD&C Act have been
revised accordingly. Thus our current burden estimate for this
information collection applies only to new product labels.
[[Page 51280]]
In row 1 of table 1 we estimate the total annual hourly burden
necessary to comply with the requirement under section 403(y) of the
FD&C Act to be 1,112 hours. Using historical A.C. Nielson Sales Scanner
Data, we estimate the number of dietary supplement stock keeping units
for which product sales are greater than zero to be 55,600. Assuming
that the flow of new products is 10 percent per year, then each year
approximately 5,560 new dietary supplement products are projected to
enter the market. Estimating that there are 1,700 dietary supplement
manufacturers, re-packagers, re-labelers, and holders of dietary
supplements subject to the information collection requirement (using
the figure 1,460 as provided in our final rule of June 25, 2007 (72 FR
34752), on the ``Current Good Manufacturing Practice in Manufacturing,
Packaging, Labeling, or Holding Operations for Dietary Supplements,''
and factoring for a 2 percent annual growth rate), we calculate an
annual disclosure burden of 3.27 disclosures (labels) per firm. Last,
we expect that firms prepare the required labeling for their products
in a manner that takes into account at one time all information
required to be disclosed and therefore believe that less than 0.2 hours
(12 minutes) per product label would be expended to fulfill this
requirement.
In row 2 of table 1 we estimate the total burden associated with
the recommendation to include an explanatory statement on dietary
supplement product labels letting consumers know the purpose of the
domestic address or telephone number to be 1,112 hours. Based upon our
knowledge of food and dietary supplement labeling, we estimate it would
require less than 0.2 hours (12 minutes) per product label to include
such a statement.
Dated: August 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-20760 Filed 8-21-15; 8:45 am]
BILLING CODE 4164-01-P