80_FR_56650 80 FR 56469 - Consumer Comments-Public Posting and Availability of Comments Submitted to Food and Drug Administration Dockets

80 FR 56469 - Consumer Comments-Public Posting and Availability of Comments Submitted to Food and Drug Administration Dockets

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 181 (September 18, 2015)

Page Range56469-56470
FR Document2015-23389

The Food and Drug Administration (FDA or Agency) is changing the Agency's long standing practice of not publically posting on http:/ /www.regulations.gov comments submitted by individuals in their individual capacity. These are generally comments from people who self- identify as an ``individual consumer'' under the field titled ``Category (Required)'' on the ``Your Information'' page on http:// www.regulations.gov. Changing FDA's practice to routinely post these comments, as we do other comments, will increase the transparency and public utility of FDA's public dockets. It will better enable our public dockets to function as intended: To share information and encourage an open exchange of ideas.

Federal Register, Volume 80 Issue 181 (Friday, September 18, 2015)
[Federal Register Volume 80, Number 181 (Friday, September 18, 2015)]
[Notices]
[Pages 56469-56470]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-23389]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-3230]


Consumer Comments--Public Posting and Availability of Comments 
Submitted to Food and Drug Administration Dockets

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is changing 
the Agency's long standing practice of not publically posting on http://www.regulations.gov comments submitted by individuals in their 
individual capacity. These are generally comments from people who self-
identify as an ``individual consumer'' under the field titled 
``Category (Required)'' on the ``Your Information'' page on http://www.regulations.gov. Changing FDA's practice to routinely post these 
comments, as we do other comments, will increase the transparency and 
public utility of FDA's public dockets. It will better enable our 
public dockets to function as intended: To share information and 
encourage an open exchange of ideas.

DATES: All comments submitted to any FDA docket on or after October 15, 
2015, will be publically posted, unless otherwise determined not to be 
subject to posting as described in the SUPPLEMENTARY INFORMATION 
section.

FOR FURTHER INFORMATION CONTACT: Kenneth R. Cohen, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3324, Silver 
Spring, MD 20993-0002, 301-796-7001.

SUPPLEMENTARY INFORMATION:

I. Background

    Historically, FDA generally has not publicly posted on http://www.regulations.gov comments submitted by individuals in their 
individual capacity (and not on behalf of an organization, corporation, 
or other entity). For comments submitted through http://www.regulations.gov, for example, such comments are identified as 
``Individual Consumer'' under the field titled ``Category (Required) '' 
on the ``Your Information'' page. This non-posting practice has applied 
only to individual consumer comments which otherwise would be displayed 
on http://www.regulations.gov. These comments have been placed in the 
official FDA docket and are publicly available in FDA's Reading Room or 
through Freedom of Information Act requests and have been considered by 
the Agency in finalizing its regulatory actions.
    FDA is changing this practice and will post such consumer comments 
on http://www.regulations.gov, as it posts other comments. FDA has made 
this change so that its public dockets better serve their purpose of 
promoting transparency and the sharing of information.
    In 1995, FDA explained that it routinely reviewed all comments for 
obvious confidential information before placing the comments in the 
docket (60 FR 66982), but this practice is no longer feasible given 
factors such as the volume of comments FDA receives and the adoption of 
a government-wide electronic portal system for submitting and posting 
comments at http://www.regulations.gov. FDA developed the practice of 
not posting individual consumer comments largely because of concerns 
about disclosing personal information of individuals who may not have 
realized, when submitting their comments, that their name, address, and 
other identifying information would be publicly viewable. This public 
viewability became more obvious as the Internet gained popularity and 
particularly when FDA dockets system was merged with the government-
wide portal system for submission of all public comments on government 
regulatory actions at http://www.regulations.gov in 2007. This practice 
has been precautionary because, as FDA has stated previously, ``there 
can be no reasonable expectation of confidentiality for information 
submitted to a public docket in a rulemaking proceeding.'' \1\ With the 
advent of http://www.regulations.gov,

[[Page 56470]]

FDA selected ``individual consumer'' comments for non-posting because 
of previous concerns raised by individuals and the conclusion that such 
commenters may not be as familiar with the regulatory process and the 
public nature of dockets as are other entities, such as regulated 
industry.
---------------------------------------------------------------------------

    \1\ 60 FR 66981, at 66982 (December 27, 1995).
---------------------------------------------------------------------------

    In recent years, FDA has occasionally made exceptions to this non-
posting practice, typically using the COMMENTS section in a particular 
Federal Register document to alert the public that all comments were 
subject to public posting. FDA Federal Register documents, requesting 
or providing for the submission of comments, published subsequent to 
this notice will contain new instructions and information concerning 
the posting of comments submitted to that particular docket.
    This change fulfills a recommendation from the 2010 FDA 
Transparency Initiative \2\ and aligns with a 2013 recommendation from 
the Administrative Conference of the United States that ``[a]gencies 
should manage their public rulemaking dockets to achieve maximum public 
disclosure'' consistent with legal limitations and other claims of 
privilege.\3\ It also furthers an objective in Executive Order 
13563,\4\ which directs Agencies to base their regulations on ``public 
participation and an open exchange of ideas.''
---------------------------------------------------------------------------

    \2\ ``FDA Transparency Initiative: Draft Proposals for Public 
Comment Regarding Disclosure Policies of the U.S. Food and Drug 
Administration,'' May 2010, available at www.fda.gov/AboutFDA/Transparency/PublicDisclosure (p. 4).
    \3\ Recommendation No. 2013-4, available at http://www.acus.gov/recommendation/administrative-record-informal-rulemaking.
    \4\ Executive Order 13563, available at http://www.thefederalregister.org/fdsys/pkg/FR-2011-01-21/pdf/2011-1385.pdf.
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II. Consumer Comments and Confidential Information

    The commenter is solely responsible for ensuring that the submitted 
comment does not include any confidential information that the 
commenter or a third party may not wish to be posted, such as private 
medical information, the commenter's or anyone else's Social Security 
number, or confidential business information, such as a manufacturing 
process. If a name, contact information, or other information that 
identifies the commenter is included in the body of the submitted 
comment, that information will be posted on http://www.regulations.gov. 
FDA will post comments, as well as any attachments submitted 
electronically, on http://www.regulations.gov, along with the State/
Province and country (if provided), the name of the commenter's 
representative (if any), and the category selected to identify the 
commenter (e.g., individual, consumer, academic, industry).
    The Agency expects that only in exceptional instances would a 
comment need to include private, personal, or confidential information. 
If a comment is submitted with confidential information that the 
commenter does not wish to be made available to the public, the comment 
would be submitted as a written/paper submission and in the manner 
detailed in the applicable Federal Register document. For written/paper 
comments submitted containing confidential information, FDA will post 
the redacted/blacked out version of the comment including any 
attachments submitted by the commenter. The unredacted copy will not be 
posted, assuming the commenter follows the instructions in the 
applicable Federal Register document. Any information marked as 
confidential will not be disclosed except in accordance with Sec.  
10.20 (21 CFR 10.20) and other applicable disclosure law.
    FDA will include new information and standard instructions for 
submitting comments in all Federal Register documents requesting or 
providing for the submission of comments. The instructions will explain 
how to submit comments to the docket on that particular document via 
electronic means and also will explain the process for submission of 
comments, in written/paper format, that the commenter wishes to mark as 
confidential.

III. Date of Implementation

    All comments submitted electronically through http://www.regulations.gov to any FDA docket, existing or new, after October 
15, 2015, will be posted to the applicable docket and publicly viewable 
on http://www.regulations.gov. All comments submitted by mail or 
delivery to the Division of Dockets Management in written/paper format 
to any FDA docket, existing or new, after October 15, 2015, will be 
posted to the applicable docket and publicly viewable on http://www.regulations.gov unless submitted under the following conditions: 
(1) The written/paper submission is marked as confidential, and (2) the 
submitter provides an unredacted and a redacted version; the redacted 
version must have the information claimed as confidential redacted/
blacked out. If submitted under these conditions, only the redacted/
blacked out written/paper submission will be posted publicly on http://www.regulations.gov, except as otherwise provided by Sec.  10.20 or 
other law.

    Dated: September 14, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-23389 Filed 9-17-15; 8:45 am]
BILLING CODE 4164-01-P



                                                                          Federal Register / Vol. 80, No. 181 / Friday, September 18, 2015 / Notices                                                   56469

                                              3506(c)(2)(A)) requires federal agencies                Partial Withdrawal of Previous Notice                 I. Background
                                              to publish a 30-day notice in the                         This document also withdraws a                         Historically, FDA generally has not
                                              Federal Register concerning each                        portion of a prior notice concerning the              publicly posted on http://
                                              proposed collection of information,                     same CMS–10261-specific subject                       www.regulations.gov comments
                                              including each proposed extension or                    matter.                                               submitted by individuals in their
                                              reinstatement of an existing collection                   Specifically, on page 51276, in the                 individual capacity (and not on behalf
                                              of information, before submitting the                   second column, in the second                          of an organization, corporation, or other
                                              collection to OMB for approval. To                      paragraph, information collection CMS–                entity). For comments submitted
                                              comply with this requirement, CMS is                    10261 (OMB Control Number 0938–                       through http://www.regulations.gov, for
                                              publishing this notice that summarizes                  1054) that published in the Federal                   example, such comments are identified
                                              the following proposed collection(s) of                 Register on August 24, 2015 (80 FR                    as ‘‘Individual Consumer’’ under the
                                              information for public comment:                         51275) is hereby withdrawn.                           field titled ‘‘Category (Required) ’’ on
                                                 1. Type of Information Collection                       Dated: September 15, 2015.                         the ‘‘Your Information’’ page. This non-
                                              Request: Revision of a currently                        William N. Parham, III,                               posting practice has applied only to
                                              approved collection; Title of                           Director, Paperwork Reduction Staff, Office           individual consumer comments which
                                              Information Collection: Part C Medicare                 of Strategic Operations and Regulatory                otherwise would be displayed on
                                              Advantage Reporting Requirements and                    Affairs.                                              http://www.regulations.gov. These
                                              Supporting Regulations; Use: There are                  [FR Doc. 2015–23482 Filed 9–17–15; 8:45 am]           comments have been placed in the
                                              a number of information users of Part C                 BILLING CODE 4120–01–P
                                                                                                                                                            official FDA docket and are publicly
                                              reporting data, including our central                                                                         available in FDA’s Reading Room or
                                              and regional office staff that use this                                                                       through Freedom of Information Act
                                              information to monitor health plans and                 DEPARTMENT OF HEALTH AND                              requests and have been considered by
                                              to hold them accountable for their                      HUMAN SERVICES                                        the Agency in finalizing its regulatory
                                              performance, researchers, and other                                                                           actions.
                                              government agencies such as the                         Food and Drug Administration                             FDA is changing this practice and will
                                              Government Accounting Office. Health                                                                          post such consumer comments on
                                                                                                      [Docket No. FDA–2015–N–3230]
                                              plans can use this information to                                                                             http://www.regulations.gov, as it posts
                                              measure and benchmark their                             Consumer Comments—Public Posting                      other comments. FDA has made this
                                              performance.                                            and Availability of Comments                          change so that its public dockets better
                                                 Based on internal review, this notice                Submitted to Food and Drug                            serve their purpose of promoting
                                              withdraws a portion of a prior notice                   Administration Dockets                                transparency and the sharing of
                                              (August 24, 2015) concerning the same                                                                         information.
                                                                                                      AGENCY:    Food and Drug Administration,                 In 1995, FDA explained that it
                                              subject matter and corrects that notice
                                                                                                      HHS.                                                  routinely reviewed all comments for
                                              by adding a new requirement which was
                                              inadvertently omitted from that notice.                 ACTION:   Notice.                                     obvious confidential information before
                                              Specifically, we propose to add a new                                                                         placing the comments in the docket (60
                                                                                                      SUMMARY:    The Food and Drug                         FR 66982), but this practice is no longer
                                              Payments to Providers reporting section                 Administration (FDA or Agency) is
                                              to capture data related to MA                                                                                 feasible given factors such as the
                                                                                                      changing the Agency’s long standing                   volume of comments FDA receives and
                                              organizations’ value-based payments.                    practice of not publically posting on
                                              Upon OMB approval, the Payments to                                                                            the adoption of a government-wide
                                                                                                      http://www.regulations.gov comments                   electronic portal system for submitting
                                              Providers section would add 10 data                     submitted by individuals in their
                                              elements.                                                                                                     and posting comments at http://
                                                                                                      individual capacity. These are generally              www.regulations.gov. FDA developed
                                                 HHS has developed four categories of                 comments from people who self-identify                the practice of not posting individual
                                              value based payment: (1) Fee-for-service                as an ‘‘individual consumer’’ under the               consumer comments largely because of
                                              with no link to quality; (2) fee-for-                   field titled ‘‘Category (Required)’’ on the           concerns about disclosing personal
                                              service with a link to quality; (30                     ‘‘Your Information’’ page on http://                  information of individuals who may not
                                              alternative payment models built on fee-                www.regulations.gov. Changing FDA’s                   have realized, when submitting their
                                              for-service architecture; and (4)                       practice to routinely post these                      comments, that their name, address, and
                                              population-based payment. To                            comments, as we do other comments,                    other identifying information would be
                                              compliment HHS’ action, CMS is                          will increase the transparency and                    publicly viewable. This public
                                              seeking to collect data from MA                         public utility of FDA’s public dockets.               viewability became more obvious as the
                                              organizations about the proportion of                   It will better enable our public dockets              Internet gained popularity and
                                              their payments to providers made based                  to function as intended: To share                     particularly when FDA dockets system
                                              on these four categories. The collected                 information and encourage an open                     was merged with the government-wide
                                              information would help us understand                    exchange of ideas.                                    portal system for submission of all
                                              the extent and use of alternate payment                 DATES: All comments submitted to any                  public comments on government
                                              models in the MA industry.                              FDA docket on or after October 15,                    regulatory actions at http://
                                                 Form Number: CMS–10261 (OMB                          2015, will be publically posted, unless               www.regulations.gov in 2007. This
                                              Control Number 0938–1054); Frequency:                   otherwise determined not to be subject                practice has been precautionary
                                              Yearly and semi-annually; Affected                      to posting as described in the                        because, as FDA has stated previously,
                                                                                                      SUPPLEMENTARY INFORMATION section.
tkelley on DSK3SPTVN1PROD with NOTICES




                                              Public: Private sector (business or other                                                                     ‘‘there can be no reasonable expectation
                                              for-profits); Number of Respondents:                    FOR FURTHER INFORMATION CONTACT:                      of confidentiality for information
                                              561; Total Annual Responses: 3,508;                     Kenneth R. Cohen, Food and Drug                       submitted to a public docket in a
                                              Total Annual Hours: 182,023. (For                       Administration, 10903 New Hampshire                   rulemaking proceeding.’’ 1 With the
                                              policy questions regarding this                         Ave., Bldg. 32, Rm. 3324, Silver Spring,              advent of http://www.regulations.gov,
                                              collection contact Terry Lied at 410–                   MD 20993–0002, 301–796–7001.
                                              786–8973).                                              SUPPLEMENTARY INFORMATION:                              1 60   FR 66981, at 66982 (December 27, 1995).



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                                              56470                       Federal Register / Vol. 80, No. 181 / Friday, September 18, 2015 / Notices

                                              FDA selected ‘‘individual consumer’’                    provided), the name of the commenter’s                http://www.regulations.gov, except as
                                              comments for non-posting because of                     representative (if any), and the category             otherwise provided by § 10.20 or other
                                              previous concerns raised by individuals                 selected to identify the commenter (e.g.,             law.
                                              and the conclusion that such                            individual, consumer, academic,                         Dated: September 14, 2015.
                                              commenters may not be as familiar with                  industry).                                            Leslie Kux,
                                              the regulatory process and the public                      The Agency expects that only in
                                                                                                      exceptional instances would a comment                 Associate Commissioner for Policy.
                                              nature of dockets as are other entities,
                                              such as regulated industry.                             need to include private, personal, or                 [FR Doc. 2015–23389 Filed 9–17–15; 8:45 am]
                                                In recent years, FDA has occasionally                 confidential information. If a comment                BILLING CODE 4164–01–P
                                              made exceptions to this non-posting                     is submitted with confidential
                                              practice, typically using the                           information that the commenter does
                                              COMMENTS section in a particular                        not wish to be made available to the                  DEPARTMENT OF HEALTH AND
                                              Federal Register document to alert the                  public, the comment would be                          HUMAN SERVICES
                                              public that all comments were subject to                submitted as a written/paper
                                                                                                                                                            Office of the Secretary
                                              public posting. FDA Federal Register                    submission and in the manner detailed
                                              documents, requesting or providing for                  in the applicable Federal Register                    [Document Identifier: HHS–OS–0990–0279–
                                              the submission of comments, published                   document. For written/paper comments                  30D]
                                              subsequent to this notice will contain                  submitted containing confidential
                                              new instructions and information                        information, FDA will post the                        Agency Information Collection
                                              concerning the posting of comments                      redacted/blacked out version of the                   Activities; Submission to OMB for
                                              submitted to that particular docket.                    comment including any attachments                     Review and Approval; Public Comment
                                                This change fulfills a                                submitted by the commenter. The                       Request
                                              recommendation from the 2010 FDA                        unredacted copy will not be posted,                   AGENCY:   Office of the Secretary, HHS.
                                              Transparency Initiative 2 and aligns                    assuming the commenter follows the                    ACTION:   Notice.
                                              with a 2013 recommendation from the                     instructions in the applicable Federal
                                              Administrative Conference of the                        Register document. Any information                    SUMMARY:   In compliance with section
                                              United States that ‘‘[a]gencies should                  marked as confidential will not be                    3507(a)(1)(D) of the Paperwork
                                              manage their public rulemaking dockets                  disclosed except in accordance with                   Reduction Act of 1995, the Office of the
                                              to achieve maximum public disclosure’’                  § 10.20 (21 CFR 10.20) and other                      Secretary (OS), Department of Health
                                              consistent with legal limitations and                   applicable disclosure law.                            and Human Services, has submitted an
                                              other claims of privilege.3 It also                        FDA will include new information                   Information Collection Request (ICR),
                                              furthers an objective in Executive Order                and standard instructions for submitting              described below, to the Office of
                                              13563,4 which directs Agencies to base                  comments in all Federal Register                      Management and Budget (OMB) for
                                              their regulations on ‘‘public                           documents requesting or providing for                 review and approval. The ICR is for
                                              participation and an open exchange of                   the submission of comments. The                       renewal of the approved information
                                              ideas.’’                                                instructions will explain how to submit               collection assigned OMB control
                                                                                                      comments to the docket on that                        number 0990–0279, scheduled to expire
                                              II. Consumer Comments and
                                                                                                      particular document via electronic                    on September 30, 2015. Comments
                                              Confidential Information
                                                                                                      means and also will explain the process               submitted during the first public review
                                                 The commenter is solely responsible                  for submission of comments, in written/               of this ICR will be provided to OMB.
                                              for ensuring that the submitted                         paper format, that the commenter                      OMB will accept further comments from
                                              comment does not include any                            wishes to mark as confidential.                       the public on this ICR during the review
                                              confidential information that the
                                                                                                      III. Date of Implementation                           and approval period.
                                              commenter or a third party may not
                                              wish to be posted, such as private                         All comments submitted                             DATES: Comments on the ICR must be
                                              medical information, the commenter’s                    electronically through http://                        received on or before October 19, 2015.
                                              or anyone else’s Social Security number,                www.regulations.gov to any FDA docket,                ADDRESSES: Submit your comments to
                                              or confidential business information,                   existing or new, after October 15, 2015,              OIRA_submission@omb.eop.gov or via
                                              such as a manufacturing process. If a                   will be posted to the applicable docket               facsimile to (202) 395–5806.
                                              name, contact information, or other                     and publicly viewable on http://                      FOR FURTHER INFORMATION CONTACT:
                                              information that identifies the                         www.regulations.gov. All comments                     Information Collection Clearance staff,
                                              commenter is included in the body of                    submitted by mail or delivery to the                  Information.CollectionClearance@
                                              the submitted comment, that                             Division of Dockets Management in                     hhs.gov or (202) 690–6162.
                                              information will be posted on http://                   written/paper format to any FDA                       SUPPLEMENTARY INFORMATION: When
                                              www.regulations.gov. FDA will post                      docket, existing or new, after October                submitting comments or requesting
                                              comments, as well as any attachments                    15, 2015, will be posted to the                       information, please include the OMB
                                              submitted electronically, on http://                    applicable docket and publicly viewable               control number 0990–0279 and
                                              www.regulations.gov, along with the                     on http://www.regulations.gov unless                  document identifier HHS–OS–30D for
                                              State/Province and country (if                          submitted under the following                         reference.
                                                                                                      conditions: (1) The written/paper                       Information Collection Request Title:
                                                2 ‘‘FDA Transparency Initiative: Draft Proposals
                                                                                                      submission is marked as confidential,                 Institutional Review Board Form—OMB
                                              for Public Comment Regarding Disclosure Policies
                                              of the U.S. Food and Drug Administration,’’ May
                                                                                                      and (2) the submitter provides an                     No. 0990–0279, Assistant Secretary for
tkelley on DSK3SPTVN1PROD with NOTICES




                                              2010, available at www.fda.gov/AboutFDA/                unredacted and a redacted version; the                Health, Office for Human Research
                                              Transparency/PublicDisclosure (p. 4).                   redacted version must have the                        Protections.
                                                3 Recommendation No. 2013–4, available at
                                                                                                      information claimed as confidential                     Abstract: Section 491(a) of Public Law
                                              http://www.acus.gov/recommendation/                     redacted/blacked out. If submitted                    99–158 states that the Secretary of HHS
                                              administrative-record-informal-rulemaking.
                                                4 Executive Order 13563, available at http://         under these conditions, only the                      shall by regulation require that each
                                              www.gpo.gov/fdsys/pkg/FR-2011-01-21/pdf/2011-           redacted/blacked out written/paper                    entity applying for HHS support (e.g., a
                                              1385.pdf.                                               submission will be posted publicly on                 grant, contract, or cooperative


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Document Created: 2015-12-15 09:27:38
Document Modified: 2015-12-15 09:27:38
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
ActionNotice.
DatesAll comments submitted to any FDA docket on or after October 15, 2015, will be publically posted, unless otherwise determined not to be subject to posting as described in the SUPPLEMENTARY INFORMATION section.
ContactKenneth R. Cohen, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3324, Silver Spring, MD 20993-0002, 301-796-7001.
FR Citation80 FR 56469 

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