80_FR_66758 80 FR 66549 - Notice of Opportunity for Public Comment on the Dietary Supplement Label Database

80 FR 66549 - Notice of Opportunity for Public Comment on the Dietary Supplement Label Database

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 209 (October 29, 2015)

Page Range66549-66549
FR Document2015-27625

The Office of Dietary Supplements (ODS) at the National Institutes of Health, in partnership with the National Library of Medicine (NLM), has developed a Dietary Supplement Label Database (DSLD) that is compiling all information from the labels of dietary supplements marketed in the United States. ODS welcomes comments about features to add and functionality improvements to make so the DSLD may become a more useful tool to users. A federal stakeholder panel for the DSLD will consider all comments received. The ODS requests input from academic researchers, government agencies, the dietary supplement industry, and other interested parties, including consumers. The DSLD can be accessed online at http:/ /dsld.nlm.nih.gov.

Federal Register, Volume 80 Issue 209 (Thursday, October 29, 2015)
[Federal Register Volume 80, Number 209 (Thursday, October 29, 2015)]
[Notices]
[Page 66549]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-27625]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Notice of Opportunity for Public Comment on the Dietary 
Supplement Label Database

SUMMARY: The Office of Dietary Supplements (ODS) at the National 
Institutes of Health, in partnership with the National Library of 
Medicine (NLM), has developed a Dietary Supplement Label Database 
(DSLD) that is compiling all information from the labels of dietary 
supplements marketed in the United States. ODS welcomes comments about 
features to add and functionality improvements to make so the DSLD may 
become a more useful tool to users.
    A federal stakeholder panel for the DSLD will consider all comments 
received. The ODS requests input from academic researchers, government 
agencies, the dietary supplement industry, and other interested 
parties, including consumers. The DSLD can be accessed online at http://dsld.nlm.nih.gov.

DATES: To ensure full consideration, all comments must be received by 
11:59 p.m. EST, November 27, 2015.

ADDRESSES: Interested individuals and organizations should submit their 
responses to [email protected].

FOR FURTHER INFORMATION CONTACT: Richard Bailen MBA, MHA., Office of 
Dietary Supplements, National Institutes of Health, 6100 Executive 
Boulevard, Room 3B01, Bethesda, MD 20892-7517, Phone: 301-435-2920, 
Fax: 301-480-1845, Email: [email protected].

SUPPLEMENTARY INFORMATION: The DSLD is a free resource that captures 
all information present on dietary supplement labels as provided by the 
seller, including contents, ingredient amounts, and any health-related 
product statements, claims, and cautions. It also provides a 
downloadable photo of each label. Users can search for and organize 
this information in various ways. Research scientists, for example, 
could use the DSLD to determine total nutrient intakes from food and 
supplements in populations they study. Health care providers can learn 
the content of products their patients are taking. Consumers might use 
the DSLD to search for and compare products of interest.
    The DSLD currently contains 50,000 labels, and it is expected to 
grow rapidly over the next three years to include most of the estimated 
75,000+ dietary supplement products sold to American consumers. The 
DSLD is updated regularly to include any formulation changes and label 
information in a product. It also includes the labels of products that 
have been discontinued and are no longer sold. More information about 
the DSLD and its current capabilities is available at http://www.dsld.nlm.nih.gov and at Dwyer et al., 2014.\1\
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    \1\ Dwyer JT, Saldanha LG, Bailen RA, et al. A free new dietary 
supplement label database for registered dietitian nutritionists. J 
Acad Nutr Diet. 2014;114(10):1512-7.
---------------------------------------------------------------------------

    ODS would like would like to receive ideas and suggestions for how 
the DSLD might evolve. What features might be added, improved, or 
enhanced--for example, in capabilities related to search, sorting, 
organization, and downloading of information--that would make it a more 
valuable tool for users?

     Dated: October 23, 2015.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2015-27625 Filed 10-28-15; 8:45 am]
 BILLING CODE 4140-01-P



                                                                                      Federal Register / Vol. 80, No. 209 / Thursday, October 29, 2015 / Notices                                                             66549

                                                    ultraviolet radiation exposure, medical                            patients will also be asked to provide a                    OMB approval is requested for 3
                                                    conditions, and other lifestyle factors                            one-time blood and buccal cell mouth                      years. There are no costs to respondents
                                                    will also be studied. Patients from 11                             wash sample and cases with lymphoma                       other than their time. The total
                                                    participating hospitals will be screened                           or leukemia will be asked to make                         estimated annualized burden hours are
                                                    and enrolled. There will be a one-time                             available a portion of their pathology                    3,262.
                                                    computer-administered interview, and                               sample.                                                   Estimated Annualized Burden Hours
                                                                                                           TABLE A.12–1—ESTIMATES OF ANNUAL BURDEN HOURS
                                                                                                                                                                                                       Time               Annual
                                                                                                                                                               Number of       Frequency of
                                                              Types of respondents                                          Instrument                                                             per response           burden
                                                                                                                                                              respondents        response             (hours)              hours

                                                    Potential Study Subjects ...................           Screening Questions ........................                2,110                 1               5/60                 176
                                                    Eligible Potential Study Subjects ......               Consent Form ..................................             1,801                 1               5/60                 150
                                                    Consented Patient Cases .................              Core Questionnaire & Occupational                             967                 1             105/60               1,692
                                                                                                             Job Module.
                                                    Consented Patient Controls ..............              Core Questionnaire & Occupational                             300                 1             105/60                  525
                                                                                                             Job Module.
                                                    Study Pathologists ............................        Pathology sample request and                                   10                97                5/60                  81
                                                                                                             tracking form.
                                                    Interviewers .......................................   Tracking forms .................................               15                85              30/60                  638


                                                      Dated: October 16, 2015.                                         FOR FURTHER INFORMATION CONTACT:                          http://www.dsld.nlm.nih.gov and at
                                                    Karla Bailey,                                                      Richard Bailen MBA, MHA., Office of                       Dwyer et al., 2014.1
                                                    Project Clearance Liaison, National Cancer                         Dietary Supplements, National                               ODS would like would like to receive
                                                    Institute, NIH.                                                    Institutes of Health, 6100 Executive                      ideas and suggestions for how the DSLD
                                                    [FR Doc. 2015–27586 Filed 10–28–15; 8:45 am]                       Boulevard, Room 3B01, Bethesda, MD                        might evolve. What features might be
                                                    BILLING CODE 4140–01–P                                             20892–7517, Phone: 301–435–2920,                          added, improved, or enhanced—for
                                                                                                                       Fax: 301–480–1845, Email:                                 example, in capabilities related to
                                                                                                                       ODS@nih.gov.                                              search, sorting, organization, and
                                                    DEPARTMENT OF HEALTH AND                                                                                                     downloading of information—that
                                                    HUMAN SERVICES                                                     SUPPLEMENTARY INFORMATION:      The DSLD                  would make it a more valuable tool for
                                                                                                                       is a free resource that captures all                      users?
                                                    National Institutes of Health                                      information present on dietary                              Dated: October 23, 2015.
                                                                                                                       supplement labels as provided by the                      Lawrence A. Tabak,
                                                    Notice of Opportunity for Public
                                                                                                                       seller, including contents, ingredient                    Deputy Director, National Institutes of Health.
                                                    Comment on the Dietary Supplement
                                                                                                                       amounts, and any health-related
                                                    Label Database                                                                                                               [FR Doc. 2015–27625 Filed 10–28–15; 8:45 am]
                                                                                                                       product statements, claims, and
                                                                                                                                                                                 BILLING CODE 4140–01–P
                                                    SUMMARY:   The Office of Dietary                                   cautions. It also provides a
                                                    Supplements (ODS) at the National                                  downloadable photo of each label. Users
                                                    Institutes of Health, in partnership with                          can search for and organize this                          DEPARTMENT OF HEALTH AND
                                                    the National Library of Medicine (NLM),                            information in various ways. Research                     HUMAN SERVICES
                                                    has developed a Dietary Supplement                                 scientists, for example, could use the
                                                    Label Database (DSLD) that is compiling                            DSLD to determine total nutrient intakes                  National Institutes of Health
                                                    all information from the labels of dietary                         from food and supplements in
                                                                                                                       populations they study. Health care                       National Institute of Allergy and
                                                    supplements marketed in the United
                                                                                                                                                                                 Infectious Diseases; Notice of Closed
                                                    States. ODS welcomes comments about                                providers can learn the content of
                                                                                                                                                                                 Meeting
                                                    features to add and functionality                                  products their patients are taking.
                                                    improvements to make so the DSLD may                               Consumers might use the DSLD to                             Pursuant to section 10(d) of the
                                                    become a more useful tool to users.                                search for and compare products of                        Federal Advisory Committee Act, as
                                                       A federal stakeholder panel for the                             interest.                                                 amended (5 U.S.C. App.), notice is
                                                    DSLD will consider all comments                                       The DSLD currently contains 50,000                     hereby given of the following meeting.
                                                    received. The ODS requests input from                              labels, and it is expected to grow rapidly                  The meeting will be closed to the
                                                    academic researchers, government                                   over the next three years to include                      public in accordance with the
                                                    agencies, the dietary supplement                                                                                             provisions set forth in sections
                                                                                                                       most of the estimated 75,000+ dietary
                                                    industry, and other interested parties,                                                                                      552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
                                                                                                                       supplement products sold to American
                                                    including consumers. The DSLD can be                                                                                         as amended. The grant applications and
                                                                                                                       consumers. The DSLD is updated                            the discussions could disclose
                                                    accessed online at http://
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                                                                                                                       regularly to include any formulation                      confidential trade secrets or commercial
                                                    dsld.nlm.nih.gov.                                                  changes and label information in a                        property such as patentable material,
                                                    DATES: To ensure full consideration, all                           product. It also includes the labels of                   and personal information concerning
                                                    comments must be received by 11:59                                 products that have been discontinued                      individuals associated with the grant
                                                    p.m. EST, November 27, 2015.                                       and are no longer sold. More
                                                                                                                       information about the DSLD and its                          1 Dwyer JT, Saldanha LG, Bailen RA, et al. A free
                                                    ADDRESSES:  Interested individuals and                             current capabilities is available at                      new dietary supplement label database for
                                                    organizations should submit their                                                                                            registered dietitian nutritionists. J Acad Nutr Diet.
                                                    responses to ODS@nih.gov.                                                                                                    2014;114(10):1512–7.



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Document Created: 2015-12-14 15:21:03
Document Modified: 2015-12-14 15:21:03
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
DatesTo ensure full consideration, all comments must be received by 11:59 p.m. EST, November 27, 2015.
ContactRichard Bailen MBA, MHA., Office of Dietary Supplements, National Institutes of Health, 6100 Executive Boulevard, Room 3B01, Bethesda, MD 20892-7517, Phone: 301-435-2920, Fax: 301-480-1845, Email: [email protected]
FR Citation80 FR 66549 

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