[Federal Register Volume 80, Number 181 (Friday, September 18, 2015)]
[Notices]
[Pages 56469-56470]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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.

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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.
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    \1\ 60 FR 66981, at 66982 (December 27, 1995).
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    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.''
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    \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.gpo.gov/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]
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