Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Dietary Supplement Labeling Requirements and Recommendations Under the Dietary Supplement and Nonprescription Drug Consumer Protection Act, 70237-70238 [2015-28788]
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70237
Federal Register / Vol. 80, No. 219 / Friday, November 13, 2015 / Notices
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
Dated: November 5, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–28789 Filed 11–12–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration
[Docket No. FDA–2012–N–0564]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Dietary
Supplement Labeling Requirements
and Recommendations Under the
Dietary Supplement and
Nonprescription Drug Consumer
Protection Act
AGENCY:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Food and Drug Administration,
HHS.
ACTION:
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0642. Also
include the FDA docket number found
in brackets in the heading of this
document.
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by December
14, 2015.
ADDRESSES: To ensure that comments on
the information collection are received,
SUMMARY:
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.
In the Federal Register of August 24,
2015 (80 FR 51278), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
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
Average
burden per
disclosure
Total annual
disclosures
Total hours
Domestic address or phone number labeling requirement
(21 U.S.C. 343(y)) ............................................................
FDA recommendation for label statement explaining purpose of domestic address or phone number ...................
1,700
3.27
5,560
0.2
1,112
1,700
3.27
5,560
0.2
1,112
Total ..............................................................................
........................
........................
........................
........................
2,224
jstallworth on DSK7TPTVN1PROD with NOTICES
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 issued in
section 403(y) have been revised
VerDate Sep<11>2014
17:57 Nov 12, 2015
Jkt 238001
accordingly. Thus our current burden
estimate for this information collection
applies only to new product labels.
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 (21
U.S.C. 343(y)) to be 1,112 hours. Using
historical A.C. Nielson Sales Scanner
Data, we estimate the number of dietary
supplement SKUs for which product
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
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
E:\FR\FM\13NON1.SGM
13NON1
70238
Federal Register / Vol. 80, No. 219 / Friday, November 13, 2015 / Notices
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 two
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: November 5, 2015.
Leslie Kux,
Associate Commissioner for Policy.
Information requests can also be
submitted by email to DCAS@CDC.GOV.
SUPPLEMENTARY INFORMATION:
Authority: 42 CFR 83.9–83.12.
Pursuant to 42 CFR 83.12, the initial
proposed definition for the class being
evaluated, subject to revision as
warranted by the evaluation, is as
follows:
Facility: Battelle King Avenue.
Location: Columbus, Ohio.
Job Titles and/or Job Duties: All
Atomic Weapons Employees who
worked at the facility owned by the
Battelle Laboratories at the King Avenue
site in Columbus, Ohio, during the
period from July 1, 1956 through
December 31, 1970, for a number of
work days aggregating at least 250 work
days, occurring either solely under this
employment or in combination with
work days within the parameters
established for one or more other classes
of employees in the Special Exposure
Cohort.
Period of Employment: July 1, 1956
through December 31, 1970.
John Howard,
Director, National Institute for Occupational
Safety and Health.
[FR Doc. 2015–28905 Filed 11–12–15; 8:45 am]
BILLING CODE 4163–19–P
[FR Doc. 2015–28788 Filed 11–12–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Agenda: IC Director reports and any other
committee business.
Place: National Institutes of Health,
Building 31, 6th Floor, Conference Room
6C6, 31 Center Drive, Bethesda, MD 20892
Contact Person: Gretchen Wood, Staff
Assistant, National Institutes of Health,
Office of the Director, One Center Drive,
Building 1, Room 126, Bethesda, MD 20892,
301–496–4272, woodgs@od.nih.gov.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit.
Information is also available on the
Institute’s/Center’s home page: https://
acd.od.nih.gov, where an agenda and any
additional information for the meeting will
be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.14, Intramural Research
Training Award; 93.22, Clinical Research
Loan Repayment Program for Individuals
from Disadvantaged Backgrounds; 93.232,
Loan Repayment Program for Research
Generally; 93.39, Academic Research
Enhancement Award; 93.936, NIH Acquired
Immunodeficiency Syndrome Research Loan
Repayment Program; 93.187, Undergraduate
Scholarship Program for Individuals from
Disadvantaged Backgrounds, National
Institutes of Health, HHS)
Dated: November 6, 2015.
Anna Snouffer,
Deputy Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–28797 Filed 11–12–15; 8:45 am]
Decision To Evaluate a Petition To
Designate a Class of Employees From
the Battelle King Avenue Site in
Columbus, Ohio, To Be Included in the
Special Exposure Cohort
National Institute for
Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention, Department of Health
and Human Services.
ACTION: Notice.
AGENCY:
NIOSH gives notice of a
decision to evaluate a petition to
designate a class of employees from the
Battelle King Avenue site in Columbus,
Ohio, to be included in the Special
Exposure Cohort under the Energy
Employees Occupational Illness
Compensation Program Act of 2000.
FOR FURTHER INFORMATION CONTACT:
Stuart L. Hinnefeld, Director, Division
of Compensation Analysis and Support,
National Institute for Occupational
Safety and Health, 1090 Tusculum
Avenue, MS C–46, Cincinnati, OH
45226–1938, Telephone 877–222–7570.
jstallworth on DSK7TPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
15:03 Nov 12, 2015
Jkt 238001
Office of the Director, National
Institutes of Health; Notice of Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
Advisory Committee to the Director,
National Institutes of Health.
The meeting will be open to the
public, with attendance limited to space
available. Individuals who plan to
attend and need special assistance, such
as sign language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
Name of Committee: Advisory Committee
to the Director, National Institutes of Health.
Date: December 10–11, 2015.
Time: December 10, 2015, 9:00 a.m. to 5:00
p.m.
Agenda: NIH Director’s report and ACD
Working Group reports.
Place: National Institutes of Health,
Building 31, 6th Floor, Conference Room
6C6, 31 Center Drive, Bethesda, MD 20892.
Time: December 11, 2015, 9:00 a.m. to
Adjournment
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Fmt 4703
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BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute On Aging; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
E:\FR\FM\13NON1.SGM
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]]>Agencies
[Federal Register Volume 80, Number 219 (Friday, November 13, 2015)]
[Notices]
[Pages 70237-70238]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-28788]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0564]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by
December 14, 2015.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0642.
Also include the FDA 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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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.
In the Federal Register of August 24, 2015 (80 FR 51278), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of disclosures Total annual Average burden Total hours
respondents per respondent disclosures per disclosure
----------------------------------------------------------------------------------------------------------------
Domestic address or phone number 1,700 3.27 5,560 0.2 1,112
labeling requirement (21 U.S.C.
343(y))........................
FDA recommendation for label 1,700 3.27 5,560 0.2 1,112
statement explaining purpose of
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 issued in section 403(y) have been revised
accordingly. Thus our current burden estimate for this information
collection applies only to new product labels.
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 (21 U.S.C. 343(y)) to be 1,112 hours. Using historical A.C.
Nielson Sales Scanner Data, we estimate the number of dietary
supplement SKUs 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
[[Page 70238]]
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 two 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: November 5, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-28788 Filed 11-12-15; 8:45 am]
BILLING CODE 4164-01-P
