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]

Download as PDF 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 VerDate Sep<11>2014 16:48 Aug 21, 2015 Jkt 235001 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 http://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 http://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 http:// 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 http://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 PO 00000 Frm 00083 Fmt 4703 Sfmt 4703 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 http://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 http:// 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 VerDate Sep<11>2014 16:48 Aug 21, 2015 Jkt 235001 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 PO 00000 Frm 00084 Fmt 4703 Sfmt 4703 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 24AUN1 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. VerDate Sep<11>2014 16:48 Aug 21, 2015 Jkt 235001 BILLING CODE 4164–01–P PO 00000 Frm 00085 Fmt 4703 Sfmt 4703 [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 24AUN1

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]


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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 http://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