82 FR 9382 - Advisory Committee Nominations; Modification To Process for Collecting and Posting Curricula Vitae
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 23 (February 6, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 23 (February 6, 2017)
| Page Range | 9382-9383 | |
| FR Document | 2017-02411 |
[Federal Register Volume 82, Number 23 (Monday, February 6, 2017)] [Notices] [Pages 9382-9383] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-02411] ======================================================================= ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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
![9382 Federal Register / Vol. 82, No. 23 / Monday, February 6, 2017 / Notices
Minnesota, and thereby indirectly approval for this information collection, CV for each nominee; (2) a written
acquire Signature Bank, Minnetonka, authorizing FDA to publicly post an un- confirmation that the nominee is aware
Minnesota. redacted copy of their CV on FDA’s Web of the nomination (unless self-
B. Federal Reserve Bank of San site. Elsewhere in this issue of the nominated); (3) a letter(s) of
Francisco (Gerald C. Tsai, Director, Federal Register, FDA is publishing the recommendation; and (4) for Consumer
Applications and Enforcement) 101 notice for the proposed information Representative applications, a cover
Market Street, San Francisco, California collection. Additionally, effective March letter that lists consumer or community
94105–1579: 8, 2017, all existing advisory committee organizations for which the candidate
1. Carpenter Bank Partners, Inc., members who submit an updated can demonstrate active participation. In
CCFW, Inc., Carpenter Fund Manager version of their CV to FDA will be addition to the consent form submitted
GP, LLC, Carpenter Fund Management required to submit a consent form along as part of the application process, FDA
Company, LLC, Carpenter Community with their CV. will also be requiring that a nearly
BancFund, L.P., Carpenter Community FOR FURTHER INFORMATION CONTACT: identical consent form be submitted by
BancFund-A, L.P., and Carpenter Questions should be sent electronically all existing advisory committee
Community BancFund, L.P., all Irvine, to ACOMSSubmissions@fda.hhs.gov, or members each time they submit an
California; to acquire Pacific Premier by mail to Advisory Committee updated version of their CV to FDA. The
Bancorp and thereby indirectly acquire Oversight and Management Staff, 10903 language of the consent for existing
Pacific Premier Bank, Irvine, California. New Hampshire Ave., Bldg. 32, Rm. advisory committee members will differ
Board of Governors of the Federal Reserve 5129, Silver Spring, MD 20993–0002. only in that it will not include the
System, January 31, 2017. language ‘‘if [the nominee is] selected to
SUPPLEMENTARY INFORMATION:
Yao-Chin Chao,
serve on an [FDA] advisory committee’’.
I. Background Every day, FDA makes important
Assistant Secretary of the Board.
health and safety decisions about foods,
[FR Doc. 2017–02368 Filed 2–3–17; 8:45 am] FDA generally has posted the CVs of
drugs, medical devices, cosmetics, and
FDA advisory committee members
BILLING CODE 6210–01–P other widely used consumer products.
publicly on http://www.fda.gov/
Transparency in FDA’s activities and
AdvisoryCommittees/ after reviewing decision making allows the public to
DEPARTMENT OF HEALTH AND the CVs and redacting information that better understand the Agency’s
HUMAN SERVICES appeared to be confidential. Currently, decisions, increasing credibility and
FDA requires the submission of a CV for promoting accountability. Transparency
Food and Drug Administration each nominee as part of the nomination helps the Agency to more effectively
process for advisory committee protect and promote the public health.
[Docket No. FDA–2017–N–0001] members. FDA also requests that Ensuring greater public awareness of the
Advisory Committee Nominations; existing advisory committee members qualifications of individuals responsible
Modification To Process for Collecting submit updated versions of their CVs, for assisting the Agency in making
and Posting Curricula Vitae typically on a yearly basis. important policy decisions is an
In furtherance of FDA’s goal of important factor in ensuring such
AGENCY: Food and Drug Administration, ensuring transparency regarding the transparency. Posting the CVs of
HHS. qualifications of individuals selected to advisory committee members helps
ACTION: Notice. serve on FDA advisory committees, and increase public awareness.
in recognition that individual advisory Additionally, requiring advisory
SUMMARY: The Food and Drug committee members are best situated to committee nominees and advisory
Administration (FDA, Agency, or we) is evaluate the confidentiality of committee members to attest that their
modifying the process by which we information contained in their CVs, CVs do not include any confidential
collect and post curricula vitae (CVs) of including any considerations raised by information, including information
advisory committee members so that the their relationships and agreements with pertaining to third parties that they are
CVs will be posted to our Web site third parties, FDA will be requiring that not permitted to disclose, will help
without removing or redacting any all CVs submitted as part of the conserve limited FDA resources by
information. Posting CVs without nomination process for positions on ensuring that the individual most
removing or redacting any information FDA advisory committees be familiar with the information contained
will increase the transparency of FDA’s accompanied by a written consent form in the CV, as well as any contractual or
selection of officials who serve on stating that, if the nominee is accepted confidentiality agreements that might
advisory committees, and will ensure as a member of an FDA advisory affect their ability to disclose that
greater public access to the committee, the individual consents to information, assumes the responsibility
qualifications of advisory committee the publication of the individual’s CV to for determining whether the information
members on an ongoing basis. Because FDA’s Web site, without FDA removing may be released publicly. Because
advisory committee members are best or redacting any information. The advisory committee nominees and
situated to determine whether there is consent form requires that the nominee members are most familiar with the
confidential information in their CVs, affirm that the CV does not include any information contained in their CVs,
this modified collection and posting confidential information, including FDA will not be advising potential or
process will conserve FDA resources information pertaining to third parties current members about whether specific
because FDA personnel will no longer that the nominee is not permitted to
sradovich on DSK3GMQ082PROD with NOTICES
information in their CVs is confidential
be responsible for reviewing and disclose. A nominee will be required to or otherwise should be removed.
redacting the CVs. submit a signed consent form in order
DATES: All nominees for positions on an for the nomination to be considered II. Advisory Committee Member CVs
FDA advisory committee will be complete. The consent form will need to and Confidential Information
required to submit a consent form on or be submitted along with the four other The consent form will be required to
after the date of the Office of types of documents currently requested be submitted each time an advisory
Management and Budget (OMB) as part of the nomination process: (1) A committee nominee’s or existing
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![Federal Register / Vol. 82, No. 23 / Monday, February 6, 2017 / Notices 9383
advisory committee member’s CV is ACTION: Notice. marked and identified, as confidential,
submitted to FDA. All information if submitted as detailed in
contained in the CV submission for SUMMARY: The Food and Drug ‘‘Instructions.’’
individuals who are selected for or Administration (FDA or Agency) is Instructions: All submissions received
currently serving on an FDA advisory announcing an opportunity for public must include the Docket No. FDA–
committee will be available for public comment on the proposed collection of 2017–N–0366 for ‘‘Agency Information
posting. Specifically, for nominees for certain information by the Agency. Collection Activities: Proposed
positions on an FDA advisory Under the Paperwork Reduction Act of Collection; Comment Request;
committee, the required consent will 1995 (PRA), Federal Agencies are Collection of Nominations for
state as follows: required to publish notice in the Candidates to Serve on FDA’s Advisory
Federal Register concerning each Committees.’’ Received comments will
If I am selected to serve on an advisory proposed collection of information and
committee, I consent to publication of my be placed in the docket and, except for
to allow 60 days for public comment in
curriculum vitae (CV), and any subsequent those submitted as ‘‘Confidential
updates to my CV that I provide FDA, on response to the notice. This notice
Submissions,’’ publicly viewable at
FDA’s Web site, without removing or solicits comments on the Agency’s
https://www.regulations.gov or at the
redacting any information. My CV does not process for collecting nominations of
Division of Dockets Management
include any confidential information, candidates to serve on FDA’s advisory
between 9 a.m. and 4 p.m., Monday
including information pertaining to third committees.
parties that I am not permitted to disclose. through Friday.
DATES: Submit either electronic or • Confidential Submissions—To
For existing advisory committee written comments on the collection of submit a comment with confidential
members who submit updated CVs, the information by April 7, 2017. information that you do not wish to be
required consent will state as follows: ADDRESSES: You may submit comments made publicly available, submit your
I consent to publication of my curriculum as follows: comments only as a written/paper
vitae (CV), and any subsequent updates to my submission. You should submit two
CV that I provide FDA, on FDA’s Web site, Electronic Submissions
copies total. One copy will include the
without removing or redacting any Submit electronic comments in the
information. My CV does not include any
information you claim to be confidential
following way: with a heading or cover note that states
confidential information, including • Federal eRulemaking Portal:
information pertaining to third parties that I ‘‘THIS DOCUMENT CONTAINS
am not permitted to disclose.
https://www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
instructions for submitting comments. Agency will review this copy, including
III. Date of Implementation Comments submitted electronically, the claimed confidential information, in
including attachments, to https:// its consideration of comments. The
All nominations for new advisory www.regulations.gov will be posted to
committee members will be required to second copy, which will have the
the docket unchanged. Because your claimed confidential information
be submitted through FDA’s Web site at comment will be made public, you are
https://www.accessdata.fda.gov/scripts/ redacted/blacked out, will be available
solely responsible for ensuring that your for public viewing and posted on
FACTRSPortal/FACTRS/index.cfm, or comment does not include any
any successor system, and the https://www.regulations.gov. Submit
confidential information that you or a both copies to the Division of Dockets
submission will be required to be third party may not wish to be posted,
accompanied by the required consent Management. If you do not wish your
such as medical information, your or name and contact information to be
form, on or after the date of OMB anyone else’s Social Security number, or
approval for this information collection. made publicly available, you can
confidential business information, such provide this information on the cover
All updated CVs for existing advisory as a manufacturing process. Please note
committee members will be required to sheet and not in the body of your
that if you include your name, contact comments and you must identify this
be submitted to FDA along with the information, or other information that
required consent form after March 8, information as ‘‘confidential.’’ Any
identifies you in the body of your information marked as ‘‘confidential’’
2017. comments, that information will be will not be disclosed except in
Dated: February 1, 2017. posted on https://www.regulations.gov. accordance with 21 CFR 10.20 and other
Leslie Kux, • If you want to submit a comment applicable disclosure law. For more
Associate Commissioner for Policy. with confidential information that you information about FDA’s posting of
[FR Doc. 2017–02411 Filed 2–3–17; 8:45 am] do not wish to be made available to the comments to public dockets, see 80 FR
BILLING CODE 4164–01–P
public, submit the comment as a 56469, September 18, 2015, or access
written/paper submission and in the the information at: http://www.fda.gov/
manner detailed (see ‘‘Written/Paper regulatoryinformation/dockets/
DEPARTMENT OF HEALTH AND Submissions’’ and ‘‘Instructions’’). default.htm.
HUMAN SERVICES Written/Paper Submissions Docket: For access to the docket to
Submit written/paper submissions as read background documents or the
Food and Drug Administration
follows: electronic and written/paper comments
[Docket No. FDA–2017–N–0366] • Mail/Hand delivery/Courier (for received, go to https://
written/paper submissions): Division of www.regulations.gov and insert the
Agency Information Collection docket number, found in brackets in the
sradovich on DSK3GMQ082PROD with NOTICES
Activities: Proposed Collection; Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers heading of this document, into the
Comment Request; Collection of ‘‘Search’’ box and follow the prompts
Nominations for Candidates To Serve Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments and/or go to the Division of Dockets
on the Food and Drug Administration’s Management, 5630 Fishers Lane, Rm.
submitted to the Division of Dockets
Advisory Committees 1061, Rockville, MD 20852.
Management, FDA will post your
AGENCY: Food and Drug Administration, comment, as well as any attachments, FOR FURTHER INFORMATION CONTACT: FDA
HHS. except for information submitted, PRA Staff, Office of Operations, Food
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Document Created: 2017-02-04 00:25:27
Document Modified: 2017-02-04 00:25:27
| 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 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. | |
| Contact | Questions should be sent electronically to [email protected], or by mail to Advisory Committee Oversight and Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5129, Silver Spring, MD 20993-0002. | |
| FR Citation | 82 FR 9382 |
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