80 FR 70237 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 219 (November 13, 2015)

Page Range		70237-70238
FR Document		2015-28788

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.

Federal Register, Volume 80 Issue 219 (Friday, November 13, 2015)

[Federal Register Volume 80, Number 219 (Friday, November 13, 2015)]
[Notices]
[Pages 70237-70238]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-28788]


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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 [email protected]. 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, [email protected].

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

Federal Register / Vol. 80, No. 219 / Friday, November 13, 2015 / Notices 70237

information collection is available on OMB recommends that written supplement marketed in the United
the Internet at http://www.reginfo.gov/ comments be faxed to the Office of States to include a domestic address or
public/do/PRAMain. Information and Regulatory Affairs, domestic telephone number through
Dated: November 5, 2015. OMB, Attn: FDA Desk Officer, FAX: which the product’s manufacturer,
Leslie Kux, 202–395–7285, or emailed to oira_ packer or distributor may receive a
Associate Commissioner for Policy.
submission@omb.eop.gov. All report of a serious adverse event
comments should be identified with the associated with the dietary supplement.
[FR Doc. 2015–28789 Filed 11–12–15; 8:45 am]
OMB control number 0910–0642. Also
BILLING CODE 4164–01–P In the Federal Register of September
include the FDA docket number found
1, 2009 (74 FR 45221), we announced
in brackets in the heading of this
document. the availability of a guidance document
DEPARTMENT OF HEALTH AND entitled, ‘‘Guidance for Industry:
HUMAN SERVICES FOR FURTHER INFORMATION CONTACT: FDA Questions and Answers Regarding the
PRA Staff, Office of Operations, Food Labeling of Dietary Supplements as
Food and Drug Administration and Drug Administration, 8455 Required by the Dietary Supplement
[Docket No. FDA–2012–N–0564] Colesville Rd., COLE–14526, Silver and Nonprescription Drug Consumer
Spring, MD 20993–0002, PRAStaff@ Protection Act.’’ The guidance
Agency Information Collection fda.hhs.gov. document contains questions and
Activities; Submission for Office of answers related to the labeling
SUPPLEMENTARY INFORMATION: In
Management and Budget Review; requirements in section 403(y) of the
compliance with 44 U.S.C. 3507, FDA
Comment Request; Dietary FD&C Act and provides guidance to
has submitted the following proposed
Supplement Labeling Requirements
collection of information to OMB for industry on the use of an explanatory
and Recommendations Under the
review and clearance. statement before the domestic address
Dietary Supplement and
or telephone number. The guidance
Nonprescription Drug Consumer Dietary Supplement Labeling
Protection Act document provides our interpretation of
Requirements and Recommendations
the labeling requirements for section
Under the Dietary Supplement and
AGENCY: Food and Drug Administration, 403(y) of the FD&C Act and our views
Nonprescription Drug Consumer
HHS. on the information that should be
Protection Act—(OMB Control Number
ACTION: Notice. 0910–0642)–Extension included on the label. We believe that
the guidance will enable persons to
SUMMARY: The Food and Drug In 2006, the Dietary Supplement and meet the criteria for labeling that are
Administration (FDA) is announcing Nonprescription Drug Consumer established in section 403(y) of the
that a proposed collection of Protection Act (the DSNDCPA) amended FD&C Act.
information has been submitted to the the Federal Food, Drug, and Cosmetic
Office of Management and Budget In the Federal Register of August 24,
Act (the FD&C Act) with respect to
(OMB) for review and clearance under serious adverse event reporting for 2015 (80 FR 51278), FDA published a
the Paperwork Reduction Act of 1995. dietary supplements and 60-day notice requesting public
DATES: Fax written comments on the nonprescription drugs marketed without comment on the proposed collection of
collection of information by December an approved application. The information. No comments were
14, 2015. DSNDCPA also amended the FD&C Act received.
ADDRESSES: To ensure that comments on to add section 403(y) (21 U.S.C. 343(y)), We estimate the burden of this
the information collection are received, which requires the label of a dietary collection of information as follows:

TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average
Number of disclosures Total annual
Activity burden per Total hours
respondents per disclosures disclosure
respondent

Domestic address or phone number labeling requirement
(21 U.S.C. 343(y)) ............................................................ 1,700 3.27 5,560 0.2 1,112
FDA recommendation for label statement explaining pur-
pose of domestic address or phone number ................... 1,700 3.27 5,560 0.2 1,112

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 accordingly. Thus our current burden sales are greater than zero to be 55,600.
403(y) of the FD&C Act became effective estimate for this information collection Assuming that the flow of new products
on December 22, 2007, although we applies only to new product labels. is 10 percent per year, then each year
In row 1 of Table 1 we estimate the
jstallworth on DSK7TPTVN1PROD with NOTICES

exercised enforcement discretion until approximately 5,560 new dietary
September 30, 2010, to enable all firms total annual hourly burden necessary to supplement products are projected to
to meet the labeling requirements for comply with the requirement under enter the market. Estimating that there
dietary supplements. At this time, section 403(y) of the FD&C Act (21 are 1,700 dietary supplement
therefore, we expect that all labels U.S.C. 343(y)) to be 1,112 hours. Using manufacturers, re-packagers, re-labelers,
required to include the domestic historical A.C. Nielson Sales Scanner and holders of dietary supplements
address or telephone number issued in Data, we estimate the number of dietary subject to the information collection
section 403(y) have been revised supplement SKUs for which product requirement (using the figure 1,460 as

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70238 Federal Register / Vol. 80, No. 219 / Friday, November 13, 2015 / Notices

provided in our final rule of June 25, Information requests can also be Agenda: IC Director reports and any other
2007 (72 FR 34752) on the Current Good submitted by email to DCAS@CDC.GOV. committee business.
Manufacturing Practice in Place: National Institutes of Health,
SUPPLEMENTARY INFORMATION:
Manufacturing, Packaging, Labeling, or Building 31, 6th Floor, Conference Room
Authority: 42 CFR 83.9–83.12. 6C6, 31 Center Drive, Bethesda, MD 20892
Holding Operations for Dietary Contact Person: Gretchen Wood, Staff
Supplements, and factoring for a two Pursuant to 42 CFR 83.12, the initial Assistant, National Institutes of Health,
percent annual growth rate), we proposed definition for the class being Office of the Director, One Center Drive,
calculate an annual disclosure burden of evaluated, subject to revision as Building 1, Room 126, Bethesda, MD 20892,
3.27 disclosures (labels) per firm. Last, warranted by the evaluation, is as 301–496–4272, woodgs@od.nih.gov.
we expect that firms prepare the follows: In the interest of security, NIH has
required labeling for their products in a Facility: Battelle King Avenue. instituted stringent procedures for entrance
manner that takes into account at one Location: Columbus, Ohio. onto the NIH campus. All visitor vehicles,
time all information required to be including taxicabs, hotel, and airport shuttles
Job Titles and/or Job Duties: All
disclosed and therefore believe that less will be inspected before being allowed on
Atomic Weapons Employees who campus. Visitors will be asked to show one
than 0.2 hours (12 minutes) per product worked at the facility owned by the form of identification (for example, a
label would be expended to fulfill this Battelle Laboratories at the King Avenue government-issued photo ID, driver’s license,
requirement. site in Columbus, Ohio, during the or passport) and to state the purpose of their
In row 2 of Table 1 we estimate the period from July 1, 1956 through visit.
total burden associated with the December 31, 1970, for a number of Information is also available on the
recommendation to include an work days aggregating at least 250 work Institute’s/Center’s home page: http://
explanatory statement on dietary days, occurring either solely under this acd.od.nih.gov, where an agenda and any
supplement product labels letting additional information for the meeting will
employment or in combination with
be posted when available.
consumers know the purpose of the work days within the parameters
domestic address or telephone number (Catalogue of Federal Domestic Assistance
established for one or more other classes
Program Nos. 93.14, Intramural Research
to be 1,112 hours. Based upon our of employees in the Special Exposure Training Award; 93.22, Clinical Research
knowledge of food and dietary Cohort. Loan Repayment Program for Individuals
supplement labeling, we estimate it Period of Employment: July 1, 1956 from Disadvantaged Backgrounds; 93.232,
would require less than 0.2 hours (12 through December 31, 1970. Loan Repayment Program for Research
minutes) per product label to include Generally; 93.39, Academic Research
such a statement. John Howard, Enhancement Award; 93.936, NIH Acquired
Director, National Institute for Occupational Immunodeficiency Syndrome Research Loan
Dated: November 5, 2015. Safety and Health. Repayment Program; 93.187, Undergraduate
Leslie Kux, [FR Doc. 2015–28905 Filed 11–12–15; 8:45 am] Scholarship Program for Individuals from
Associate Commissioner for Policy. BILLING CODE 4163–19–P Disadvantaged Backgrounds, National
[FR Doc. 2015–28788 Filed 11–12–15; 8:45 am] Institutes of Health, HHS)
BILLING CODE 4164–01–P
Dated: November 6, 2015.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES Anna Snouffer,
DEPARTMENT OF HEALTH AND Deputy Director, Office of Federal Advisory
HUMAN SERVICES National Institutes of Health Committee Policy.
[FR Doc. 2015–28797 Filed 11–12–15; 8:45 am]
Decision To Evaluate a Petition To Office of the Director, National BILLING CODE 4140–01–P
Designate a Class of Employees From Institutes of Health; Notice of Meeting
the Battelle King Avenue Site in
Columbus, Ohio, To Be Included in the Pursuant to section 10(a) of the DEPARTMENT OF HEALTH AND
Special Exposure Cohort Federal Advisory Committee Act, as HUMAN SERVICES
amended (5 U.S.C. App.), notice is
AGENCY: National Institute for hereby given of a meeting of the National Institutes of Health
Occupational Safety and Health Advisory Committee to the Director,
(NIOSH), Centers for Disease Control National Institutes of Health. National Institute On Aging; Notice of
and Prevention, Department of Health The meeting will be open to the Closed Meeting
and Human Services. public, with attendance limited to space
ACTION: Notice. available. Individuals who plan to Pursuant to section 10(d) of the
attend and need special assistance, such Federal Advisory Committee Act, as
SUMMARY: NIOSH gives notice of a as sign language interpretation or other amended (5 U.S.C. App.), notice is
decision to evaluate a petition to reasonable accommodations, should hereby given of the following meeting.
designate a class of employees from the notify the Contact Person listed below The meeting will be closed to the
Battelle King Avenue site in Columbus, in advance of the meeting. public in accordance with the
Ohio, to be included in the Special Name of Committee: Advisory Committee provisions set forth in sections
Exposure Cohort under the Energy to the Director, National Institutes of Health. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
Employees Occupational Illness Date: December 10–11, 2015. as amended. The grant applications and
Compensation Program Act of 2000. Time: December 10, 2015, 9:00 a.m. to 5:00 the discussions could disclose
jstallworth on DSK7TPTVN1PROD with NOTICES

FOR FURTHER INFORMATION CONTACT: p.m. confidential trade secrets or commercial
Stuart L. Hinnefeld, Director, Division Agenda: NIH Director’s report and ACD property such as patentable material,
Working Group reports.
of Compensation Analysis and Support, Place: National Institutes of Health,
and personal information concerning
National Institute for Occupational Building 31, 6th Floor, Conference Room individuals associated with the grant
Safety and Health, 1090 Tusculum 6C6, 31 Center Drive, Bethesda, MD 20892. applications, the disclosure of which
Avenue, MS C–46, Cincinnati, OH Time: December 11, 2015, 9:00 a.m. to would constitute a clearly unwarranted
45226–1938, Telephone 877–222–7570. Adjournment invasion of personal privacy.

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Document Created: 2018-03-01 11:22:57
Document Modified: 2018-03-01 11:22:57

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Fax written comments on the collection of information by December 14, 2015.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation		80 FR 70237

80 FR 70237 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 219 (November 13, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration