
[Federal Register Volume 82, Number 23 (Monday, February 6, 2017)]
[Notices]
[Pages 9382-9383]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-02411]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0001]


Advisory Committee Nominations; Modification To Process for 
Collecting and Posting Curricula Vitae

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
modifying the process by which we collect and post curricula vitae 
(CVs) of advisory committee members so that the CVs will be posted to 
our Web site without removing or redacting any information. Posting CVs 
without removing or redacting any information will increase the 
transparency of FDA's selection of officials who serve on advisory 
committees, and will ensure greater public access to the qualifications 
of advisory committee members on an ongoing basis. Because advisory 
committee members are best situated to determine whether there is 
confidential information in their CVs, this modified collection and 
posting process will conserve FDA resources because FDA personnel will 
no longer be responsible for reviewing and redacting the CVs.

DATES: All nominees for positions on an FDA advisory committee will be 
required to submit a consent form on or after the date of the Office of 
Management and Budget (OMB) approval for this information collection, 
authorizing FDA to publicly post an un-redacted copy of their CV on 
FDA's Web site. Elsewhere in this issue of the Federal Register, FDA is 
publishing the notice for the proposed information collection. 
Additionally, effective March 8, 2017, all existing advisory committee 
members who submit an updated version of their CV to FDA will be 
required to submit a consent form along with their CV.

FOR FURTHER INFORMATION CONTACT: Questions should be sent 
electronically to ACOMSSubmissions@fda.hhs.gov, or by mail to Advisory 
Committee Oversight and Management Staff, 10903 New Hampshire Ave., 
Bldg. 32, Rm. 5129, Silver Spring, MD 20993-0002.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA generally has posted the CVs of FDA advisory committee members 
publicly on http://www.fda.gov/AdvisoryCommittees/ after reviewing the 
CVs and redacting information that appeared to be confidential. 
Currently, FDA requires the submission of a CV for each nominee as part 
of the nomination process for advisory committee members. FDA also 
requests that existing advisory committee members submit updated 
versions of their CVs, typically on a yearly basis.
    In furtherance of FDA's goal of ensuring transparency regarding the 
qualifications of individuals selected to serve on FDA advisory 
committees, and in recognition that individual advisory committee 
members are best situated to evaluate the confidentiality of 
information contained in their CVs, including any considerations raised 
by their relationships and agreements with third parties, FDA will be 
requiring that all CVs submitted as part of the nomination process for 
positions on FDA advisory committees be accompanied by a written 
consent form stating that, if the nominee is accepted as a member of an 
FDA advisory committee, the individual consents to the publication of 
the individual's CV to FDA's Web site, without FDA removing or 
redacting any information. The consent form requires that the nominee 
affirm that the CV does not include any confidential information, 
including information pertaining to third parties that the nominee is 
not permitted to disclose. A nominee will be required to submit a 
signed consent form in order for the nomination to be considered 
complete. The consent form will need to be submitted along with the 
four other types of documents currently requested as part of the 
nomination process: (1) A CV for each nominee; (2) a written 
confirmation that the nominee is aware of the nomination (unless self-
nominated); (3) a letter(s) of recommendation; and (4) for Consumer 
Representative applications, a cover letter that lists consumer or 
community organizations for which the candidate can demonstrate active 
participation. In addition to the consent form submitted as part of the 
application process, FDA will also be requiring that a nearly identical 
consent form be submitted by all existing advisory committee members 
each time they submit an updated version of their CV to FDA. The 
language of the consent for existing advisory committee members will 
differ only in that it will not include the language ``if [the nominee 
is] selected to serve on an [FDA] advisory committee''.
    Every day, FDA makes important health and safety decisions about 
foods, drugs, medical devices, cosmetics, and other widely used 
consumer products. Transparency in FDA's activities and decision making 
allows the public to better understand the Agency's decisions, 
increasing credibility and promoting accountability. Transparency helps 
the Agency to more effectively protect and promote the public health. 
Ensuring greater public awareness of the qualifications of individuals 
responsible for assisting the Agency in making important policy 
decisions is an important factor in ensuring such transparency. Posting 
the CVs of advisory committee members helps increase public awareness. 
Additionally, requiring advisory committee nominees and advisory 
committee members to attest that their CVs do not include any 
confidential information, including information pertaining to third 
parties that they are not permitted to disclose, will help conserve 
limited FDA resources by ensuring that the individual most familiar 
with the information contained in the CV, as well as any contractual or 
confidentiality agreements that might affect their ability to disclose 
that information, assumes the responsibility for determining whether 
the information may be released publicly. Because advisory committee 
nominees and members are most familiar with the information contained 
in their CVs, FDA will not be advising potential or current members 
about whether specific information in their CVs is confidential or 
otherwise should be removed.

II. Advisory Committee Member CVs and Confidential Information

    The consent form will be required to be submitted each time an 
advisory committee nominee's or existing

[[Page 9383]]

advisory committee member's CV is submitted to FDA. All information 
contained in the CV submission for individuals who are selected for or 
currently serving on an FDA advisory committee will be available for 
public posting. Specifically, for nominees for positions on an FDA 
advisory committee, the required consent will state as follows:

    If I am selected to serve on an advisory committee, I consent to 
publication of my curriculum vitae (CV), and any subsequent updates 
to my CV that I provide FDA, on FDA's Web site, without removing or 
redacting any information. My CV does not include any confidential 
information, including information pertaining to third parties that 
I am not permitted to disclose.

For existing advisory committee members who submit updated CVs, the 
required consent will state as follows:

    I consent to publication of my curriculum vitae (CV), and any 
subsequent updates to my CV that I provide FDA, on FDA's Web site, 
without removing or redacting any information. My CV does not 
include any confidential information, including information 
pertaining to third parties that I am not permitted to disclose.

III. Date of Implementation

    All nominations for new advisory committee members will be required 
to be submitted through FDA's Web site at https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm, or any 
successor system, and the submission will be required to be accompanied 
by the required consent form, on or after the date of OMB approval for 
this information collection. All updated CVs for existing advisory 
committee members will be required to be submitted to FDA along with 
the required consent form after March 8, 2017.

    Dated: February 1, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-02411 Filed 2-3-17; 8:45 am]
 BILLING CODE 4164-01-P


