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)
Food and Drug Administration
Federal Register Volume 80, Issue 181 (September 18, 2015)
| Page Range | 56469-56470 | |
| FR Document | 2015-23389 |
[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] ----------------------------------------------------------------------- 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. --------------------------------------------------------------------------- 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
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | 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. | |
| Contact | Kenneth R. Cohen, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3324, Silver Spring, MD 20993-0002, 301-796-7001. | |
| FR Citation | 80 FR 56469 |
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